This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.
The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups).
The duration of the study will be approximately 12 months for each participant.
Aged 60 years or older on the day of inclusion
Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
Previous history of myocarditis, pericarditis, and/or myopericarditis
Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
Parallel
RSV+HMPV vaccine
Biological/VaccineRSV + HMPV Candidate Vaccine
Control Vaccine 3
Biological/VaccineControl Vaccine 3
Control Vaccine 4
Biological/VaccineControl Vaccine 4
Control Vaccine 2
Biological/VaccineControl Vaccine 2
Placebo
Other interventionPlacebo
Control Vaccine 1
Biological/VaccineControl Vaccine 1
11
Treatment groupsSee each treatment group below.
RSV A serum nAb (neutralizing antibodies) titers
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers
nAb titers expressed as GMTs
HMPV A serum nAb titers
nAb titers expressed as GMTs
HMPV B serum nAb titers
nAb titers expressed as GMTs
RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination
nAb titers expressed as GMTs
