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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915212
The ClinicalTrials.gov registry entry for NCT01915212 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 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 2 interventions - of which Placebo is the first listed.
NCT01915212 reports 0 study locations.
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.
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