A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1 study of IVT PCV-25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine. Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
65
25 valent pneumococcal conjugate vaccine
20 valent pneumococcal conjugate vaccine
Canadian Center for Vaccinology, IWK Health Centre
Halifax, Nova Scotia, Canada
Adult Safety: solicited local and systemic adverse events
Number and severity of solicited local and systemic adverse events (AEs)
Time frame: 7 days post-vaccination (Day 8)
Adult Safety: clinically significant hematological and biochemical measurements
Number, severity, and relatedness of clinically significant hematological and biochemical measurements
Time frame: 7 days post-vaccination (Day 8)
Adult Safety: unsolicited adverse events
Number, severity, and relatedness of all unsolicited AEs
Time frame: 28 days post-vaccination (Day 29)
Adult Safety: related serious adverse events
Number, severity, and relatedness of serious adverse events (SAEs)
Time frame: through 6 months post last vaccination (Day 169)
Adult Safety: newly diagnosed chronic medical conditions
Number of newly diagnosed chronic medical conditions
Time frame: through 6 months post last vaccination (Day 169)
Adult Immunogenicity: immunoglobulin G (IgG) geometric mean concentration (GMC)
Serotype-specific IgG GMCs
Time frame: 28 days post-vaccination (Day 29)
Adult Immunogenicity: Geometric Mean Fold Rise (GMFR)
Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific IgG GMCs
Time frame: 28 days post-vaccination (Day 29)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adult Immunogenicity: opsonophagocytosis assay (OPA) geometric mean titers (GMTs)
Serotype-specific OPA GMTs
Time frame: 28 days post-vaccination (Day 29)
Adult Immunogenicity: GMFR OPA GMTs
GMFR (from baseline) in serotype-specific OPA GMTs
Time frame: 28 days post-vaccination (Day 29)