Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Respiratory Syncytial Virus Infection; Human Metapneumovirus
• Intervention / Treatment: Biological: RSV/hMPV vaccine candidate Dose L; Biological: RSV/hMPV vaccine candidate Dose A; Biological: RSV/hMPV vaccine candidate Dose B; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• Puerto Rico
  • Guayama, Puerto Rico, 000784
    • Recruiting
    • Investigational Site Number : 6300002
  • San Juan, Puerto Rico, 00909
    • Recruiting
    • Investigational Site Number : 6300001
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Investigational Site Number : 6300003
• United States
  • California
    • Los Angeles, California, United States, 90057
      • Recruiting
      • Matrix Clinical Research Site Number : 8400011
    • Rolling Hills Estates, California, United States, 90274
      • Recruiting
      • Peninsula Research Associates Site Number : 8400001
  • Florida
    • Miami, Florida, United States, 33173
      • Recruiting
      • Suncoast Research Associates, LLC Site Number : 8400002
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Recruiting
      • Velocity Clinical Research, Sioux City Site Number : 8400012
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Recruiting
      • AMR Lexington Site Number : 8400008
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Recruiting
      • AMR Kansas City Site Number : 8400014
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • Recruiting
      • AMR Knoxville Site Number : 8400010
  • Texas
    • Tomball, Texas, United States, 77375
      • Recruiting
      • DM Clinical Research - Tomball Site Number : 8400004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sentinel Cohort: RSV/hMPV Group 0 (Dose L); Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate	Biological: RSV/hMPV vaccine candidate Dose L; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: Sentinel Cohort: RSV/hMPV Group 1 (Dose A); Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate	Biological: RSV/hMPV vaccine candidate Dose A; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: Sentinel Cohort: RSV/hMPV Group 2 (Dose B); Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate	Biological: RSV/hMPV vaccine candidate Dose B; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Placebo Comparator: Sentinel Cohort: Placebo-Group 3; Participants will be randomized to receive a single IM injection of placebo	Biological: Placebo; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: Main Cohort: RSV/hMPV Group 1 (Dose A); Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate	Biological: RSV/hMPV vaccine candidate Dose A; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: Main Cohort: RSV/hMPV Group 2 (Dose B); Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate	Biological: RSV/hMPV vaccine candidate Dose B; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Placebo Comparator: Main Cohort: Placebo-Group 3; Participants will be randomized to receive a single IM injection of placebo	Biological: Placebo; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Experimental: Booster Cohort-RSV/hMPV; Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort	Biological: RSV/hMPV vaccine candidate Dose A; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection; Biological: RSV/hMPV vaccine candidate Dose B; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Placebo Comparator: Booster Cohort-Placebo; Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort	Biological: Placebo; Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of unsolicited AEs	Number of participants experiencing unsolicited AEs	Within 28 days after vaccination
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
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
Presence of medically attended adverse events (MAAEs)	Number of participants experiencing MAAEs	Up to 6 months after primary injection
Presence of serious adverse events (SAEs)	Number of participants experiencing SAEs	Up to 6 months after primary injection
Presence of adverse events of special interest (AESIs)	Number of participants experiencing AESIs	Up to 6 months after primary injection
Presence of related SAEs	Number of participants experiencing related SAEs	Throughout study (approximately 24 months)
Presence of related AESIs	Number of participants experiencing related AESIs	Throughout study (approximately 24 months)
Presence of fatal SAEs	Number of participants experiencing fatal SAEs	Throughout study (approximately 24 months)
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): March 10, 2026
• Study Completion (Estimated): March 10, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VBD00003; U1111-1287-8547 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No