A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age). Study Objectives: Primary: * To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations. Secondary: * To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations * To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant
A total of 150 subjects will be allocated to 7 cohorts. Subjects will be randomly assigned to vaccine treatment or saline placebo in a 4:1 ratio, such that each cohort will include 20 subjects who receive active vaccine (Groups A, B, C, D, F and G) and 5 subjects who receive placebo (Group E). Subjects will be followed for all AEs, including SAEs and non-serious AEs, from the time of each vaccination through 30 days following the second vaccination (Day 60±5). After Day 60, subjects will be contacted via telephone on a monthly basis (approximately Days 90, 120, 150, 180, and 210) and asked about the occurrence of SAEs and SNMCs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Dose 1 + adjuvant / dose; Day 0 and Day 30
Dose 2 + adjuvant / dose; Day 0 and Day 30
Dose 3 + adjuvant / dose; Day 0 and Day 30
Dose 3 / dose; Day 0 and Day 30
Placebo; Day 0 and Day 30
Dose 4 / dose; Day 0 and Day 30
Dose 4 + adjuvant / dose; Day 0 and Day 30
Healthcare Discoveries d/b/a ICON Development Solutions
San Antonio, Texas, United States
To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.
This primary outcome will be evaluated through an assessment of the following parameters: * Immediate AEs * Solicited AEs * All SAEs and SNMCs * Vital signs * Laboratory Assessments
Time frame: Day 60 (2 months)
To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations
This secondary outcome will be assessed in the following manner: * Neutralizing antibody against RSV measured in a PRNT assay * Total anti-F IgG measured by ELISA by ELISA
Time frame: Day 60 (2 months)
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