Clinical trial NCT06134648: Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
Official title: A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus Infection
Healthy Volunteers
Human Metapneumovirus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 646
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose-escalation (Phase I, sentinel cohort), parallel (Phase IIa, main cohort), multi-center
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.

Detailed description: Study duration per participant:

12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.

Treatment Duration:

Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.

Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years or older on the day of inclusion
* A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.
* Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. Persons living with stable human immunodeficiency virus (HIV) are not excluded
* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, 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
* History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Screening electrocardiogram 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
* Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
* Receipt of anticoagulants in the 3 weeks preceding inclusion
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
* Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
* History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
* Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
* Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
* Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
* Receipt of immune globulins, blood, or blood-derived products in the past 3 months
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Presence of unsolicited systemic immediate adverse events (AEs)
timeFrame: Within 30 minutes after primary vaccination
measure: Presence of solicited injection site or systemic reactions
timeFrame: Within 7 days after primary vaccination
measure: Presence of unsolicited AEs
timeFrame: Within 28 days after vaccination
measure: Presence of medically attended adverse events (MAAEs)
timeFrame: Up to 6 months after primary injection
measure: Presence of serious adverse events (SAEs)
timeFrame: Up to 6 months after primary injection
measure: Presence of adverse events of special interest (AESIs)
timeFrame: Up to 6 months after primary injection
measure: Presence of related SAEs
timeFrame: Throughout study (approximately 24 months)
measure: Presence of related AESIs
timeFrame: Throughout study (approximately 24 months)
measure: Presence of fatal SAEs
timeFrame: Throughout study (approximately 24 months)
measure: Presence of out-of-range biological test results
timeFrame: Within 7 days after vaccination
measure: RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
timeFrame: Day 1 and Day 29
measure: hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
timeFrame: Day 1 and Day 29
Secondary outcomes:
measure: RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
timeFrame: Day 1 and Day 29
measure: RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
timeFrame: Day 1 and Day 29
measure: hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)
timeFrame: Day 1 and Day 29
measure: RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
measure: hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
timeFrame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research Site Number : 8400017
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research Site Number : 8400011
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Site Number : 8400001
state: California
city: Miami
country: United States
facility: Suncoast Research Associates, LLC Site Number : 8400002
state: Florida
city: Oakbrook Terrace
country: United States
facility: AMR Chicago, Oakbrook Terrace Site Number : 8400019
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City Site Number : 8400012
state: Iowa
city: Lexington
country: United States
facility: AMR Lexington Site Number : 8400008
state: Kentucky
city: Kansas City
country: United States
facility: AMR Kansas City Site Number : 8400014
state: Missouri
city: Knoxville
country: United States
facility: AMR Knoxville Site Number : 8400010
state: Tennessee
city: Tomball
country: United States
facility: DM Clinical Research - Tomball Site Number : 8400004
state: Texas
city: Guayama
country: Puerto Rico
facility: Investigational Site Number : 6300002
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300001
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300003
Study officials:
References: