Study of the Safety and Immune Response of an Investigational mRNA Vaccine for the Prevention of Respiratory Syncytial Virus and/or Human Metapneumovirus in Participants Aged 18 to 49 Years and 60 Years and Older

NCT06237296 | Completed Phase 1 FDA Drug

• 2 other identifiers: VAV00027U1111-1295-2931
• Study Type: interventional
• Target: 558
• Locations: 2 countries
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity an investigational messenger ribonucleic acid (mRN)A vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV) in older adults. A single intramuscular (IM) injection of 3 to 4 different doses of the RSV/hMPV mRNA vaccine candidate formulated with 2 different lipid nanoparticles (LNP) will be administered to healthy participants aged 18 to 49 years and 60 years and older. Treatment:

• RSV/hMPV mRNA / LNP 1 at 3-4 different doses or,
• RSV/hMPV mRNA / LNP 2 at 3-4 difference doses or,
• RSV mRNA / LNP 1 at 1 dose or,
• hMPV mRNA / LNP 1 at 1 dose

Conditions

Respiratory Syncytial Virus Infection; Healthy Volunteers; Metapneumovirus Infection

Outcome Measures

Primary Outcomes (10)

• Presence of unsolicited systemic immediate adverse events (AEs)

  Number of participants experiencing immediate an immediate unsolicited systemic adverse event

  Within 30 minutes after 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 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

  Throughout study (up to approximately 6 months)

• Presence of serious adverse events (SAEs)

  Throughout study (up to approximately 6 months)

  Throughout study (up to approximately 6 months)

• Presence of adverse events of special interest (AESIs)

  Number of participants experiencing AESIs

  Throughout study (up to approximately 6 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- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations

  RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

  Day 1 and Day 29

• RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent RSV formulations

  RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

  Day 1 and Day 29

• hMPV- A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- vaccination (D29) in the RSV/hMPV and monovalent hMPV formulations

  hMPV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-vaccination

  Day 1 and Day 29

Secondary Outcomes (5)

• RSV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

  Day 1, Day 29, Day 91 and Day 181

• RSV B serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

  Day 1, Day 29, Day 91 and Day 181

• RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent RSV formulation

  Day 1, Day 29, Day 91 and Day 181

• hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations

  Day 1, Day 29, Day 91 and Day 181

• hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination in the monovalent hMPV formulations

  Day 1, Day 29, Day 91 and Day 181

Study Arms (7)

RSV/hMPV mRNA / LNP 1 Group 1

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 1.

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 2

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 2.

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 3

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 3.

Biological: RSV/hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 2 Group 4

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 2 dose 1.

Biological: RSV/hMPV mRNA LNP 2

RSV mRNA / LNP 1 Group 5

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV mRNA / LNP vaccine 1 dose 1.

Biological: RSV mRNA LNP 1

hMPV mRNA / LNP 1 Group 6

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of hMPV mRNA / LNP vaccine 1 dose 1.

Biological: hMPV mRNA LNP 1

RSV/hMPV mRNA / LNP 1 Group 7

EXPERIMENTAL

Participants will be randomized to receive a single IM injection of RSV/hMPV mRNA / LNP vaccine 1 dose 4.

Biological: RSV/hMPV mRNA LNP 1

Interventions

RSV/hMPV mRNA LNP 1 BIOLOGICAL

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

RSV/hMPV mRNA / LNP 1 Group 1; RSV/hMPV mRNA / LNP 1 Group 2; RSV/hMPV mRNA / LNP 1 Group 3; RSV/hMPV mRNA / LNP 1 Group 7

RSV/hMPV mRNA LNP 2 BIOLOGICAL

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

RSV/hMPV mRNA / LNP 2 Group 4

RSV mRNA LNP 1 BIOLOGICAL

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

RSV mRNA / LNP 1 Group 5

hMPV mRNA LNP 1 BIOLOGICAL

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

hMPV mRNA / LNP 1 Group 6

Eligibility Criteria

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

You may qualify if:

• Informed consent form (ICF) has been signed and dated

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (17)

Velocity Gardena Site Number : 8400011

Gardena, California, 90247, United States

Location

Velocity Clinical Research-Hallandale Beach- Site Number : 8400013

Hallandale, Florida, 33009, United States

Location

Advanced Clinical Research- Site Number : 8400005

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research, Sioux City Site Number : 8400017

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research- New Orleans Site Number : 8400016

New Orleans, Louisiana, 70119, United States

Location

Meridian Clinical Research- Site Number : 8400007

Binghamton, New York, 13905, United States

Location

Velocity Clinical Research- Site Number : 8400012

Cleveland, Ohio, 44122, United States

Location

Coastal Carolina Research Center- Site Number : 8400001

North Charleston, South Carolina, 29405, United States

Location

Charlottesville Medical Research Center Winding River - Site Number : 8400002

Charlottesville, Virginia, 22911, United States

Location

Investigational Site Number : 0360006

Blacktown, New South Wales, 2148, Australia

Location

Investigational Site Number : 0360002

Botany, New South Wales, 2019, Australia

Location

Investigational Site Number : 0360003

Kanwal, New South Wales, 2259, Australia

Location

Investigational Site Number : 0360004

Sydney, New South Wales, 2035, Australia

Location

Investigational Site Number : 0360008

Herston, Queensland, 4006, Australia

Location

Investigational Site Number : 0360005

Morayfield, Queensland, 4506, Australia

Location

Investigational Site Number : 0360001

Camberwell, Victoria, 3124, Australia

Location

Investigational Site Number : 0360007

Canberra, 2617, Australia

Location

Related Links

• VAV00027 Plain Language Results Summary

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: * Participants, Investigators and site staff remain blinded during study conduct, except dedicated study staff preparing/administering the study intervention. * Sponsor study staff will remain unblinded, except laboratory staff who handle primary/secondary endpoints
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: January 23, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (9); AU (8)