Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-21 @ 1:46 PM
Study NCT ID:
NCT00536120
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2007-09-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069442', 'term': 'Natalizumab'}, {'id': 'C032808', 'term': 'keyhole-limpet hemocyanin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogenidec.com', 'title': 'Biogen Idec Medical Director', 'organization': 'Biogen Idec Inc.'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were collected from dosing at the Baseline Visit (Month 0) until the participant's End of Study Visit (Month 8). Serious adverse events were collected from screening until 12 weeks following the participant's last dose of Tysabri.", 'description': 'Data for the Tysabri Plus Vaccinations group covers the entire study period, and data for the Vaccines Only group covers only the immunization period.', 'eventGroups': [{'id': 'EG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.", 'otherNumAtRisk': 30, 'otherNumAffected': 25, 'seriousNumAtRisk': 30, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Vaccinations Only', 'description': "Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.", 'otherNumAtRisk': 30, 'otherNumAffected': 19, 'seriousNumAtRisk': 30, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'injection site erythrema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'herpes zoster disseminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}, {'id': 'OG001', 'title': 'Vaccinations Only', 'description': "Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2."}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)', 'description': 'KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at Day 28. No imputation methods were used in the primary analyses.', 'anticipatedPostingDate': '2011-07'}, {'type': 'PRIMARY', 'title': 'Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}, {'id': 'OG001', 'title': 'Vaccinations Only', 'description': "Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2."}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)', 'description': 'Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at Day 28 and a pre-immunization antibody value ≤ 3.5 IU/mL. No imputation methods were used in the primary analyses.', 'anticipatedPostingDate': '2011-07'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}], 'classes': [{'title': 'CD3+', 'categories': [{'measurements': [{'value': '39.6', 'spread': '26.84', 'groupId': 'OG000'}]}]}, {'title': 'CD4+', 'categories': [{'measurements': [{'value': '35.7', 'spread': '26.83', 'groupId': 'OG000'}]}]}, {'title': 'CD8+', 'categories': [{'measurements': [{'value': '51.8', 'spread': '36.68', 'groupId': 'OG000'}]}]}, {'title': 'CD16+/CD56+', 'categories': [{'measurements': [{'value': '68.7', 'spread': '79.83', 'groupId': 'OG000'}]}]}, {'title': 'CD19+', 'categories': [{'measurements': [{'value': '135.2', 'spread': '82.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline), Month 3', 'description': 'The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}], 'classes': [{'title': 'CD3+', 'categories': [{'measurements': [{'value': '52.4', 'spread': '34.19', 'groupId': 'OG000'}]}]}, {'title': 'CD4+', 'categories': [{'measurements': [{'value': '48.2', 'spread': '32.71', 'groupId': 'OG000'}]}]}, {'title': 'CD8+', 'categories': [{'measurements': [{'value': '67.1', 'spread': '42.41', 'groupId': 'OG000'}]}]}, {'title': 'CD16+/CD56+', 'categories': [{'measurements': [{'value': '73.5', 'spread': '73.20', 'groupId': 'OG000'}]}]}, {'title': 'CD19+', 'categories': [{'measurements': [{'value': '164.8', 'spread': '85.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline), Month 6', 'description': 'The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had received at least 3 doses of Tysabri per protocol; those with insufficient Tysabri dosing or protocol violations were excluded from the relevant analysis population.'}, {'type': 'SECONDARY', 'title': 'Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}], 'classes': [{'title': 'Baseline; n=27', 'categories': [{'measurements': [{'value': '9.9', 'spread': '16.72', 'groupId': 'OG000'}]}]}, {'title': 'Month 3; n=28', 'categories': [{'measurements': [{'value': '72.7', 'spread': '28.93', 'groupId': 'OG000'}]}]}, {'title': 'Month 6; n=24', 'categories': [{'measurements': [{'value': '80.5', 'spread': '24.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline), Month 3, and Month 6', 'description': 'Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.', 'unitOfMeasure': 'percent saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}], 'classes': [{'title': 'Baseline; n=27', 'categories': [{'measurements': [{'value': '633.7', 'spread': '139.73', 'groupId': 'OG000'}]}]}, {'title': 'Month 3; n=28', 'categories': [{'measurements': [{'value': '419.5', 'spread': '158.95', 'groupId': 'OG000'}]}]}, {'title': 'Month 6; n=24', 'categories': [{'measurements': [{'value': '434.3', 'spread': '167.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Baseline), Month 3, and Month 6', 'description': 'Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.', 'unitOfMeasure': 'mean fluorescent intensity (MFI)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had received at least 1 dose of Tysabri and had at least 1 post-baseline assessment. n=number of participants with measurement at given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}, {'id': 'FG001', 'title': 'Vaccinations Only', 'description': "Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Positive for Anti-natalizumab Antibodies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision Due to Lab Values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Steroid Use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Missed Study Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled in the study at 10 investigational sites in the US. Study enrollment began on 07 January 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tysabri Plus Vaccinations', 'description': "Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH."}, {'id': 'BG001', 'title': 'Vaccinations Only', 'description': "Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '8.34', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '9.86', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '9.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time Since First MS Symptoms', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '8.5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '25'}, {'value': '8.0', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time Since First MS Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '5.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '19'}, {'value': '5.5', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Relapses in 3 Years Prior to Screening', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '2.65', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.83', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '2.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Relapses in 12 Months Prior to Screening', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.07', 'groupId': 'BG000'}, {'value': '1.0', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Expanded Disability Status Scale at Screening', 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '3.00', 'groupId': 'BG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '3.00', 'groupId': 'BG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Expanded Disability Status Scale (EDSS) measures physical disability on a scale from 0.0 (no disability) to 10.0 (death due to disability) in 0.5-point increments.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Circulating Lymphocyte Subsets', 'classes': [{'title': 'CD3+; n=24', 'categories': [{'measurements': [{'value': '1261.5', 'spread': '309.47', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Calculated for Tysabri arm only.', 'groupId': 'BG001'}, {'value': '1261.5', 'spread': '309.47', 'groupId': 'BG002'}]}]}, {'title': 'CD4+; n=24', 'categories': [{'measurements': [{'value': '905.2', 'spread': '299.51', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Calculated for Tysabri arm only.', 'groupId': 'BG001'}, {'value': '905.2', 'spread': '299.51', 'groupId': 'BG002'}]}]}, {'title': 'CD8+; n=24', 'categories': [{'measurements': [{'value': '344.6', 'spread': '123.91', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Calculated for Tysabri arm only.', 'groupId': 'BG001'}, {'value': '344.6', 'spread': '123.91', 'groupId': 'BG002'}]}]}, {'title': 'CD16+; n=24', 'categories': [{'measurements': [{'value': '179.2', 'spread': '106.12', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Calculated for Tysabri arm only.', 'groupId': 'BG001'}, {'value': '179.2', 'spread': '106.12', 'groupId': 'BG002'}]}]}, {'title': 'CD19+; n=24', 'categories': [{'measurements': [{'value': '269.8', 'spread': '123.00', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Calculated for Tysabri arm only.', 'groupId': 'BG001'}, {'value': '269.8', 'spread': '123.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) at Baseline', 'unitOfMeasure': 'lymphocyte count/µL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2007-09-25', 'resultsFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-30', 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Keyhole Limpet Hemocyanin (KLH) Responders at Day 28 Post-Vaccination', 'timeFrame': '28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)', 'description': 'KLH responders were defined as those participants who had at least a 2-fold increase over pre-immunization level of anti-KLH antibodies in their blood at 28 days after vaccination with KLH.'}, {'measure': 'Percentage of Tetanus Diphtheria Toxoid (Td) Responders at Day 28 Post-Vaccination', 'timeFrame': '28 days after immunization (Day 28 for Vaccinations Only Group/Day 196 for Tysabri Plus Vaccinations Group)', 'description': 'Tetanus responders were defined as participants who had at least a 2-fold increase over pre-immunization levels of anti-tetanus antibodies in their blood at 28 days after they were immunized with tetanus.'}], 'secondaryOutcomes': [{'measure': 'Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 3 of Tysabri Therapy', 'timeFrame': 'Month 0 (Baseline), Month 3', 'description': 'The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).'}, {'measure': 'Mean Percentage Change From Baseline in Circulating Lymphocyte Subsets CD3+, CD4+, CD8+, CD19+, and CD56+ at Month 6 of Tysabri Therapy', 'timeFrame': 'Month 0 (Baseline), Month 6', 'description': 'The effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) was calculated as a percentage change from baseline pre-treatment values (based on absolute count).'}, {'measure': 'Mean Alpha4-Integrin Saturation at Baseline, Month 3, and Month 6', 'timeFrame': 'Month 0 (Baseline), Month 3, and Month 6', 'description': 'Measurement of the degree of natalizumab saturation of the alpha4 integrin on peripheral blood mononuclear cells was accomplished by staining cells with phycoerythrin conjugated anti human IgG4 antibody (hIgG4-PE) to label the cell-bound natalizumab, followed by flow cytometric detection and quantification.'}, {'measure': 'Mean Alpha4-Integrin Expression at Baseline, Month 3, and Month 6', 'timeFrame': 'Month 0 (Baseline), Month 3, and Month 6', 'description': 'Alpha4-integrin expression is the mean fluorescent intensity (MFI), a measure of fluorescence intensity often used to monitor changes in surface antigen modulation in flow cytometry. There is no reference range for this test, which was developed at Biogen Idec.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MS', 'Multiple sclerosis', 'Relapsing forms of Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '24731783', 'type': 'BACKGROUND', 'citation': 'Kaufman M, Pardo G, Rossman H, Sweetser MT, Forrestal F, Duda P. Natalizumab treatment shows no clinically meaningful effects on immunization responses in patients with relapsing-remitting multiple sclerosis. J Neurol Sci. 2014 Jun 15;341(1-2):22-7. doi: 10.1016/j.jns.2014.03.035. Epub 2014 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study were: to evaluate the effect of Tysabri® (natalizumab) on antibody responses after immunization with a neoantigen (keyhole limpet hemocyanin \\[KLH\\]) and a recall antigen (tetanus toxoid \\[Td\\]), and to evaluate the effect of Tysabri on circulating lymphocyte subsets (CD3+, CD4+, CD8+, CD19+, and CD56+) over time in participants with relapsing forms of multiple sclerosis (MS). The secondary objective was to assess alpha4-integrin saturation and alpha4-integrin expression levels over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* able to give written informed consent\n* diagnosis of a relapsing form of MS and must fall within the therapeutic indication stated in the approved label for Tysabri\n* aged 18-60 years, inclusive at the time of consent\n* free of signs and symptoms suggestive of any serious opportunistic infection, based on medical history, physical examination, or laboratory testing\n* must have a known history of tetanus toxoid immunization\n\nMajor Exclusion Criteria:\n\n* tetanus toxoid vaccination less than 2 years prior to Screening\n* known hypersensitivity to tetanus-diphtheria vaccine or KLH or any other administered vaccinations or their components (such as thimerosal)\n* known allergy to shellfish\n* history of active tuberculosis or undergoing treatment for tuberculosis\n* previous exposure to KLH or vaccines containing KLH components (e.g., cancer vaccines)\n* known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection\n* history of, or available abnormal laboratory results indicative of any significant disease\n* history of malignancy\n* history of organ transplantation (including anti-rejection therapy)\n* history of severe allergic or anaphylactic reactions or known drug hypersensitivity\n* a clinically significant infectious illness within 30 days prior to the Screening visit\n* prior exposure to Tysabri, rituximab, any murine protein, or any therapeutic monoclonal antibody at any time\n* receipt of intravenous (IV) or intramuscular (IM) immunoglobulin within 6 months of screening\n* live virus, bacterial vaccines, or any other vaccines within 3 months of screening\n* treatment with immunosuppressant medications within 6 months prior to screening\n* treatment with cyclophosphamide within 1 year prior to screening\n* treatment with immunomodulatory medications (interferon beta and glatiramer acetate) within 2 weeks prior to screening\n* treatment with systemic corticosteroids within 4 weeks prior to screening\n* treatment with any investigational product or approved therapy or vaccination for investigational use within 6 months prior to Screening\n* women who are breastfeeding, pregnant, or planning to become pregnant during the study\n* female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception during the study'}, 'identificationModule': {'nctId': 'NCT00536120', 'briefTitle': 'The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': '101MS404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tysabri Plus Vaccinations', 'description': "Participants receive 9 monthly doses of Tysabri 300 mg intravenous (IV), and receive vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin \\[KLH\\] and tetanus diphtheria toxoid \\[Td\\], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.", 'interventionNames': ['Biological: BG00002 (natalizumab)', 'Biological: keyhole limpet hemocyanin (KLH)', 'Biological: tetanus diphtheria toxoid vaccine (Td)']}, {'type': 'OTHER', 'label': 'Vaccinations Only', 'description': "Participants receive only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They do not receive any treatment for their MS and remain in the study through Month 2.", 'interventionNames': ['Biological: keyhole limpet hemocyanin (KLH)', 'Biological: tetanus diphtheria toxoid vaccine (Td)']}], 'interventions': [{'name': 'BG00002 (natalizumab)', 'type': 'BIOLOGICAL', 'otherNames': ['Tysabri'], 'armGroupLabels': ['Tysabri Plus Vaccinations']}, {'name': 'keyhole limpet hemocyanin (KLH)', 'type': 'BIOLOGICAL', 'otherNames': ['Immucothel'], 'description': "KLH 1 mg administered subcutaneously (SC) in accordance with the Immucothel investigator's brochure.", 'armGroupLabels': ['Tysabri Plus Vaccinations', 'Vaccinations Only']}, {'name': 'tetanus diphtheria toxoid vaccine (Td)', 'type': 'BIOLOGICAL', 'description': "Td administered in accordance with the manufacturer's prescribing information.", 'armGroupLabels': ['Tysabri Plus Vaccinations', 'Vaccinations Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 1', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site 3', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '73130', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site 5', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '75214', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site 2', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Research Site 4', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}