PCV15, a pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in infants and children

ABSTRACT

Introduction

Streptococcus pneumoniae is a causative agent of pneumonia and acute otitis media (AOM), as well as invasive diseases such as meningitis and bacteremia. PCV15 (V114) is a new 15-valent pneumococcal conjugate vaccine (PCV) approved for use in individuals ≥6 weeks of age for the prevention of pneumonia, AOM, and invasive pneumococcal disease.

Areas Covered

This review summarizes the V114 Phase 3 development program leading to approval in infants and children, including pivotal studies, interchangeability and catch-up vaccination studies, and studies in at-risk populations. An integrated safety summary is presented in addition to immunogenicity and concomitant use of V114 with other routine pediatric vaccines.

Expert Opinion

Across the development program, V114 demonstrated a safety profile that is comparable to PCV13 in infants and children. Immunogenicity of V114 is comparable to PCV13 for all shared serotypes except serotype 3, where V114 demonstrated superior immunogenicity. Higher immune responses were demonstrated for V114 serotypes 22F and 33F. Results of the ongoing study to evaluate V114 efficacy against vaccine-type pneumococcal AOM and anticipated real-world evidence studies will support assessment of vaccine effectiveness and impact, with an additional question of whether higher serotype 3 immunogenicity translates to better protection against serotype 3 pneumococcal disease.

KEYWORDS:

• Immunogenicity
• PCV15
• pediatric
• phase 3
• pneumococcal conjugate vaccine
• pneumonia
• safety
• VAXNEUVANCE

Article highlights

• PCV15 (V114) is a 15-valent pneumococcal conjugate vaccine approved in infants, children, and adults for the prevention of pneumonia, AOM, and invasive pneumococcal disease

• This review summarizes the V114 pediatric phase 3 clinical program that included trials in healthy infants and children as well individuals with at-risk conditions, using 2 + 1 and 3 + 1 immunization schedules

• V114 was well tolerated in all studies, with a safety profile similar to the active comparator PCV13

• V114 demonstrated non-inferior immunogenicity to PCV13 for the 13 shared serotypes, and superior immunogenicity for shared serotype 3 and V114 serotypes 22F and 33F

• With a strong safety and immunogenicity profile in infants and children, V114 is expected to maintain protection offered by PCV13 while further reducing pneumococcal disease against additional epidemiologically important serotypes

Declaration of interest

T.J. Chapman, A.M. Houston, G. Tamms, R. Lupinacci, K Feemster, U.K. Buchwald, and N. Banniettis are employees of MSD and may hold stock in Merck & Co., Inc., Rahway, NJ, U.S.A.. L.O. received investigator-initiated grants from Merck Investigator Studies Program and was an investigator on pneumococcal vaccine clinical trials sponsored by Merck, Pfizer, and Sanofi; research funds for all these activities were provided to her institution. G. Dbaibo received honoraria from MSD, Pfizer, Sanofi, and Abbott for speaking engagements and Advisory Board memberships, as well as research grants paid to the institution from Pfizer and Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript apart from those disclosed.

Reviewer disclosures

A peer reviewer on this manuscript is an employee of GSK. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Author contributions

All authors contributed to the conception, design, or planning and/or the interpretation of the results and drafting of the manuscript. All authors critically reviewed or revised the manuscript for important intellectual content, approved the final manuscript as submitted, and agreed to be accountable for all aspects of the work.

Acknowledgments

We would like to acknowledge all the study participants and their families, study staff, and investigators who contributed to the V114 pediatric program. Editorial support was provided by Karyn Davis (MSD).

Additional information

Funding

This work was supported by MSD.