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NCT04222985 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04222985: Clinical Trial Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04222985 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04222985, a Phase 1 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary objectives of the study are: * To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). * To evaluate the efficacy of the investigational vaccine regimens with respect to: * the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule * the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: * To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
Primary Outcome
Unsolicited systemic adverse events occurring immediately after vaccination
Interventions
- BIOLOGICAL HSV 2 Formulation 1
- BIOLOGICAL HSV 2 Formulation 2
- BIOLOGICAL HSV 2 Formulation 3
- BIOLOGICAL HSV 2 Formulation 4
- BIOLOGICAL HSV 2 Formulation 5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 1 |
Why NCT04222985 stopped before completion
NCT04222985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which HSV 2 Formulation 1 is the first listed.
NCT04222985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04222985 about?
NCT04222985 is a clinical study titled "Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2". The primary objectives of the study are: * To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). * To evaluate the efficacy of the investigational vaccine regimens with respect to: * the frequency of herpes simplex virus (HSV) deox...
What is the current status of trial NCT04222985?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-02-18. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT04222985?
The interventions under investigation include: HSV 2 Formulation 1 (BIOLOGICAL), HSV 2 Formulation 2 (BIOLOGICAL), HSV 2 Formulation 3 (BIOLOGICAL), HSV 2 Formulation 4 (BIOLOGICAL), HSV 2 Formulation 5 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04222985?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04222985's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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