Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate

NCT06134648 | Completed Phase 1 FDA Drug

• 2 other identifiers: VBD00003U1111-1287-8547
• Study Type: interventional
• Target: 646
• Locations: 2 countries
• Sites: 13

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.

Conditions

Respiratory Syncytial Virus Infection; Healthy Volunteers; Human Metapneumovirus

Outcome Measures

Primary Outcomes (12)

• 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 unsolicited AEs

  Number of participants experiencing unsolicited AEs

  Within 28 days after 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 Outcomes (13)

• RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)

  Day 1 and Day 29

• RSV-B 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)

  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

  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

  Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12

Study Arms (9)

Sentinel Cohort: RSV/hMPV Group 0 (Dose L)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Biological: RSV/hMPV vaccine candidate Dose L

Sentinel Cohort: RSV/hMPV Group 1 (Dose A)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Biological: RSV/hMPV vaccine candidate Dose A

Sentinel Cohort: RSV/hMPV Group 2 (Dose B)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Biological: RSV/hMPV vaccine candidate Dose B

Sentinel Cohort: Placebo-Group 3

PLACEBO COMPARATOR

Participants will be randomized to receive a single IM injection of placebo

Biological: Placebo

Main Cohort: RSV/hMPV Group 1 (Dose A)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Biological: RSV/hMPV vaccine candidate Dose A

Main Cohort: RSV/hMPV Group 2 (Dose B)

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate

Biological: RSV/hMPV vaccine candidate Dose B

Main Cohort: Placebo-Group 3

PLACEBO COMPARATOR

Participants will be randomized to receive a single IM injection of placebo

Biological: Placebo

Booster Cohort-RSV/hMPV

EXPERIMENTAL

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; Biological: RSV/hMPV vaccine candidate Dose B

Booster Cohort-Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort

Biological: Placebo

Interventions

RSV/hMPV vaccine candidate Dose L BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Sentinel Cohort: RSV/hMPV Group 0 (Dose L)

RSV/hMPV vaccine candidate Dose A BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Booster Cohort-RSV/hMPV; Main Cohort: RSV/hMPV Group 1 (Dose A); Sentinel Cohort: RSV/hMPV Group 1 (Dose A)

RSV/hMPV vaccine candidate Dose B BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Booster Cohort-RSV/hMPV; Main Cohort: RSV/hMPV Group 2 (Dose B); Sentinel Cohort: RSV/hMPV Group 2 (Dose B)

Placebo BIOLOGICAL

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Booster Cohort-Placebo; Main Cohort: Placebo-Group 3; Sentinel Cohort: Placebo-Group 3

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (13)

Collaborative Neuroscience Research Site Number : 8400017

Los Alamitos, California, 90720, United States

Location

Matrix Clinical Research Site Number : 8400011

Los Angeles, California, 90057, United States

Location

Peninsula Research Associates Site Number : 8400001

Rolling Hills Estates, California, 90274, United States

Location

Suncoast Research Associates, LLC Site Number : 8400002

Miami, Florida, 33173, United States

Location

AMR Chicago, Oakbrook Terrace Site Number : 8400019

Oakbrook Terrace, Illinois, 60181, United States

Location

Velocity Clinical Research, Sioux City Site Number : 8400012

Sioux City, Iowa, 51106, United States

Location

AMR Lexington Site Number : 8400008

Lexington, Kentucky, 40509, United States

Location

AMR Kansas City Site Number : 8400014

Kansas City, Missouri, 64114, United States

Location

AMR Knoxville Site Number : 8400010

Knoxville, Tennessee, 37919, United States

Location

DM Clinical Research - Tomball Site Number : 8400004

Tomball, Texas, 77375, United States

Location

Investigational Site Number : 6300002

Guayama, 000784, Puerto Rico

Location

Investigational Site Number : 6300001

San Juan, 00909, Puerto Rico

Location

Investigational Site Number : 6300003

San Juan, 00918, Puerto Rico

Location

Related Links

• VBD00003 Plain Language Results Summaries

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sentinel, Main, and Booster Cohorts: observer-blind; for safety evaluation purposes, the Sponsor will be unblinded * Investigators, laboratory personnel, and participants will be blinded * Sponsor study staff and study staff preparing/administering the study interventions will be unblinded
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-escalation (Phase I, sentinel cohort), parallel (Phase IIa, main cohort), multi-center

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PR (3); US (10)