Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07013747

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Encino Research Center- Site Number : 8400008, Encino, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 mild facial acne vulgaris with:
  • IGA score of mild (grade 2 on the 5-grade IGA scale) AND
  • between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
  • between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
  • no nodulocystic lesions (ie, nodules and cysts)

Exclusion criteria

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
  • Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
  • Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
  • Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
  • 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 patient's potential participation in a clinical trial.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions

    Time frame: Up to 7 days after each administration

    pre-listed in the participant diary [PDi] and in the case report form [CRF]

  3. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported

    Time frame: Up to 28 days after each administration

  4. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)

    Time frame: Up to 6 months after each administration

  5. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)

    Time frame: Up to 6 months after each administration

  6. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)

    Time frame: Up to 6 months after each administration

    Presence of all SAEs

  7. Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results

    Time frame: Through 7 days after administration (Day 08)

    Presence of out-of-range biological test results (including shift from baseline values)

  8. Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face

    Time frame: At 2 months post last administration

  9. Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face

    Time frame: At 2 months post last administration

  10. Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)

    Time frame: Up to 38 months after first administration

    Presence of all SAEs and AESIs

Secondary outcomes

  1. Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers

    Time frame: From baseline (Day 01) to 6 months post last administration

  2. Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face

    Time frame: At 1 month post first administration to 6 months post last administration

  3. Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face

    Time frame: At 1 month post first administration to 6 months post last administration

  4. Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face

    Time frame: At 1 month post first administration to 6 months post last administration

  5. Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face

    Time frame: At 1 month post first administration to 6 months post last administration

  6. Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)

    Time frame: In 30 minutes after each administration

  7. Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions

    Time frame: Up to 7 days after each administration

    pre-listed in the participant diary [PDi] and in the case report form [CRF]

  8. Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported

    Time frame: Up to 28 days after each administration

  9. Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)

    Time frame: Up to 6 months after each administration

  10. Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)

    Time frame: Up to 6 months after each administration

  11. Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)

    Time frame: Up to 6 months after each administration

    Presence of all SAEs

  12. Core Study - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results

    Time frame: Through 7 days after administration (Day 08)

    Presence of out-of-range biological test results (including shift from baseline values)

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 10, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.