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

Acne Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316297
• Other study ID #: VBE00001
• Secondary ID: U1111-1295-3154
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 5, 2024
• Est. completion date: December 23, 2027

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US.

Description:

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 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 study is designed to assess the safety profile and efficacy (also long-term) of the vaccine candidate, select the dose for the further clinical development steps and to describe the immunogenicity profile of the vaccine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: December 23, 2027
• Est. primary completion date: December 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 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) 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 (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
• Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
• Use of any acne-affecting treatment without an appropriate washout period
• 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
• Previous vaccination against C. acnes with an investigational vaccine
• 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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Biological:
• Acne mRNA vaccine
Pharmaceutical form:Liquid suspension for injection-Route of administration:intramuscular

Other:
• Placebo
Pharmaceutical form:Liquid solution for injection-Route of administration:intramuscular

Locations

Country	Name	City	State
United States	Dermresearch Site Number : 8400009	Austin	Texas
United States	True Blue Clinical Research Site Number : 8400016	Brandon	Florida
United States	Metro Boston Clinical Partners Site Number : 8400008	Brighton	Massachusetts
United States	Center for Clinical Studies, LTD. LLP Site Number : 8400002	Houston	Texas
United States	Jacksonville Center for Clinical Research Site Number : 8400006	Jacksonville	Florida
United States	DelRicht Research Site Number : 8400013	New Orleans	Louisiana
United States	Lynn Health Science Institute (LHSI) Site Number : 8400004	Oklahoma City	Oklahoma
United States	DermResearch Center of New York, Inc Site Number : 8400010	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with unsolicited systemic AEs	Presence of unsolicited systemic adverse events (AEs) reported	30 minutes after each administration
Primary	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])	Up to 7 days after each administration
Primary	Number of participants with unsolicited AEs		Up to 28 days after each administration
Primary	Number of participants with MAAEs	Presence of medically attended adverse events (MAAEs)	Up to 6 months after each administration
Primary	Number of patients with SAEs	Presence of all serious adverse events (SAEs)	Up to 6 months after each administration
Primary	Number of patients with related SAEs, fatal SAEs and AESIs	Presence of related SAEs, fatal SAEs (regardless of causality) and AEs of special interest (AESIs)	Up to approximately 38 months
Primary	Change in grade from baseline in biological test results		Up to 7 days after each administration
Primary	Absolute change from baseline in the number of inflammatory acne lesions on face		3 and 6 months post last administration
Primary	Percentage change from baseline in the number of inflammatory acne lesions on face		3 and 6 months post last administration
Primary	Absolute change from baseline in the number of non-inflammatory acne lesions on face		3 and 6 months post last administration
Primary	Percentage change from baseline in the number of non-inflammatory acne lesions on face		3 and 6 months post last administration
Primary	At least two-grade improvement in IGA scores	At least two-grade improvement in IGA score from baseline (day 1) and post-administration IGA score of either 0 or 1	3 and 6 months post last administration
Secondary	Assessment of vaccine-antigen-specific serum antibody titers		At study day 1 and 28 days post last administration