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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 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 24 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04222985
The ClinicalTrials.gov registry entry for NCT04222985 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which HSV 2 Formulation 1 is the first listed.
NCT04222985 reports 0 study locations.
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.
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