Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India

Expert Rev Vaccines. 2023 Jan-Dec;22(1):278-287. doi: 10.1080/14760584.2023.2188942.

Abstract

Background: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap).

Research design and methods: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment.

Results: No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination.

Conclusions: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.

Keywords: Acellular pertussis; booster; diphtheria; tetanus; vaccine.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Bacterial
  • Child
  • Diphtheria Toxoid
  • Diphtheria* / prevention & control
  • Diphtheria-Tetanus-acellular Pertussis Vaccines*
  • Humans
  • Immunization, Secondary / methods
  • Pertussis Vaccine
  • Tetanus Toxoid
  • Tetanus* / prevention & control
  • Toxoids
  • Whooping Cough* / prevention & control

Substances

  • Tetanus Toxoid
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Diphtheria Toxoid
  • Pertussis Vaccine
  • Toxoids
  • Antibodies, Bacterial

Associated data

  • CTRI/CTRI/2018/06/014617