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NCT01915212 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT01915212: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01915212 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915212, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
Background: \- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe. Objectives: \- To test whether a new herpes vaccine is safe. Eligibility: \- Healthy adults 18 40 years old. Design: * Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year. * Each vaccination visit will last about 4 hours. * Participants will be screened with a medical history and physical exam. * Participants will have a blood sample taken. * Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction. * Participants will be given a diary card to record any symptoms they may feel later. * At follow-up visits, participants will give a blood sample and answer health questions. * In the phone calls, participants will answer health questions.
Primary Outcome
Safety
Interventions
- OTHER Placebo
- BIOLOGICAL HSV529
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2013-09-26 |
| Est. Completion | 2017-03-06 |
| Phase | Phase 1 |
What the finished NCT01915212 record still lists
NCT01915212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01915212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915212 about?
NCT01915212 is a clinical study titled "Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection". Background: \- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could ...
What is the current status of trial NCT01915212?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2013-09-26. Estimated completion is 2017-03-06.
What interventions are being tested in trial NCT01915212?
The interventions under investigation include: Placebo (OTHER), HSV529 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01915212?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915212's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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