Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134648
• Other study ID #: VBD00003
• Secondary ID: U1111-1287-8547
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2023
• Est. completion date: March 10, 2026

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
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: March 10, 2026
• Est. primary completion date: March 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Human Metapneumovirus
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections

Intervention

Biological:
• RSV/hMPV vaccine candidate Dose L
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
• Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Locations

Country	Name	City	State
Puerto Rico	Investigational Site Number : 6300002	Guayama
Puerto Rico	Investigational Site Number : 6300001	San Juan
Puerto Rico	Investigational Site Number : 6300003	San Juan
United States	AMR Kansas City Site Number : 8400014	Kansas City	Missouri
United States	AMR Knoxville Site Number : 8400010	Knoxville	Tennessee
United States	AMR Lexington Site Number : 8400008	Lexington	Kentucky
United States	Collaborative Neuroscience Research Site Number : 8400017	Los Alamitos	California
United States	Matrix Clinical Research Site Number : 8400011	Los Angeles	California
United States	Suncoast Research Associates, LLC Site Number : 8400002	Miami	Florida
United States	AMR Chicago, Oakbrook Terrace Site Number : 8400019	Oakbrook Terrace	Illinois
United States	Peninsula Research Associates Site Number : 8400001	Rolling Hills Estates	California
United States	Velocity Clinical Research, Sioux City Site Number : 8400012	Sioux City	Iowa
United States	DM Clinical Research - Tomball Site Number : 8400004	Tomball	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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 primary 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 primary 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	Up to 6 months after primary injection
Primary	Presence of serious adverse events (SAEs)	Number of participants experiencing SAEs	Up to 6 months after primary injection
Primary	Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Up to 6 months after primary injection
Primary	Presence of related SAEs	Number of participants experiencing related SAEs	Throughout study (approximately 24 months)
Primary	Presence of related AESIs	Number of participants experiencing related AESIs	Throughout study (approximately 24 months)
Primary	Presence of fatal SAEs	Number of participants experiencing fatal SAEs	Throughout study (approximately 24 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- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)	RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)	Day 1 and Day 29
Primary	hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)	hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)	Day 1 and Day 29
Secondary	RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)	RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination	Day 1 and Day 29
Secondary	RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)	RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination	Day 1 and Day 29
Secondary	hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)	hMPV serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination	Day 1 and Day 29
Secondary	RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	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	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	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination	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, Month 3, Month 6, Month 9 and Month 12
Secondary	RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination	RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination	RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	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	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	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination	hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Secondary	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	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	Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12