Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

August 30, 2024 updated by: Sanofi Pasteur, a Sanofi Company

A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years

VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The duration of participation will be approximately 6 months for each participant.

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sanofi Trial Transparency Email Recommended (Toll free for US and Canada
  • Phone Number: Opt. 6 800-633-1610
  • Email: contact-us@saonofi.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 60 to 75 years on the day of inclusion
  • A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 RSV/hMPV dose A1
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A1
Suspension for injection. Route of administration: IM injection
Experimental: Group 2 RSV/hMPV dose A2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A2
Suspension for injection. Route of administration: IM injection
Experimental: Group 3 RSV/hMPV dose A3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose A3
Suspension for injection. Route of administration: IM injection
Experimental: Group 4 RSV/hMPV dose B1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B1
Suspension for injection. Route of administration: IM injection
Experimental: Group 5 RSV/hMPV dose B2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B2
Suspension for injection. Route of administration: IM injection
Experimental: Group 6 RSV/hMPV dose B3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose B3
Suspension for injection. Route of administration: IM injection
Experimental: Group 7 RSV/hMPV dose C1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C1
Suspension for injection. Route of administration: IM injection
Experimental: Group 8 RSV/hMPV dose C2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C2
Suspension for injection. Route of administration: IM injection
Experimental: Group 9 RSV/hMPV dose C3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose C3
Suspension for injection. Route of administration: IM injection
Experimental: Group 10 RSV/hMPV dose 1
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 1
Suspension for injection. Route of administration: IM injection
Experimental: Group 11 RSV/hMPV dose 2
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 2
Suspension for injection. Route of administration: IM injection
Experimental: Group 12 RSV/hMPV dose 3
Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.
Biological: RSV/hMPV vaccine dose 3
Suspension for injection. Route of administration: IM injection
Experimental: Group 13 Monovalent RSV Vaccine
Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.
Biological: Monovalent RSV Vaccine
Suspension for injection. Route of administration: IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Time Frame: On Day 1
On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Time Frame: Day 1 through day 8
Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
Time Frame: Day 1 through day 29
Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
Time Frame: SAE: Screening through day 181; AESI: Day 1 through day 181
SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Time Frame: Screening through day 8
Screening through day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
Time Frame: At day 1 and day 29
At day 1 and day 29
hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1 and day 28
At day 1 and day 28
RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181
hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Time Frame: At day 1, day 29, day 91, and day 181
At day 1, day 29, day 91, and day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 23, 2024

Primary Completion (Estimated)

July 14, 2025

Study Completion (Estimated)

July 14, 2025

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAV00039
  • U1111-1308-3615 (Other Identifier: WHO UTN)

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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