Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

NCT06316297 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: VBE00001U1111-1295-31542025-521740-38
• Study Type: interventional
• Target: 800
• Locations: 3 countries
• Sites: 93

Brief Summary

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (11)

• Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs

  Presence of unsolicited systemic adverse events (AEs) reported

  30 minutes after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions

  Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])

  Up to 7 days after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs

  Up to 28 days after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs

  Presence of medically attended adverse events (MAAEs)

  Up to 6 months after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with SAEs

  Presence of all serious adverse events (SAEs)

  Up to 6 months after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with AESIs

  Presence of AEs of special interest (AESIs)

  Up to 6 months after each administration

• Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)

  Through 7 days after administration (Day 8)

• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face

  At 2 months post last administration

• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face

  At 2 months post last administration

• Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at

  At 2 months post last administration

• Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs

  Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)

  Up to 38 or 40 months after first administration

Secondary Outcomes (12)

• Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of accine-antigen-specific serum antibody titers

  From baseline (Day 1) to 6 months post last administration

• Core Study - Main Cohort B: Absolute change from baseline (Day 1) in the total number of inflammatory acne lesions on face

  At 1 month post first administration until 9 months post last administration

• Core Study - Main Cohorts A and B: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face

  At 1 month post first administration until 6 or 9 months post last administration

• Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face

  At 1 month post first administration until 6 or 9 months post last administration

• Core Study - Main Cohorts A and B: Absolute change from baseline in IGA score

  At 1 month post first administration until 6 or 9 months post last administration

Study Arms (8)

Sentinel Cohort A - Experimental

EXPERIMENTAL

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

Biological: Acne mRNA vaccine

Sentinel Cohort A - Placebo

PLACEBO COMPARATOR

Two administrations of placebo will be injected

Other: Placebo

Sentinel Cohort B - Experimental

EXPERIMENTAL

Three administrations of the Acne mRNA vaccine will be injected in two increasing doses

Biological: Acne mRNA vaccine

Sentinel Cohort B - Placebo

PLACEBO COMPARATOR

Three administrations of placebo will be injected

Other: Placebo

Main Cohort A - Experimental

EXPERIMENTAL

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

Biological: Acne mRNA vaccine

Main Cohort A - Placebo

PLACEBO COMPARATOR

Two administrations of placebo will be injected

Other: Placebo

Main Cohort B - Experimental

EXPERIMENTAL

Three administrations of the Acne mRNA vaccine will be injected in two increasing doses

Biological: Acne mRNA vaccine

Main Cohort B - Placebo

PLACEBO COMPARATOR

Three administrations of placebo will be injected

Other: Placebo

Interventions

Acne mRNA vaccine BIOLOGICAL

Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular

Main Cohort A - Experimental; Main Cohort B - Experimental; Sentinel Cohort A - Experimental; Sentinel Cohort B - Experimental

Placebo OTHER

Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular

Main Cohort A - Placebo; Main Cohort B - Placebo; Sentinel Cohort A - Placebo; Sentinel Cohort B - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
• Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID-19) vaccine
• Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
• Use of any acne-affecting treatment without an appropriate washout period
• Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
• Previous vaccination against C. acnes with an investigational vaccine
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (93)

Center for Dermatology and Plastic Surgery- Site Number : 8400111

Scottsdale, Arizona, 85260, United States

RECRUITING

Private Practice - Dr. Francisco Badar- Site Number : 8400067

Cerritos, California, 90703, United States

RECRUITING

Encino Research Center- Site Number : 8400033

Encino, California, 91436, United States

RECRUITING

Paradigm Clinical Research Centers- Site Number : 8400064

La Mesa, California, 91942, United States

RECRUITING

Sunwise Clinical Research- Site Number : 8400108

Lafayette, California, 94549, United States

RECRUITING

Chemidox Clinical Trials- Site Number : 8400075

Lancaster, California, 93534, United States

RECRUITING

Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058

Los Angeles, California, 90027, United States

RECRUITING

LA Universal Research Center- Site Number : 8400059

Los Angeles, California, 90057, United States

RECRUITING

Alliance Clinical - West Hills- Site Number : 8400131

Los Angeles, California, 91307, United States

RECRUITING

Carbon Health - North Hollywood - NoHo West- Site Number : 8400076

North Hollywood, California, 91606, United States

RECRUITING

Northridge Clinical Trials - Northridge- Site Number : 8400053

Northridge, California, 91325, United States

RECRUITING

Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099

Oceanside, California, 92056, United States

RECRUITING

Cura Clinical Research - Oxnard- Site Number : 8400062

Oxnard, California, 93030, United States

RECRUITING

Amicis Research Center, LLC- Site Number : 8400110

Palmdale, California, 93551, United States

RECRUITING

Empire Clinical Research - Pomona- Site Number : 8400055

Pomona, California, 91767, United States

RECRUITING

Peninsula Research Associates- Site Number : 8400102

Rolling Hills Estates, California, 90274, United States

RECRUITING

Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103

San Diego, California, 92103, United States

RECRUITING

California Research Foundation- Site Number : 8400095

San Diego, California, 92123, United States

RECRUITING

NorthBay Clinical Research- Site Number : 8400066

Santa Rosa, California, 95405, United States

RECRUITING

Encore Medical Research of Boynton Beach- Site Number : 8400116

Boynton Beach, Florida, 33436, United States

RECRUITING

Driven Research- Site Number : 8400135

Coral Gables, Florida, 33134, United States

RECRUITING

HealthMed Clinical Center- Site Number : 8400071

Coral Gables, Florida, 33134, United States

RECRUITING

Universal Medical Research - Coral Gables- Site Number : 8400081

Coral Gables, Florida, 33134, United States

RECRUITING

Genomics Medical Research- Site Number : 8400120

Cutler Bay, Florida, 33157, United States

RECRUITING

Direct Helpers Research Center- Site Number : 8400118

Hialeah, Florida, 33012, United States

RECRUITING

Zenith Clinical Research- Site Number : 8400127

Hollywood, Florida, 33021, United States

RECRUITING

Encore Medical Research - Hollywood- Site Number : 8400122

Hollywood, Florida, 33024, United States

RECRUITING

Universal Medical and Research Center- Site Number : 8400079

Homestead, Florida, 33030, United States

RECRUITING

Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

Jacksonville, Florida, 32216, United States

RECRUITING

K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063

Lady Lake, Florida, 32159, United States

RECRUITING

Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106

Miami, Florida, 33126, United States

RECRUITING

SouthCoast Research Center- Site Number : 8400114

Miami, Florida, 33136, United States

RECRUITING

Advanced Medical Research Institute - Miami- Site Number : 8400100

Miami, Florida, 33174, United States

RECRUITING

Health and Life Research Institute- Site Number : 8400070

Miami, Florida, 33176, United States

RECRUITING

WellQuest Clinical- Site Number : 8400082

Miami, Florida, 33176, United States

RECRUITING

Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021

Ocala, Florida, 34470, United States

RECRUITING

Leading Edge Dermatology- Site Number : 8400077

Plantation, Florida, 33317, United States

RECRUITING

Nuline Clinical Trial Center- Site Number : 8400060

Pompano Beach, Florida, 33060, United States

RECRUITING

D&H Tamarac Research Center- Site Number : 8400121

Tamarac, Florida, 33321, United States

RECRUITING

TrueBlue Clinical Research- Site Number : 8400016

Tampa, Florida, 33609, United States

RECRUITING

Optimum Clinical Trial Group- Site Number : 8400125

Tampa, Florida, 33612, United States

RECRUITING

CenExel FCR Tampa- Site Number : 8400130

Tampa, Florida, 33613, United States

RECRUITING

Accel Research Sites - NeuroStudies- Site Number : 8400134

Decatur, Georgia, 30030, United States

RECRUITING

MetroMed Clinical Trials- Site Number : 8400054

Chicago, Illinois, 60614, United States

RECRUITING

AMR Chicago- Site Number : 8400019

Oak Brook, Illinois, 60523, United States

RECRUITING

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031

Skokie, Illinois, 60077, United States

RECRUITING

Dawes Fretzin Clinical Research- Site Number : 8400022

Indianapolis, Indiana, 46256, United States

RECRUITING

Accellacare - McFarland Clinic- Site Number : 8400045

Ames, Iowa, 50010, United States

RECRUITING

The Iowa Clinic West Des Moines Campus- Site Number : 8400084

West Des Moines, Iowa, 50266, United States

RECRUITING

Equity Medical - Bowling Green- Site Number : 8400093

Bowling Green, Kentucky, 42104, United States

RECRUITING

Louisiana Dermatology Associates- Site Number : 8400043

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Clinical Trials Management - Metairie- Site Number : 8400072

Metairie, Louisiana, 70006, United States

RECRUITING

DelRicht Research - New Orleans 308- Site Number : 8400013

New Orleans, Louisiana, 70115, United States

RECRUITING

Private Practice - Dr. Lawrence J. Green- Site Number : 8400024

Rockville, Maryland, 20850, United States

RECRUITING

MetroBoston Clinical Partners - Brighton- Site Number : 8400008

Brighton, Massachusetts, 02135, United States

RECRUITING

Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

Marlborough, Massachusetts, 01752, United States

RECRUITING

Michigan Institute of Research- Site Number : 8400092

Allen Park, Michigan, 48101, United States

RECRUITING

Vida Clinical Studies - Dearborn Heights- Site Number : 8400074

Dearborn Heights, Michigan, 48127, United States

RECRUITING

Clinical Research Institute - Minneapolis- Site Number : 8400080

Minneapolis, Minnesota, 55402, United States

RECRUITING

MediSearch Clinical Trials- Site Number : 8400035

Saint Joseph, Missouri, 64506, United States

RECRUITING

Boeson Research - Missoula- Site Number : 8400069

Missoula, Montana, 59804, United States

RECRUITING

Las Vegas Clinical Trials- Site Number : 8400056

Las Vegas, Nevada, 89030, United States

RECRUITING

Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104

Wilmington, North Carolina, 28403, United States

RECRUITING

Lynn Institute of Oklahoma City- Site Number : 8400004

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Best Skin Research - Camp Hill- Site Number : 8400017

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

DelRicht Research - Thompson's Station- Site Number : 8400041

Smyrna, Tennessee, 37167, United States

RECRUITING

Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115

Baytown, Texas, 77521, United States

RECRUITING

DFW Clinical Trials- Site Number : 8400057

Carrollton, Texas, 75010, United States

RECRUITING

Modern Research Associates- Site Number : 8400094

Dallas, Texas, 75231, United States

RECRUITING

Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002

Houston, Texas, 77004, United States

RECRUITING

Lone Star Clinical Research - Katy- Site Number : 8400049

Katy, Texas, 77450, United States

RECRUITING

DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046

Prosper, Texas, 75078, United States

RECRUITING

Cope Family Medicine - Ogden Clinic- Site Number : 8400112

Bountiful, Utah, 84010, United States

RECRUITING

Alpine Research Association- Site Number : 8400050

Layton, Utah, 84041, United States

RECRUITING

CenExel JRB - Salth Lake City- Site Number : 8400128

Salt Lake City, Utah, 84107, United States

RECRUITING

Springville Dermatology - Springville- Site Number : 8400113

Springville, Utah, 84663, United States

RECRUITING

The Education & Research Foundation- Site Number : 8400036

Lynchburg, Virginia, 24501, United States

RECRUITING

Seattle Clinical Research Center- Site Number : 8400038

Seattle, Washington, 98104, United States

RECRUITING

Investigational Site Number : 0360001

Phillip, Australian Capital Territory, 2606, Australia

RECRUITING

Investigational Site Number : 0360008

Kotara, New South Wales, 2289, Australia

RECRUITING

Investigational Site Number : 0360003

Sydney, New South Wales, 2010, Australia

RECRUITING

Investigational Site Number : 0360006

Waitara, New South Wales, 2077, Australia

RECRUITING

Investigational Site Number : 0360005

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Investigational Site Number : 0360007

Carlton, Victoria, 3053, Australia

RECRUITING

Investigational Site Number : 0360002

Melbourne, Victoria, 3004, Australia

RECRUITING

Investigational Site Number : 0360009

Melbourne, Victoria, 3124, Australia

RECRUITING

Investigational Site Number : 1240006

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

Investigational Site Number : 1240001

Barrie, Ontario, L4M 7G1, Canada

RECRUITING

Investigational Site Number : 1240004

Toronto, Ontario, M4E 1R7, Canada

RECRUITING

Investigational Site Number : 1240009

Montreal, Quebec, H1Y 3L1, Canada

RECRUITING

Investigational Site Number : 1240007

Québec, Quebec, G1W 4R4, Canada

RECRUITING

Investigational Site Number : 1240008

Sherbrooke, Quebec, J1G 1X9, Canada

RECRUITING

Related Links

• VBE00001 Plain Language Results Summary

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Core Study: Sentinel Cohorts: modified double-blind * Investigators, participants, laboratory personnel will be blinded. * Clinical site staff preparing/administering the study vaccines will be unblinded. * Sponsor study staff involved in ESDRs will be unblinded at the time of the ESDR. Main Cohorts: modified double-blind * Investigators, participants, laboratory personnel and Sponsor study staff will be blinded. * Only clinical site staff preparing/administering the study vaccines will be unblinded. * Sponsor staff involved in the Internal Firewall Committee will be unblinded at the time of interim analyses. Long-Term Extension: Sentinel Cohorts and Main Cohorts: double-blind * Investigators, participants, laboratory personnel and Sponsor study staff will be blinded. * Sponsor staff involved in the Internal Firewall Committee will be unblinded at the time of interim analyses.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: April 5, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (79); AU (8); CA (6)