Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne (NCT06316297)
A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.
Who can join: Review the eligibility criteria below.
Location: Center for Dermatology and Plastic Surgery- Site Number : 8400111 — Scottsdale, Arizona
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (94 Sites)
Showing the first 25 of 94 sites.
- Center for Dermatology and Plastic Surgery- Site Number : 8400111 — Scottsdale, Arizona
- Private Practice - Dr. Francisco Badar- Site Number : 8400067 — Cerritos, California
- Encino Research Center- Site Number : 8400033 — Encino, California
- Paradigm Clinical Research Centers- Site Number : 8400064 — La Mesa, California
- Sunwise Clinical Research- Site Number : 8400108 — Lafayette, California
- Chemidox Clinical Trials- Site Number : 8400075 — Lancaster, California
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058 — Los Angeles, California
- LA Universal Research Center- Site Number : 8400059 — Los Angeles, California
- Alliance Clinical - West Hills- Site Number : 8400131 — Los Angeles, California
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400076 — North Hollywood, California
- Northridge Clinical Trials - Northridge- Site Number : 8400053 — Northridge, California
- Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099 — Oceanside, California
- Cura Clinical Research - Oxnard- Site Number : 8400062 — Oxnard, California
- Amicis Research Center, LLC- Site Number : 8400110 — Palmdale, California
- Empire Clinical Research - Pomona- Site Number : 8400055 — Pomona, California
- Peninsula Research Associates- Site Number : 8400102 — Rolling Hills Estates, California
- Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103 — San Diego, California
- California Research Foundation- Site Number : 8400095 — San Diego, California
- NorthBay Clinical Research- Site Number : 8400066 — Santa Rosa, California
- Encore Medical Research of Boynton Beach- Site Number : 8400116 — Boynton Beach, Florida
- Driven Research- Site Number : 8400135 — Coral Gables, Florida
- HealthMed Clinical Center- Site Number : 8400071 — Coral Gables, Florida
- Universal Medical Research - Coral Gables- Site Number : 8400081 — Coral Gables, Florida
- Genomics Medical Research- Site Number : 8400120 — Cutler Bay, Florida
- Direct Helpers Research Center- Site Number : 8400118 — Hialeah, Florida
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: contact-us@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Acne clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.