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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

PHASE1RECRUITING

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.

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Study details:

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

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 60 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-09

Primary completion: 2025-08-27

Study completion finish: 2025-08-27

Study type

PREVENTION

Phase

PHASE1

Trial ID

NCT06583031

Intervention or treatment

BIOLOGICAL: RSV/hMPV vaccine dose A1

BIOLOGICAL: RSV/hMPV vaccine dose A2

BIOLOGICAL: RSV/hMPV vaccine dose A3

BIOLOGICAL: RSV/hMPV vaccine dose B1

BIOLOGICAL: RSV/hMPV vaccine dose B2

BIOLOGICAL: RSV/hMPV vaccine dose B3

BIOLOGICAL: RSV/hMPV vaccine dose C1

BIOLOGICAL: RSV/hMPV vaccine dose C2

BIOLOGICAL: RSV/hMPV vaccine dose C3

BIOLOGICAL: RSV/hMPV vaccine dose 1

BIOLOGICAL: RSV/hMPV vaccine dose 2

BIOLOGICAL: RSV/hMPV vaccine dose 3

BIOLOGICAL: Monovalent RSV Vaccine

Conditions

• RSV Infection
• hMPV

Condition: RSV Infection, hMPV
BIOLOGICAL: RSV/hMPV vaccine dose A1 and other drugs
Brookvale, New South Wales, Australia and more
Sponsor: Sanofi Pasteur, a Sanofi Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Site # 031001

Research sites nearby

Select from list below to view details:

Site # 031001
Brookvale, New South Wales, Australia
Site # 0361002
Wollongong, New South Wales, Australia
Site # 0361003
Herston, Queensland, Australia

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?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination	Not Specified	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	Not Specified	Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination	Not Specified	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	Not Specified	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	Not Specified	Screening through day 8

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants	Not Specified	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	Not Specified	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	Not Specified	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	Not Specified	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	Not Specified	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	Not Specified	At day 1, day 29, day 91, and day 181

Frequently Asked Questions

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References

Clinical Trials Gov: 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