hMPV, RSV Infection
Conditions
Keywords
RSV, RSV Infection, RSV Vaccine, hMPV, hMPV Infection, hMPV Vaccine
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.
Interventions
BIOLOGICALRSV/hMPV vaccine dose A1
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose A2
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose A3
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose B1
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose B2
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose B3
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose C1
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose C2
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose C3
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose 1
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose 2
Suspension for injection. Route of administration: IM injection
BIOLOGICALRSV/hMPV vaccine dose 3
Suspension for injection. Route of administration: IM injection
BIOLOGICALMonovalent RSV Vaccine
Suspension for injection. Route of administration: IM injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Modified double-blinded for the sentinel and main cohorts. * Blinding for vaccine group assignment: participants, outcome assessors, Investigators, laboratory personnel (for both sentinel and main cohort); Sponsor study staff (except biostatistician) and Sponsor SMT (Safety Management Team) for main cohort * No blinding for vaccine group assignment: those preparing and administering the study interventions; Sponsor study staff and Sponsor SMT for sentinel cohorts
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 |
Countries
Australia
Outcome results
None listed