Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:35 AM
Study NCT ID:
NCT07399951
Status:
COMPLETED
Last Update Posted:
2026-02-10
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Washington University WU 409: Immune Responses to Rabies Vaccine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011819', 'term': 'Rabies Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'RANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either:\n\nArm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0 Once 5 participants are enrolled to arms 1 and 2 participants will be randomized 1:3 to either Arm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0 Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28\n\nTO\n\nRANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either:\n\nArm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm-2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0\n\nOnce 20 participants are enrolled to arms 1 and 2 10 more participants will be enrolled to:\n\nArm-3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of antibody titers at D28 versus baseline', 'timeFrame': '28 days', 'description': 'Comparison of antibody titers at D28 versus baseline'}, {'measure': 'Comparison of antibody titers at D365 versus baseline', 'timeFrame': '365 days', 'description': 'Comparison of antibody titers at D365 versus baseline'}], 'secondaryOutcomes': [{'measure': 'Frequency serious adverse events', 'timeFrame': 'time of consent to day 365', 'description': 'Number of serious adverse events reported'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).', 'detailedDescription': 'This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).\n\nRANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either:\n\nArm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm-2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0\n\nOnce 20 participants are enrolled to arms 1 and 2 10 more participants will be enrolled to:\n\nArm-3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28\n\nWe plan to enroll 30 evaluable participants in the coming year, anticipating up to 30 enrolling in the optional FNA and BMA assessments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Healthy participants over 18 years of age. 2. Able to understand and give informed consent. 3. Willing to receive rabies vaccine 4. In stable health, as determined by medical history and targeted physical exam related to this history.\n\n5\\. For those willing to give FNA, CBL and BMA samples, Willing to: give FNA specimens OR give CBL specimens OR give bone marrow aspirates OR give both FNA and BMA specimens OR give both FNA and CBL specimens OR give FNA, CBL and BMA specimens\n\nExclusion Criteria:\n\n1. Receipt of prior rabies vaccination or risk for rabies exposure requiring standard vaccination\n2. Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.\n3. Has received systemic immunosuppressants or immune-modifying drugs for \\> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.\n4. Is acutely ill or febrile (temperature \\>38.0 C \\[100.4F\\] less than 72 hours prior to or at the day 1 visit. Participants who meet this criteria may be rescheduled.\n5. Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.\n6. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.\n7. Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.\n8. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.\n9. Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.\n10. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.\n11. Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core lymph node biopsy for participants willing to have those procedures done\n12. Known IgA deficiency, as this is a known risk factor for anaphylactic reactions to Rabies immunoglobulin.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT07399951', 'briefTitle': 'Washington University WU 409: Immune Responses to Rabies Vaccine.', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'WU 409: Immune Responses to Rabies Vaccine in the Presence and Absence of Neutralizing Antibodies', 'orgStudyIdInfo': {'id': '202305094'}, 'secondaryIdInfos': [{'id': 'PJ000006488', 'type': 'OTHER_GRANT', 'domain': 'Institutional Grant/Award Human Clinical Studies fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm-1 Imovax or RabAvert- 2 doses 7 days apart', 'description': 'Imovax or RabAvert- 2 doses 7 days apart', 'interventionNames': ['Drug: Imovax', 'Drug: RabAvert']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0', 'description': 'Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0', 'interventionNames': ['Drug: Imovax', 'Drug: RabAvert', 'Drug: HyperRAB']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28', 'description': 'Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28', 'interventionNames': ['Drug: Imovax', 'Drug: RabAvert', 'Drug: HyperRAB']}], 'interventions': [{'name': 'Imovax', 'type': 'DRUG', 'description': 'Rabies Vaccine', 'armGroupLabels': ['Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0', 'Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28', 'Arm-1 Imovax or RabAvert- 2 doses 7 days apart']}, {'name': 'RabAvert', 'type': 'DRUG', 'otherNames': ['RabAver'], 'description': 'Rabies Vaccine', 'armGroupLabels': ['Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0', 'Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28', 'Arm-1 Imovax or RabAvert- 2 doses 7 days apart']}, {'name': 'HyperRAB', 'type': 'DRUG', 'description': 'rabies immune globulin (human)', 'armGroupLabels': ['Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0', 'Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine Infectious Disease Clinical Trials Unit.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Rachel Presti, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'ICF is attached Protocol is attached CSR within 30 days of completion.', 'ipdSharing': 'YES', 'accessCriteria': 'ICF is attached Protocol is attached'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Department of Medicine, Division of Infectious Disease Washington University, St. Louis, MO', 'investigatorFullName': 'Rachel Presti', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}