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
NCT Number: NCT06583031
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: RSV Infection|hMPV
Interventions: 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
Sponsor: Sanofi Pasteur, a Sanofi Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 390
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-23
Completion Date: 2025-07-14

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.

Primary Outcome Measures: Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination, 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, Day 1 through day 8|Presence of unsolicited AEs reported through 28 days after vaccination, 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, 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, Screening through day 8
Secondary Outcome Measures: RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants, 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, 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, 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, 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, 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, At day 1, day 29, day 91, and day 181