Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Phase 2RecruitingNCT07734649

Sanofi2,400 enrolled

Overview

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

2,400

Conditions

Respiratory Syncytial Virus Immunization Human Metapneumovirus Immunization Healthy Volunteers

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 60 years or older on the day of inclusion * Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile) Exclusion Criteria: * History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months * Previous history of myocarditis, pericarditis, and/or myopericarditis * Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Previous history of Guillain-Barré Syndrome * Any vaccine given 4 weeks before or 4 weeks after study intervention * Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine * Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration * Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months * Any screening laboratory parameter with laboratory abnormality \> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (17)

Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025

Gadsden, Alabama, United States

RECRUITING

Scottsdale Clinical Trials- Site Number : 8400011

Scottsdale, Arizona, United States

RECRUITING

Long Beach Research Institute- Site Number : 8400005

Long Beach, California, United States

RECRUITING

Alliance Clinical - San Diego- Site Number : 8400033

San Diego, California, United States

RECRUITING

Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064

DeLand, Florida, United States

RECRUITING

Accel Research Sites - NeuroStudies- Site Number : 8400063

Decatur, Georgia, United States

RECRUITING

DM Clinical Research - Chicago- Site Number : 8400050

Melrose Park, Illinois, United States

RECRUITING

DM Clinical Research - Detroit- Site Number : 8400049

Southfield, Michigan, United States

RECRUITING

Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016

Lincoln, Nebraska, United States

RECRUITING

Alliance Clinical - Las Vegas- Site Number : 8400034

Las Vegas, Nevada, United States

RECRUITING

...and 7 more locations

Outcomes

Primary Outcomes

RSV A serum nAb (neutralizing antibodies) titers

nAb titers expressed as geometric mean titers (GMTs)

Time frame: At Day 1 and Day 29

RSV B serum nAb titers

nAb titers expressed as GMTs

Time frame: At Day 1 and Day 29

HMPV A serum nAb titers

nAb titers expressed as GMTs

Time frame: At Day 1 and Day 29

HMPV B serum nAb titers

nAb titers expressed as GMTs

Time frame: At Day 1 and Day 29

Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination

Number of participants reporting immediate unsolicited systemic AEs

Time frame: Within 30 minutes after vaccination

Presence of solicited injection site and systemic reactions

Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue and myalgia

Time frame: For 8 days, including the day of vaccination

Presence of Unsolicited AEs

Number of participants reporting unsolicited AEs

Time frame: For 28 days, including day of vaccination

Presence of medically attended AEs (MAAEs)

Number of participants reporting MAAEs

Time frame: Within 6 months after vaccination

Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)

Number of participants reporting SAEs, fatal SAEs and AESIs

Time frame: Throughout the study (approximately 12 months)

Presence of out-of-range biological test results

Number of participants with biological safety assessment values out of normal range (including shift from baseline values)

Time frame: At Day 09

Secondary Outcomes

RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

nAb titers expressed as geometric mean titers (GMTs)

Time frame: 3, 6, 9, and 12-months post-vaccination

RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

nAb titers expressed as GMTs

Time frame: 3, 6, 9, and 12 months post-vaccination

HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

nAb titers expressed as GMTs

Time frame: 3, 6, 9, and 12 months post-vaccination

HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

nAb titers expressed as GMTs

Time frame: 3, 6, 9, and 12 months post-vaccination

Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

Ab concentration expressed as geometric mean concentrations (GMCs)

Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

Ab concentration expressed as GMCs

Time frame: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)

Time frame: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Overview

Conditions

Interventions

Eligibility

Locations (17)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts