Acne mRNA vaccine
BiologicalPharmaceutical form: suspension for injection Route of administration: intramuscular
NCT Number: NCT07013747
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1 / Phase 2
Encino Research Center- Site Number : 8400008, Encino, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Pharmaceutical form: liquid solution for injection Route of administration: intramuscular
Time frame: In 30 minutes after each administration
Time frame: Up to 7 days after each administration
pre-listed in the participant diary [PDi] and in the case report form [CRF]
Time frame: Up to 28 days after each administration
Time frame: Up to 6 months after each administration
Time frame: Up to 6 months after each administration
Time frame: Up to 6 months after each administration
Presence of all SAEs
Time frame: Through 7 days after administration (Day 08)
Presence of out-of-range biological test results (including shift from baseline values)
Time frame: At 2 months post last administration
Time frame: At 2 months post last administration
Time frame: Up to 38 months after first administration
Presence of all SAEs and AESIs
Time frame: From baseline (Day 01) to 6 months post last administration
Time frame: At 1 month post first administration to 6 months post last administration
Time frame: At 1 month post first administration to 6 months post last administration
Time frame: At 1 month post first administration to 6 months post last administration
Time frame: At 1 month post first administration to 6 months post last administration
Time frame: In 30 minutes after each administration
Time frame: Up to 7 days after each administration
pre-listed in the participant diary [PDi] and in the case report form [CRF]
Time frame: Up to 28 days after each administration
Time frame: Up to 6 months after each administration
Time frame: Up to 6 months after each administration
Time frame: Up to 6 months after each administration
Presence of all SAEs
Time frame: Through 7 days after administration (Day 08)
Presence of out-of-range biological test results (including shift from baseline values)
Contact information is provided by the study sponsor or research team.
Sanofi Pasteur, a Sanofi Company
Industry
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
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.
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