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NCT06237296 Clinical Trial

Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

Healthy Volunteers Clinical Trial

Official title:
A Phase I, Dose-escalation, Parallel-group, Randomized, Multi-center Study to Assess Safety and Immunogenicity of an RSV/hMPV mRNA Vaccine Candidate in Healthy Participants Aged 18 to 49 Years and 60 Years and Older.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06237296
Other study ID # VAV00027
Secondary ID VAV00027U1111-12
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 23, 2024
Est. completion date November 25, 2024

Study information
Verified date May 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
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment: - RSV/hMPV mRNA / LNP 1 at 3-4 different doses or, - RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or, - RSV mRNA / LNP 1 at 1 dose or, - hMPV mRNA / LNP 1 at 1 dose

Description:

Study duration per participant is approximately 6 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 545
Est. completion date November 25, 2024
Est. primary completion date November 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: -Informed consent form (ICF) has been signed and dated Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: -Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. --The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• RSV/hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• RSV/hMPV mRNA LNP 2
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• RSV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• hMPV mRNA LNP 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Locations
Country Name City State
Australia Investigational Site Number : 0360006 Blacktown New South Wales
Australia Investigational Site Number : 0360002 Botany New South Wales
Australia Investigational Site Number : 0360001 Camberwell Victoria
Australia Investigational Site Number : 0360007 Canberra
Australia Investigational Site Number : 0360008 Herston Queensland
Australia Investigational Site Number : 0360003 Kanwal New South Wales
Australia Investigational Site Number : 0360005 Morayfield Queensland
Australia Investigational Site Number : 0360004 Sydney New South Wales
United States Meridian Clinical Research Site Number : 8400007 Binghamton New York
United States Charlottesville Medical Research Center Winding River Site Number : 8400002 Charlottesville Virginia
United States Velocity Clinical Research Site Number : 8400012 Cleveland Ohio
United States Velocity Gardena Site Number : 8400011 Gardena California
United States Velocity Clinical Research-Hallandale Beach Site Number : 8400013 Hallandale Beach Florida
United States Advanced Clinical Research Site Number : 8400005 Meridian Idaho
United States Velocity Clinical Research Site Number : 8400016 New Orleans Louisiana
United States Coastal Carolina Research Center Site Number : 8400001 North Charleston South Carolina
United States Velocity Clinical Research, Sioux City Site Number : 8400017 Sioux City Iowa

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of unsolicited systemic immediate adverse events (AEs) Number of participants experiencing immediate an immediate unsolicited systemic adverse event Within 30 minutes after vaccination
Primary Presence of solicited injection site or systemic reactions Number of participants reporting:
injection site reactions: pain, erythema and swelling
systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills		 Within 7 days after vaccination
Primary Presence of unsolicited AEs Number of participants experiencing unsolicited AEs Within 28 days after vaccination
Primary Presence of medically attended adverse events (MAAEs) Number of participants experiencing MAAEs Throughout study (up to approximately 6 months)
Primary Presence of serious adverse events (SAEs) Throughout study (up to approximately 6 months) Throughout study (up to approximately 6 months)
Primary Presence of adverse events of special interest (AESIs) Number of participants experiencing AESIs Throughout study (up to approximately 6 months)
Primary Presence of out-of-range biological test results Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values) Within 7 days after vaccination
Primary RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination Day 1 and Day 29
Primary RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination Day 1 and Day 29
Primary hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination Day 1 and Day 29
Secondary RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination Day 1, Day 29, Day 91 and Day 181
Secondary RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination Day 1, Day 29, Day 91 and Day 181
Secondary RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination Day 1, Day 29, Day 91 and Day 181
Secondary hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination Day 1, Day 29, Day 91 and Day 181
Secondary hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination Day 1, Day 29, Day 91 and Day 181
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