Effect of reduced two-dose (1+1) schedule of 10 and 13-valent pneumococcal conjugate vaccines (SynflorixTM and Prevenar13TM)) on nasopharyngeal carriage and serotype-specific immune response in the first two years of life: Results from an open-labelled randomized controlled trial in Indian children

Anand Kawade, Girish Dayma, Aditi Apte, Nilima Telang, Meenakshi Satpute, Emma Pearce, Lucy Roalfe, Rakesh Patil, Yanyun Wang, Navideh Noori, Arun Gondhali, Sanjay Juvekar, Assaf P. Oron, Sonali Sanghavi, David Goldblatt, Ron Dagan, Ashish Bavdekar

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: This study aimed to assess the effect of a reduced dose regime (1 + 1) of PCV10 and PCV13 along with 3-dose regimes on pneumococcal vaccine-type (VT) carriage and immunogenicity in the first two years of life in PCV-naïve Indian children. Methods: A total of 805 healthy infants aged 6–8 weeks were randomised to 7 groups (n = 115). Six groups received SynflorixTM(PCV10) or Prevenar13TM(PCV13) in the following schedules: 3 + 0 (three primary at 6, 10, and 14 weeks); 2 + 1 (two primary 6 and 14 weeks with booster at 9 months; 1 + 1 (one primary at 14 weeks with booster at 9 months). The 7th group was a PCV-naïve control group. Nasopharyngeal swabs were collected at 6, 18 weeks, 9, 10, 15, and 18 months of age. Venous blood samples were collected at 18 weeks, 9, 10, and 18 months of age for assessment of sero-specific IgG antibodies. Additionally, functional activity using a serotype specific opsonophagocytic assay (OPA) was assessed at 10 and 18 months of age in a subset (20%) of participants. Results: All schedules of PCV13 showed significant 13VT carriage reduction in the second year of life as compared to control. At 15 months of age, PCV13 (1 + 1) showed 45 % reduction in 13VT-carriage compared to the control [OR = 0.55 (95% CI; 0.31–0.97), p= 0.038]. None of the PCV10 schedules showed significant reduction in 10VT carriage in the second year. Although not powered for these outcomes, at 18 months of age, 1 + 1 and 2 + 1 schedules of both vaccines demonstrated higher sero-responders for all serotypes, higher geometric mean concentrations (GMC) for all serotypes except 23F [with both vaccines], higher percent OPA responders and OPA geometric mean titres (GMT) compared to the 3 + 0 schedules for all serotypes. Conclusion: The reduced dose schedule (1 + 1) of PCV13 results in significant VT-carriage reduction in the second year of life. Immune protection provided by 1 + 1 schedules of PCV10 and PCV13 in the second year of life is comparable to WHO-recommended 3-dose schedules.

Original languageAmerican English
Pages (from-to)3066-3079
Number of pages14
JournalVaccine
Volume41
Issue number19
DOIs
StatePublished - 5 May 2023

Keywords

  • Pneumococcal carriage
  • Pneumococcal conjugate vaccines
  • Reduced dose regime
  • Serotype-specific antibodies

All Science Journal Classification (ASJC) codes

  • Public Health, Environmental and Occupational Health
  • General Immunology and Microbiology
  • Infectious Diseases
  • Molecular Medicine
  • General Veterinary

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