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 three 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 a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens 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.
Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no safe and effective treatment that can prevent and cure this disease. The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at three different dose levels in adults aged 18 to 45 years with moderate to severe acne. The results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
260
Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular
Center for Dermatology and Plastic Surgery- Site Number : 8400111
Scottsdale, Arizona, United States
RECRUITINGPrivate Practice - Dr. Francisco Badar- Site Number : 8400067
Cerritos, California, United States
RECRUITINGEncino Research Center- Site Number : 8400033
Encino, California, United States
RECRUITINGParadigm Clinical Research Centers- Site Number : 8400064
La Mesa, California, United States
Core Study - Sentinel Cohort A and B: Number of participants with unsolicited systemic AEs
Presence of unsolicited systemic adverse events (AEs) reported
Time frame: 30 minutes after each administration
Core Study - Sentinel Cohort 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 \[CRF\])
Time frame: Up to 7 days after each administration
Core Study - Sentinel Cohort A and B: Number of participants with unsolicited AEs
Time frame: Up to 28 days after each administration
Core Study - Sentinel Cohort A and B: Number of participants with MAAEs
Presence of medically attended adverse events (MAAEs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort A and B: Number of participants with SAEs
Presence of all serious adverse events (SAEs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort A and B: Number of participants with AESIs
Presence of AEs of special interest (AESIs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Time frame: Through 7 days after administration (Day 8)
Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time frame: At 2 months post last administration
Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time frame: At 2 months post last administration
Long-Term Extension - Sentinel Cohort 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)
Time frame: Up to 38 months after first administration
Core Study - Sentinel Cohort A, B and Main Cohort: Vaccine-antigen-specific serum antibody titers
Time frame: From baseline (Day 1) to 6 months post last administration
Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time frame: At1 month post first administration until 6 months post last administration
Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Time frame: At 1 month post first administration until 6 months post last administration
Core Study - Main Cohort: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time frame: At 1 month post first administration until 6 months post last administration
Core Study - Main Cohort: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Time frame: At 1 month post first administration until 6 months post last administration
Core Study - Main Cohort: Absolute change from baseline in IGA score
Time frame: At 1 month post first administration until 6 months post last administration
Core Study - Main Cohort: Number of participants with unsolicited systemic AEs
Presence of unsolicited systemic adverse events (AEs) reported
Time frame: 30 minutes after each administration
Core Study - Main Cohort: 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 \[CRF\])
Time frame: Up to 7 days after each administration
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Sunwise Clinical Research- Site Number : 8400108
Lafayette, California, United States
RECRUITINGChemidox Clinical Trials- Site Number : 8400075
Lancaster, California, United States
RECRUITINGKaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
Los Angeles, California, United States
RECRUITINGLA Universal Research Center- Site Number : 8400059
Los Angeles, California, United States
RECRUITINGAlliance Clinical - West Hills- Site Number : 8400131
Los Angeles, California, United States
RECRUITINGCarbon Health - North Hollywood - NoHo West- Site Number : 8400076
North Hollywood, California, United States
RECRUITING...and 83 more locations
Core Study - Main Cohort: Number of participants with unsolicited AEs
Time frame: Up to 28 days after each administration
Core Study - Main Cohort: Number of participants with MAAEs
Presence of medically attended adverse events (MAAEs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort: Number of participants with SAEs
Presence of all serious adverse events (SAEs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort: Number of participants with AESIs
Presence of AEs of special interest (AESIs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort: Number of participants with out-of-range biological test results (including shift from baseline values)
Time frame: Through 7 days after administration (Day 8)