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NCT01989533 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01989533 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 62 participants.
The verdict
NCT01989533, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Background: \- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections. Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate. Objective: \- To test the safety of experimental HIV vaccines. Eligibility: \- Healthy adults 18-49 years old. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. * Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix. * Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour. * Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay. * Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum. * Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.
Interventions
- BIOLOGICAL Ad4-mgag
- BIOLOGICAL Ad4-EnvC150
- BIOLOGICAL gp 120 Protein Boost
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2019-04-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989533
The ClinicalTrials.gov registry entry for NCT01989533 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ad4-mgag is the first listed.
NCT01989533 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01989533 about?
NCT01989533 is a clinical study titled "Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers". Background: \- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers...
What is the current status of trial NCT01989533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2013-11-19. Estimated completion is 2019-04-08.
What interventions are being tested in trial NCT01989533?
The interventions under investigation include: Ad4-mgag (BIOLOGICAL), Ad4-EnvC150 (BIOLOGICAL), gp 120 Protein Boost (BIOLOGICAL).
Who is sponsoring clinical trial NCT01989533?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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