Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)
A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
220
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
Inventprise Clinical Site
Vancouver, British Columbia, Canada
Inventprise Clinical Site
Halifax, Nova Scotia, Canada
Inventprise Clinical Site
Truro, Nova Scotia, Canada
Inventprise Clinical Site
Saint-Louis, Quebec, Canada
Solicited Local Adverse Events (AEs)
Number and severity of solicited local AEs (redness, swelling, and pain at the injection site) by group
Time frame: 7 days post-vaccination (Day 8)
Solicited Systemic AEs
Number and severity of solicited systemic AEs within 7 days after vaccination by group
Time frame: 7 days post-vaccination (Day 8)
Unsolicited AEs
Number and severity of unsolicited AEs within 28 days after vaccination by group
Time frame: 28 days post-vaccination (Day 29)
Severe Adverse Events (SAEs)
Number of SAEs within 6 months after vaccination by group
Time frame: 6 months post-vaccination (Day 169)
Geometric Mean Concentration (GMC) of IgG by Timepoint and Group
Geometric mean concentrations (GMC) of serotype-specific IgG at Day 1 and Day 29 by group
Time frame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) of IgG GMC's by Timepoint and Group
Geometric Mean Fold Rise in serotype specific IgG GMC's from baseline (D1) to Day 29 after vaccination by group
Time frame: 28 days post-vaccination (Day 29)
Percentage of Participants Achieving a > 4-fold IgG Rise From Baseline to Day 29
Percentage of participants achieving a \> 4-fold IgG rise from baseline to Day 29 by treatment group
Time frame: 28 days post-vaccination (Day 29)
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20 valent pneumococcal conjugate vaccine
OPA Geometric Mean Concentration Titer (GMT)
Geometric mean titer of serotype-specific OPA antibodies by group and timepoint
Time frame: Baseline (Day 1) and 28 days post-vaccination (Day 29)
Geometric Mean Fold Rise (GMFR) in Serotype Specific OPA GMT's by Group
Geometric mean fold rise (GMFR) of serotype-specific OPA antibodies from baseline to 28 days post-vaccination by group
Time frame: From Baseline (Day 1) to 28 days post-vaccination (Day 29)