TerminatedPhase 1

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

Stopped: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A

United States24 participantsStarted 2020-02-18

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria : * Aged 18 to 55 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits * HSV-2 seropositive confirmed by Western blot * A history of established HSV-2 infection ≥ 1 year * A history of at least 2 and no more than 9 reported HSV clinical recurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 2 and no more than 9 reported clinical recurrences in the 12 months prior to initiation suppressive therapy * For Part A and Part B, the participant is willing to refrain from using suppressive antiviral therapy starting 5 days before the first vaccination visit and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods, and up to 6 months after the second vaccination visit * For Part A and Part B, the participant is willing to refrain from using antiviral therapy to treat recurrences starting 5 days before V01 and up to 6 months after the second vaccination visit; and for Part B, throughout the 3, 60-day swabbing periods (i.e., up to 60 days after the second vaccination visit) Exclusion criteria: * For Part A, the participant is pregnant, or lactating, or of childbearing potential and not …

What they're measuring

Number of participants with immediate adverse events

Timeframe: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination

Number of participants with solicited injection site and systemic reactions

Timeframe: Within 7 days after vaccination

Number of participants with unsolicited adverse events

Timeframe: Within 30 days after vaccination

Number of participants with medically-attended adverse events (MAAEs)

Timeframe: From Day 0 to Month 14

Number of participants with adverse events of special interest (AESIs)

Timeframe: From Day 0 to Month 14

Number of participants with serious adverse events (SAEs)

Timeframe: From Screening to Month 14

Number of participants with out-of-range biological test results

Timeframe: From Day 8 to Day 30

Viral genital shedding rate

Trial details

NCT IDNCT04222985

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-19

View on ClinicalTrials.gov More Genital Herpes trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with immediate adverse events

Timeframe: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination

Number of participants with solicited injection site and systemic reactions

Timeframe: Within 7 days after vaccination

Number of participants with unsolicited adverse events

Timeframe: Within 30 days after vaccination

Number of participants with medically-attended adverse events (MAAEs)

Timeframe: From Day 0 to Month 14

Number of participants with adverse events of special interest (AESIs)

Timeframe: From Day 0 to Month 14

Number of participants with serious adverse events (SAEs)

Timeframe: From Screening to Month 14

Number of participants with out-of-range biological test results

Timeframe: From Day 8 to Day 30

Viral genital shedding rate