PATH
Center for Vaccine Innovation and Access
Dr. Alderson is the Bacterial Vaccine Initiative Leader with PATH’s Center for Vaccine Innovation and Access, playing a lead role in the Pneumococcal Vaccine Project, Group B Streptococcal Vaccine Project and Meningococcal Vaccine Project, Polyvalent. These projects seek to accelerate the development and licensure of affordable vaccines and ensure their availability and use in low and middle income countries. Dr. Alderson led the PATH team that worked in close collaboration with the Serum Institute of India to develop, license and WHO prequalify the 10-valent pneumococcal conjugate vaccine, PNEUMOSIL, in 2019. Dr. Alderson has more than 30 years of experience in medical research, biotechnology, pharmaceuticals and vaccine development. Prior to PATH, Dr. Alderson was Director of Immunology at GlaxoSmithKline Biologicals, Seattle, where he led preclinical work on synthetic adjuvants for a variety of vaccine targets. Prior to GSK, he was Senior Director of Immunology at Corixa Corporation where he was responsible for evaluation of adjuvants and vaccines for tuberculosis, Chlamydia and HSV. Dr. Alderson has published over 120 manuscripts in peer reviewed journals. Dr. Alderson earned his PhD in immunology at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia and his MBA at Seattle University.

Presenter of 1 Presentation

O064 - IMMUNOGENICITY AND SAFETY OF A 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV) ADMINISTERED AS A 2+1 SCHEDULE TO HEALTHY INFANTS IN THE GAMBIA (ID 859)

Session Type
Parallel Session
Date
Wed, 22.06.2022
Session Time
15:05 - 16:50
Room
Grand Ballroom Centre
Lecture Time
17:05 - 17:13

Abstract

Background

SIIPL-PCV (Pneumosil®) is a new, low-cost, WHO prequalified 10-valent PCV manufactured by the Serum Institute of India Pvt. Ltd. This study was designed to describe how SIIPL-PCV compares to the other two WHO prequalified PCVs: 10-valent pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV [Synflorix™], GlaxoSmithKline); and the 13-valent PCV (PCV13 [Prevenar 13®], Pfizer), when given as a 2+1 schedule.

Methods

Vaccines were administered in a 1:1:1 ratio to 660 infants at 6 and 14 weeks of age with the booster at 9 months. The primary immunogenicity objective, measured four weeks after the booster, was to compare the serotype-specific immunoglobulin G geometric mean concentrations (GMCs) generated by SIIPL-PCV with those generated by PHiD-CV and PCV13.

Results

For SIIPL-PCV compared to PHiD-CV, GMC ratios for the shared serotypes ranged from 0.64 (95% CI 0.52 to 0.79) for serotype 19F to 2.91 (95% CI 2.47 to 3.44) for serotype 1. For SIIPL-PCV compared to PCV13, GMC ratios ranged from 0.72 (95% CI 0.60 to 0.87) for serotype 19A to 1.44 (95% CI 1.23 to 1.69) for serotype 1. Sixteen (7.3%) infants experienced a mild or moderate systemic rash following vaccination with SIIPL-PCV compared to seven (3.2%) and six (2.7%) following PHiD-CV and PCV13, respectively. No other notable differences in solicited adverse event rates occurred.

Conclusions

SIIPL-PCV generates robust immune responses following administration to infants according to a 2+1 schedule. The serotype-specific immune responses are of the same order as those generated by PHiD-CV and PCV13 for which effectiveness data are available.

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