Clinical studies
CAPVAXIVE was studied in a robust Phase 3 clinical trial program
Across four Phase 3 trials (Studies 1-4), CAPVAXIVE was studied in a broad range of >6500 vaccine-naïve and vaccine-experienced adults of varying ages, risk factorsa for pneumococcal disease, races, and/or ethnic groups.
CAPVAXIVE demonstrated strong immunogenicity
Study 1: Immunogenicity of CAPVAXIVE in pneumococcal vaccine-naïve adults vs PCV20
- In individuals 50 years of age and older, CAPVAXIVE was non-inferior to PCV20 for the 10 serotypes common to both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F)
- In individuals 50 years of age and older, CAPVAXIVE was superior to PCV20 for 10 of 11 serotypes included in CAPVAXIVE but not in PCV20 (9N, 15A, 16F, 17, 20A, 23A, 23B, 24F, 31, 35B)
- Immune responses were observed for serotype 15C in participants 50 years of age and older receiving CAPVAXIVE, but did not meet criteria for statistical superiority
- 64.7% of individuals 50 years and older who received CAPVAXIVE had ≥4-fold rise in cross-reactive OPA titers for serotype 15B
- The OPA responses of individuals 18 through 49 years of age to each of 22 S. pneumoniae serotypes met the criteria for immunobridging when compared to the OPA responses of individuals 50 through 64 years of age
Study design
Study 1 was a randomized double-blind Phase 3 study to assess the immunogenicity of CAPVAXIVE compared to PCV20 in pneumococcal vaccine-naïve individuals. Participants 50 years of age and older (n=2362) were enrolled in cohort 1, and participants 18 through 49 years of age (n=301) were enrolled in cohort 2. For cohort 1, the primary endpoints of the study included serotype specific OPA GMTs 1 month postvaccination and percentage of participants with ≥4-fold rise in serotype specific OPA responses from baseline to 1 month postvaccination. For cohort 2, a conclusion of immunobridging was based on the lower bound of the 2-sided 95% confidence interval for the estimated GMT ratio (18-49 years/50-64 years) being >0.5.1
There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.
Study 3: Immunogenicity of CAPVAXIVE in pneumococcal vaccine-experienced adults
- In individuals who previously received PPSV23, CAPVAXIVE elicited OPA responses that were comparable to PCV15 for the 6 common serotypes (3, 6A, 7F, 19A, 22F, 33F), and higher OPA responses for the 15 unique serotypes (8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B) and serotype 15B
- In individuals who previously received PCV13, CAPVAXIVE elicited OPA responses comparable to PPSV23 for the 12 common serotypes (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F) and serotype 15B, and higher OPA responses for the 9 unique serotypes (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B)
- OPA responses to CAPVAXIVE were similar across the 3 cohorts of participants who previously received one or more pneumococcal vaccines
Study design
Study 3 was a descriptive Phase 3 study that enrolled vaccine-experienced individuals 50 years and older who received a pneumococcal vaccine at least 1 year prior to enrollment (n=717). Study 3 included three cohorts. For cohort 1, individuals who previously received PPSV23 were randomized to receive CAPVAXIVE (n=231) or PCV15 (n=119). For cohort 2, individuals who previously received PCV13 were randomized to receive either CAPVAXIVE (n=176) or PPSV23 (n=85). For cohort 3, individuals who received other prior pneumococcal vaccines (PCV13 + PPSV23, PCV15 + PPSV23, PPSV23 + PCV13 or PCV15) were allocated to receive CAPVAXIVE (n=106). In each of the 3 cohorts, serotype-specific OPA GMTs and the proportion of individuals with ≥4-fold rise in OPA responses from baseline to 1-month postvaccination were assessed.
CAPVAXIVE can be coadministered with the influenza vaccine
Study 4: CAPVAXIVE with influenza vaccine coadministration
The OPA responses to CAPVAXIVE administered concomitantly with quadrivalent influenza vaccine were non-inferior to the OPA responses to CAPVAXIVE administered sequentially after influenza vaccine for 20 of 21 serotypes contained in CAPVAXIVE (serotype 23B did not meet non-inferiority criterion). The OPA response to serotype 15B was not assessed for non-inferiority. Influenza vaccine administered concomitantly with CAPVAXIVE was non-inferior to influenza vaccine administered alone as assessed by influenza strain-specific HAI responses for 3 of 4 influenza strains (strain A/H3N2 did not meet non-inferiority criterion).
Study design
Study 4 was a double-blind study that enrolled 1080 individuals 50 years of age and older, with or without a history of prior pneumococcal vaccination, who were randomized in a 1:1 ratio. One vaccination group received CAPVAXIVE and the quadrivalent influenza vaccine concomitantly, followed by placebo 30 days later (concomitant group). A second vaccination group received the influenza vaccine and placebo concomitantly followed by CAPVAXIVE 30 days later (sequential group). Primary endpoints of the study were CAPVAXIVE serotype-specific OPA GMT (concomitant group/sequential group) and influenza strain-specific HAI GMTs at 1 month postvcaccination (concomitant group/sequential group).
Across the four Phase 3 clinical trials for CAPVAXIVE, ~63% of adults included were 50 years of age and older1
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aApproximately 34% of vaccinated individuals had one or more prespecified chronic medical conditions known to increase the risk of pneumococcal disease (ie, diabetes, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma, smoking, alcoholism).
GMTs, geometric mean titers; HAI, hemagglutination inhibition; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine; PCV15, 15-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine.
Reference:
- Platt H. V116: An investigational adult specific pneumococcal conjugate vaccine: key results from the phase 3 clinical development program. Slide deck presented at: Advisory Committee for Immunization Practices Meeting; February 28-29, 2024; virtual.