Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial

ABSTRACT

Streptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) on natural exposure or revaccination has been shown to protect against community-acquired pneumonia and invasive pneumococcal disease in adults 65 years of age and older. An unconjugated 23-valent pneumococcal polysaccharide vaccine has been available for decades; however, data on protection against pneumonia are inconsistent. For the first time, a multicenter study has been conducted in India to assess the safety and immunogenicity of a single dose of PCV13 in adults aged 50 to 65 years. In this study, PCV13 elicited robust immune responses against all 13 pneumococcal serotypes as reflected by the magnitude of geometric mean fold rises (range, 6.6–102.7) in functional antibody levels from before to 1 month after vaccination. No serious adverse events occurred. These clinical trial findings support the safety and immunogenicity of PCV13 when administered to adults in India and indicate that a single dose of PCV13 has the potential to protect against vaccine-type pneumococcal disease in adults aged 50 to 65 years. ClinicalTrials.gov identifier: NCT02034877

KEYWORDS:

• adults
• India
• immunogenicity
• safety
• thirteen-valent pneumococcal conjugate vaccine

Disclosure of potential conflicts of interest

C Juergens, N Le Dren-Narayanin, MW Cutler, WC Gruber, DA Scott, and B Schmoele-Thoma are employees of Pfizer Inc. and may have stock or stock options. V Sundaraiyer is an employee of a Pfizer-contracted company. BB Solanki, MB Chopada, and P Supe received research support from Pfizer Inc.

Acknowledgments

The authors thank the B1851140 study group and the participants of this study. The authors thank Dr Canna Ghia and Dr Gautam Rambhad of Pfizer Global Vaccines for their input on epidemiologic data for India. Editorial support was provided by Tricia Newell, PhD, of Complete Healthcare Communications, LLC (Chadds Ford, PA). This work was funded by Pfizer Inc.

All authors participated in the preparation of this article and were involved in collecting and interpreting the data, drafting the article, or critically revising the article for important intellectual content. All authors gave final approval of the version to be submitted.