VAX-24 / Vaxcyte - LARVOL DELTA

Application of Network Meta-Analysis in Vaccine Research: An Illustration Using Immunogenicity of Pneumococcal Vaccines in Adults (ISPOR-EU 2025) - "OBJECTIVES: A frequentist network meta-analysis (NMA) using data from clinical trials on pneumococcal vaccines (PnVx; licensed/under development) for adult (aged ≥50 years) immunisation was conducted to provide an overview of PnVx's immunogenicity performance against serotype 3 (ST3), associated with substantial disease burden in Europe. An NMA was performed to describe the immunogenicity of PnVx in terms of opsonophagocytic activity (functional) titres against ST3 including immunogenicity data on 8 PnVx (pneumococcal conjugate vaccines [PCV20, PCV13, PCV15, V116, Vax-24, Vax-31], 23-valent pneumococcal polysaccharide vaccine [PPSV23], and 24-valent MAPS technology-based PnVx [Pn-MAPS24v]) evaluated in 9 trials (phase 1/2, phase 2, and phase 3). The application of NMA in vaccine research may provide considerable benefit to researchers and decision-makers by supporting a detailed understanding of the relative immunogenicity induced by different vaccines, integrating..."

Pneumococcal vaccines • Retrospective data • Infectious Disease • Pneumococcal Infections • Pneumonia

Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants (clinicaltrials.gov) - P2 | N=802 | Completed | Sponsor: Vaxcyte, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pediatrics • Pneumococcal Infections

A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older. (PubMed, Vaccine) - P2 | "Healthy adults aged 65 or older were randomized in a 1:1:1:1 ratio to receive a single injection of VAX-24 at 1 of 3 dose levels (1.1, 2.2, or a mixed dose of 2.2 or 4.4 mcg) or Prevnar 20® (PCV20) in a phase 2, blinded study. The outcome of this phase 2 study further supports use of VAX-24 2.2 mcg dose in phase 3 trials. Clinicaltrials.gov: NCT05297578."

Clinical • Journal • P2 data • Infectious Disease • Pneumococcal Infections

CELL FREE PROTEIN SYNTHESIS PLATFORM TO EXPAND PNEUMOCOCCAL SEROTYPE COVERAGE AND INCREASE IMMUNE RESPONSE – CLINICAL DATA (ISPPD 2024) - "Methods Clinical data include a total of 1042 pneumococcal vaccine naïve adults from two clinical trials that have received VAX-24 in 1.1 mcg, 2.2 mcg, and 2.2/4.4 mcg doses or Prevnar 20 (PCV20) as active comparator. Robust opsonophagocytosis assay (OPA) and IgG responses were demonstrated to all 24 serotypes, with the 2.2 mcg dose providing an optimized polysaccharide/carrier protein presentation resulting in an increased average immune response across serotypes relative to PCV20. Conclusions VAX-24 had a safety profile similar to PCV20 and induced robust OPA and IgG responses to all 24 serotypes, supporting the hypothesis that site-specific conjugation allows for broader serotype coverage with higher immune response and lower carrier suppression."

Clinical data • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants (clinicaltrials.gov) - P2 | N=802 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pediatrics • Pneumococcal Infections

Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. (PubMed, Lancet Infect Dis) - P1/2 | "VAX-24 had a safety profile similar to PCV20 at all doses, with the 2·2 μg dose showing increased serotype coverage with decreased carrier suppression."

Journal • P1/2 data • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Vaxcyte, Inc.

New P2 trial • Infectious Disease • Pediatrics • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults (clinicaltrials.gov) - P2 | N=207 | Completed | Sponsor: Vaxcyte, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Feb 2023 | Trial primary completion date: Jun 2023 ➔ Feb 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults (clinicaltrials.gov) - P1/2 | N=771 | Completed | Sponsor: Vaxcyte, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections

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Novel Coronavirus Disease

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults (clinicaltrials.gov) - P2 | N=207 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Vaxcyte, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults (clinicaltrials.gov) - P1/2 | N=864 | Active, not recruiting | Sponsor: Vaxcyte, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal Infections