Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT01141205
Status:
COMPLETED
Last Update Posted:
2013-08-08
First Post:
2010-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afo@ssi.dk', 'phone': '+45-32683460', 'title': 'Dr Anders Fomsgaard', 'organization': 'Statens Serum Institut'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'One participant in the vaccinee group of 18 individuals had a SAE (serious infection) not related to the vaccine. One participant in the saline placebo group of 5 individuals experienced a SAE (increase in liver enzymes) not related to the placebo saline.\n\nNone others experienced any AE was noted.', 'eventGroups': [{'id': 'EG000', 'title': 'AFO-18', 'description': '18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Saline', 'description': 'Saline injection', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Died of pneumonia', 'notes': 'One participant died of severe gastroenteritis and pneumonia unrelated to the vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Increase in liver enzymes', 'notes': 'One placebo (saline) participant got elevation of liverenzymes (unrelated to the placebo)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tolerability and Safety of the Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinee', 'description': 'participants receiving active peptide in CAF01 adjuvants vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'participants receiving saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months after end of treatment', 'description': 'We report here the numbers of participants with vaccine related adverse events degree 3 or 4.\n\nOur goal for safety and tolerability was: "Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE'}, {'type': 'SECONDARY', 'title': 'Induction of New T-cell Immune Response by the Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AFO-18', 'description': '18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)'}, {'id': 'OG001', 'title': 'Placebo Saline', 'description': 'Saline injection'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months after last immunisation', 'description': 'induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (\\> 50 sfu/mio PBMC).', 'unitOfMeasure': 'ELISPOT responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes'}, {'type': 'SECONDARY', 'title': 'Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinee', 'description': 'participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.'}, {'id': 'OG001', 'title': 'Saline', 'description': 'Placebo participants receiving sterile saline i.m.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months post immunization', 'description': 'changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log', 'unitOfMeasure': 'participants with lowering of VL', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants minus drop outs and participants withdrawn by them selves or by the physicians'}, {'type': 'SECONDARY', 'title': 'Increase in Blood CD4 T-cell Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccinee', 'description': 'participants receiving active peptide in CAF01 adjuvants vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'participants receiving saline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 6 months post vaccination', 'description': 'Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of \\>100 CD4 Tcell per microliter', 'unitOfMeasure': 'participants with increased CD4 count', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants minus drop-outs and withdrawn participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AFO-18', 'description': '18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8'}, {'id': 'FG001', 'title': 'Saline', 'description': 'Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'medical clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AFO-18', 'description': '18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)'}, {'id': 'BG001', 'title': 'Saline', 'description': 'Saline injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '2', 'groupId': 'BG000'}, {'value': '29', 'spread': '2', 'groupId': 'BG001'}, {'value': '32', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Guinea-Bissau', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-02', 'studyFirstSubmitDate': '2010-06-09', 'resultsFirstSubmitDate': '2012-06-13', 'studyFirstSubmitQcDate': '2010-06-09', 'lastUpdatePostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-13', 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability and Safety of the Treatment.', 'timeFrame': 'up to 6 months after end of treatment', 'description': 'We report here the numbers of participants with vaccine related adverse events degree 3 or 4.\n\nOur goal for safety and tolerability was: "Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4".'}], 'secondaryOutcomes': [{'measure': 'Induction of New T-cell Immune Response by the Vaccine', 'timeFrame': 'up to 6 months after last immunisation', 'description': 'induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (\\> 50 sfu/mio PBMC).'}, {'measure': 'Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log', 'timeFrame': 'up to 6 months post immunization', 'description': 'changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log'}, {'measure': 'Increase in Blood CD4 T-cell Counts', 'timeFrame': 'up to 6 months post vaccination', 'description': 'Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of \\>100 CD4 Tcell per microliter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AIDS vaccines', 'HIV-1 vaccine', 'Therapeutic vaccine', 'Cellular immunity'], 'conditions': ['Aids, Cdc Group I']}, 'referencesModule': {'references': [{'pmid': '23634822', 'type': 'RESULT', 'citation': 'Roman VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, da Silva Te D, Rodrigues CM, Janitzek CM, Vinner L, Katzenstein TL, Andersen P, Kromann I, Andreasen LV, Karlsson I, Fomsgaard A. Therapeutic vaccination using cationic liposome-adjuvanted HIV type 1 peptides representing HLA-supertype-restricted subdominant T cell epitopes: safety, immunogenicity, and feasibility in Guinea-Bissau. AIDS Res Hum Retroviruses. 2013 Nov;29(11):1504-12. doi: 10.1089/AID.2013.0076. Epub 2013 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1.\n\nTarget group: Untreated healthy individuals with chronic HIV-1 infection.\n\nPurpose: The primary purpose is to evaluate tolerability and safety of the vaccine.\n\nThe secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of immunity, lowering of viral load, induction of escape mutations in the virus and improvement in the patient CD4 lymphocyte blood counts.\n\nThe third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization study in a poorly-resourced African setting.\n\nDesign: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in West Africa.\n\nNumbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).', 'detailedDescription': 'The HIV infection does not leave lifelong immunity, but leads to break down of the immune system, opportunistic infections and death. The immunity obtained by the infection itself can only partially contain the HIV infection. The purpose with a targeted therapeutic vaccination is therefore in addition to the existing immunity to induce a broader, more powerful and more rationally or better directed immunity than the one induced by the "natural" HIV-1 infection. This would potentially lower the viral load in the blood making it more difficult to spread the virus to others and prolong the time to AIDS disease and medical treatment. There is a need for new rational vaccination possibilities, able to prevent (HIV) disease, postpone the need for antiretroviral medical treatment, prolong the life, and limit spread of HIV-1 in the population. The present protocol seak to introduce such a new immune treatment principle for HIV-1 infected individuals. In this study, individuals with chronic HIV-1 infection will be vaccinated with selected synthetic HIV immune-peptides representing new discovered conserved target´s on the virus. The vaccine should induce new immunity against several epitope targets on their HIV, whereby the HIV infection may be controlled for a longer time by the immune system. The purpose of the study is primarily to evaluate the safety and tolerability of the vaccine and secondary to evaluate the immunological and antiviral response in the vaccinated individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HIV-1 seropositive with measurable viral load \\>10e3 copies/ml and CD4+ T-cell count \\>400 CD4+ cells/µl.\n2. Not in Antiretroviral Therapy (\\>1 year).\n3. Male or female with age between 18 and 50 years.\n4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin\n5. Expected to follow the instructions.\n6. Written informed consent after oral and written information.\n\nExclusion Criteria:\n\n1. Vaccinated with other vaccines within 3 months before the first vaccination.\n2. Treated with immune modulating medicine within 3 month before the first immunization.\n3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB\n4. Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.\n5. Severe allergy or earlier anaphylactic reactions.\n6. Active autoimmune diseases.\n7. Simultaneous treatment with other experimental drugs.\n8. Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.\n9. Pregnancy"}, 'identificationModule': {'nctId': 'NCT01141205', 'acronym': 'HIV-BIS', 'briefTitle': 'HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease', 'organization': {'class': 'OTHER', 'fullName': 'Statens Serum Institut'}, 'officialTitle': 'Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease', 'orgStudyIdInfo': {'id': 'HIV-BIS NCP03/2009'}, 'secondaryIdInfos': [{'id': 'EDCTP_MSI.2009.10800.001', 'type': 'OTHER_GRANT', 'domain': 'EDCTP_MSI.2009.10800.001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AFO-18', 'description': '18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)', 'interventionNames': ['Biological: AFO-18']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'AFO-18', 'type': 'BIOLOGICAL', 'otherNames': ['CAF01', 'HIV-1 peptides'], 'description': '18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)', 'armGroupLabels': ['AFO-18']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['NaCl'], 'description': '1.2 ml saline intramuscularly', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bissau', 'state': 'Guinea-Bissau', 'country': 'Guinea-Bissau', 'facility': 'Hospital Nacional Simao Mendes', 'geoPoint': {'lat': 11.86357, 'lon': -15.59767}}, {'city': 'Bissau', 'country': 'Guinea-Bissau', 'facility': 'Hospital Nacional Simao Mendes', 'geoPoint': {'lat': 11.86357, 'lon': -15.59767}}], 'overallOfficials': [{'name': 'Anders Fomsgaard, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Zacarias Jose da Silva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Statens Serum Institut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of the Interior and Health, Denmark', 'class': 'OTHER_GOV'}, {'name': 'European and Developing Countries Clinical Trials Partnership (EDCTP)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Doctor', 'investigatorFullName': 'Anders Fomsgaard', 'investigatorAffiliation': 'Statens Serum Institut'}}}}