Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

Part of paid clinical trials in Encino, California.

Sponsor
Sanofi Pasteur, a Sanofi Company
Study ID
NCT07013747
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acne

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Acne mRNA vaccine — BIOLOGICAL
    Pharmaceutical form: suspension for injection Route of administration: intramuscular
  • Placebo — OTHER
    Pharmaceutical form: liquid solution for injection Route of administration: intramuscular

Study Details

The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.

Key Dates

Start date
Jul 3, 2025
Status verified
Aug 2025
Primary completion
Jun 19, 2029
Completion
Jun 19, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sentinel Cohort Arm 1
    Participants will receive 2 Acne mRNA Vaccine injections
  • Placebo Comparator: Sentinel Cohort Arm 2
    Participants will receive 2 Placebo injections
  • Experimental: Main Cohort Arm 1
    Participants will receive 2 Acne mRNA Vaccine injections
  • Placebo Comparator: Main Cohort Arm 2
    Participants will receive 2 Placebo injections

Primary Outcome Measure

Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) [ Time Frame: In 30 minutes after each administration ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Encino Research Center- Site Number : 8400008EncinoCalifornia91436-
Moore Clinical Research - Brandon- Site Number : 8400007BrandonFlorida33511-
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006JacksonvilleFlorida32216-
DelRicht Research- Site Number : 8400003New OrleansLouisiana70115-

Find similar trials in Encino, CA

By research site
Encino Research Center· Encino, CAMoore Clinical Research - Brandon· Brandon, FLEncore Research Group-Jacksonville Center for Clinical Research· Jacksonville, FLDelRicht Research· New Orleans, LA

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