Clinical trial NCT06583031: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: RSV Infection
hMPV
Keywords: RSV
RSV Infection
RSV Vaccine
hMPV
hMPV Infection
hMPV Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 385
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
timeFrame: On Day 1
measure: 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
timeFrame: Day 1 through day 8
measure: Presence of unsolicited AEs reported through 28 days after vaccination
timeFrame: Day 1 through day 29
measure: Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
timeFrame: SAE: Screening through day 181; AESI: Day 1 through day 181
measure: Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
timeFrame: Screening through day 8
Secondary outcomes:
measure: RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
timeFrame: At day 1 and day 29
measure: hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
timeFrame: At day 1 and day 28
measure: RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
timeFrame: At day 1, day 29, day 91, and day 181
measure: 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
timeFrame: At day 1, day 29, day 91, and day 181
measure: 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
timeFrame: At day 1, day 29, day 91, and day 181
measure: 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
timeFrame: At day 1, day 29, day 91, and day 181
Other outcomes:
Locations:
city: Botany
country: Australia
facility: Site # 0361004
state: New South Wales
city: Brookvale
country: Australia
facility: Site # 031001
state: New South Wales
city: Miranda
country: Australia
facility: Site # 0361006
state: New South Wales
city: Wollongong
country: Australia
facility: Site # 0361002
state: New South Wales
city: Herston
country: Australia
facility: Site # 0361003
state: Queensland
city: South Brisbane
country: Australia
facility: Site # 0361005
state: Queensland
Study officials:
References: