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
Phase 1
Active, not recruiting
- Conditions
- RSV InfectionhMPV
- Interventions
- Biological: RSV/hMPV vaccine dose A1Biological: RSV/hMPV vaccine dose A3Biological: RSV/hMPV vaccine dose A2Biological: RSV/hMPV vaccine dose B1Biological: RSV/hMPV vaccine dose B2Biological: RSV/hMPV vaccine dose B3Biological: RSV/hMPV vaccine dose C1Biological: RSV/hMPV vaccine dose C2Biological: RSV/hMPV vaccine dose C3Biological: RSV/hMPV vaccine dose 1Biological: RSV/hMPV vaccine dose 2Biological: RSV/hMPV vaccine dose 3Biological: Monovalent RSV Vaccine
- Registration Number
- NCT06583031
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 385
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 RSV/hMPV dose A1 RSV/hMPV vaccine dose A1 Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 3 RSV/hMPV dose A3 RSV/hMPV vaccine dose A3 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 2 RSV/hMPV dose A2 RSV/hMPV vaccine dose A2 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 4 RSV/hMPV dose B1 RSV/hMPV vaccine dose B1 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 5 RSV/hMPV dose B2 RSV/hMPV vaccine dose B2 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 6 RSV/hMPV dose B3 RSV/hMPV vaccine dose B3 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 7 RSV/hMPV dose C1 RSV/hMPV vaccine dose C1 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 8 RSV/hMPV dose C2 RSV/hMPV vaccine dose C2 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 9 RSV/hMPV dose C3 RSV/hMPV vaccine dose C3 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 10 RSV/hMPV dose 1 RSV/hMPV vaccine dose 1 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 11 RSV/hMPV dose 2 RSV/hMPV vaccine dose 2 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 12 RSV/hMPV dose 3 RSV/hMPV vaccine dose 3 Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule. Group 13 Monovalent RSV Vaccine Monovalent RSV Vaccine Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (6)
Site # 0361004
🇦🇺Botany, New South Wales, Australia
Site # 031001
🇦🇺Brookvale, New South Wales, Australia
Site # 0361006
🇦🇺Miranda, New South Wales, Australia
Site # 0361002
🇦🇺Wollongong, New South Wales, Australia
Site # 0361003
🇦🇺Herston, Queensland, Australia
Site # 0361005
🇦🇺South Brisbane, Queensland, Australia