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Recruiting NCT07013747

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

Phase I / Phase II Interventional Acne

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acne mRNA vaccine, Placebo.
Who it may be relevant to
Registry conditions: Acne. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Biological Acne mRNA vaccine
    Pharmaceutical form: suspension for injection Route of administration: intramuscular
  • Other Placebo
    Pharmaceutical form: liquid solution for injection Route of administration: intramuscular

Primary outcome measures

  • 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]
  • 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]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported [Time frame: Up to 28 days after each administration]
  • 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]
  • 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]
  • Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) [Time frame: Up to 6 months after each administration]
  • 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)]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported [Time frame: Up to 28 days after each administration]
  • 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]
  • 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]
  • Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) [Time frame: Up to 6 months after each administration]
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Encino Research Center- Site Number : 8400008 — Encino
  • Moore Clinical Research - Brandon- Site Number : 8400007 — Brandon
  • Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006 — Jacksonville
  • DelRicht Research- Site Number : 8400003 — New Orleans

Identifiers

NCT: NCT07013747 · VBE00009 · 2025-520677-39 · U1111-1315-4645

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗