This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
Research Site AU004
Sydney, New South Wales, Australia
Research Site AU005
Herston, Queensland, Australia
Research Site AU002
Adelaide, South Australia, Australia
Research Site AU006
Prahran, Victoria, Australia
Resarch Site AU001
Nedlands, Western Australia, Australia
Neutralizing antibody titers to at least one RSV/A strain
Time frame: Day 0, 21, 28
Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.
Time frame: Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
Time frame: Day 0, 21, 28, 56, 119, 385
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Time frame: Day 0, 21, 28, 56, 119, 385
Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
Time frame: Day 0, 7, 28
Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-γ, or TNF-α production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.
Time frame: Day 0, 7, 28
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