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

Conditions

• Acne

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Acne mRNA vaccine — BIOLOGICAL
  Pharmaceutical form: Liquid 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 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.

Key Dates

Start date

Apr 5, 2024

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Sentinel Cohort A - Experimental
  Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
• Placebo Comparator: Sentinel Cohort A - Placebo
  Two administrations of placebo will be injected
• Experimental: Sentinel Cohort B - Experimental
  Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
• Placebo Comparator: Sentinel Cohort B - Placebo
  Three administrations of placebo will be injected
• Experimental: Main Cohort A - Experimental
  Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
• Placebo Comparator: Main Cohort A - Placebo
  Two administrations of placebo will be injected
• Experimental: Main Cohort B - Experimental
  Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
• Placebo Comparator: Main Cohort B - Placebo
  Three administrations of placebo will be injected

Primary Outcome Measure

Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs [ Time Frame: 30 minutes after each administration ]

Central Contacts

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

Locations (79)

Find similar trials in Scottsdale, AZ

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