RECRUITING

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

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Conditions

Acne

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age

Quick Facts

Study Start:2024-04-05
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06316297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
  2. * Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)
  1. * 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)
  2. * Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol \[PEG\], polysorbate); 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
  3. * Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
  4. * Use of any acne-affecting treatment without an appropriate washout period
  5. * Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
  6. * Previous vaccination against C. acnes with an investigational vaccine
  7. * Receipt of immune globulins, blood or blood-derived products in the past 3 months
  8. * Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com

Study Locations (Sites)

Core Healthcare Group- Site Number : 8400067
Cerritos, California, 90703
United States
Encino Research Center- Site Number : 8400033
Encino, California, 91436
United States
Paradigm Clinical Research Centers- Site Number : 8400064
La Mesa, California, 91942
United States
Chemidox Clinical Trials- Site Number : 8400075
Lancaster, California, 93534
United States
Kaiser Permanente Los Angeles- Site Number : 8400058
Los Angeles, California, 90027-5814
United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
North Hollywood, California, 91606
United States
Northridge Clinical Trials- Site Number : 8400053
Northridge, California, 91325
United States
Cura Clinical Research - Oxnard- Site Number : 8400062
Oxnard, California, 93030
United States
Empire Clinical Research - Pomona- Site Number : 8400055
Pomona, California, 91767
United States
Peninsula Research Associates- Site Number : 8400102
Rolling Hills Estates, California, 90274
United States
California Research Foundation- Site Number : 8400095
San Diego, California, 92123-1881
United States
NorthBay Clinical Research- Site Number : 8400066
Santa Rosa, California, 95405
United States
Unison Clinical Trials- Site Number : 8400025
Sherman Oaks, California, 91403
United States
Driven Research- Site Number : 8400135
Coral Gables, Florida, 33134
United States
Universal Medical Research-Coral Gables Office- Site Number : 8400081
Coral Gables, Florida, 33134
United States
Genomics Medical Research, LLC- Site Number : 8400120
Cutler Bay, Florida, 33321
United States
Zenith Clinical Research ,LLC- Site Number : 8400127
Hollywood, Florida, 33021
United States
Universal Medical Research- Site Number : 8400079
Homestead, Florida, 33030
United States
Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, 32216
United States
SouthCoast Research Center, Inc- Site Number : 8400114
Miami, Florida, 33136
United States
Health and Life Research Institute, LLC- Site Number : 8400070
Miami, Florida, 33176
United States
Wellquest Clinical Research Clinic- Site Number : 8400082
Miami, Florida, 33176
United States
SCLA Management, LLC- Site Number : 8400077
Plantation, Florida, 33317
United States
True Blue Clinical Research- Site Number : 8400016
Tampa, Florida, 33609
United States
AMR - Chicago- Site Number : 8400019
Oak Brook, Illinois, 60532
United States
Dawes Fretzin Clinical Research Group, LLC- Site Number : 8400022
Indianapolis, Indiana, 46256
United States
Accellacare - McFarland Clinic- Site Number : 8400045
Ames, Iowa, 50010
United States
Louisiana Dermatology Associates LLC, DelRicht Research at LA Dermatology Associates- Site Number : 8400043
Baton Rouge, Louisiana, 70809
United States
Clinical Trials Management, LLC- Site Number : 8400072
Metairie, Louisiana, 70006
United States
DelRicht Research - New Orleans 308- Site Number : 8400013
New Orleans, Louisiana, 70115
United States
Metro Boston Clinical Partners- Site Number : 8400008
Brighton, Massachusetts, 02135
United States
Michigan Institute of Research- Site Number : 8400092
Allen Park, Michigan, 48101-2009
United States
Vida Clinical Studies- Site Number : 8400074
Dearborn Heights, Michigan, 48127-2234
United States
Clinical Research Institute- Site Number : 8400080
Minneapolis, Minnesota, 55402
United States
MediSearch Clinical Trials (Dermatology)- Site Number : 8400035
Saint Joseph, Missouri, 64506
United States
Boeson Research - Site Number : 8400069
Missoula, Montana, 59804
United States
Las Vegas Clinical Trials- Site Number : 8400056
Las Vegas, Nevada, 89030
United States
Trial Management Associates, LLC- Site Number : 8400104
Wilmington, North Carolina, 28403
United States
Lynn Health Science Institute (LHSI)- Site Number : 8400004
Oklahoma City, Oklahoma, 73112
United States
Best Skin Research, LLC- Site Number : 8400017
Camp Hill, Pennsylvania, 17011
United States
DelRicht Research at MT. Pleasant Dermatology- Site Number : 8400047
Charleston, South Carolina, 29464
United States
DelRicht Research at Harpeth Valley Dermatology- Site Number : 8400041
Smyrna, Tennessee, 37167
United States
Center for Clinical Studies, LTD. LLP- Site Number : 8400002
Houston, Texas, 77004
United States
Lone Star Clinical Research - Site Number : 8400049
Katy, Texas, 77450
United States
DelRicht Research at Lockhart Matter Dermatology- Site Number : 8400046
Prosper, Texas, 75078
United States
Cenexel JBR- Site Number : 8400128
Salt Lake City, Utah, 84107
United States
The Education & Research Foundation- Site Number : 8400036
Forest, Virginia, 24551
United States
Seattle Clinical Research Center- Site Number : 8400038
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Sanofi Pasteur, a Sanofi Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-05
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-04-05
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acne