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Immunogenicity and safety of an indigenously developed DTPw hepatitis B combination vaccine in Indian infants

Raju Shah1, M B Raghu, A Shivananda

  • 1Department of Pediatrics, Shardaben General Hospital and Smt NHL Municipal Medical College, Ahmedabad, India. rajucshah@gmail.com

Indian Pediatrics
|October 25, 2008
PubMed

Insights

This study found the indigenous Shantetra vaccine (diphtheria, tetanus, pertussis, and hepatitis B) to be safe and effective in Indian infants. It demonstrated high seroprotective immune responses comparable to Tritanrix HB, with similar mild adverse events.

Area of Science:

  • Pediatric Vaccinology
  • Immunology
  • Infectious Disease Prevention

Background:

  • Hepatitis B, diphtheria, tetanus, and B. pertussis (pertussis) infections pose significant health risks to infants.
  • Effective vaccination strategies are crucial for preventing these diseases in early childhood.
  • Indigenous vaccine development is vital for public health accessibility and sustainability.

Purpose of the Study:

  • To assess the safety and immunogenicity of an indigenous tetravalent vaccine (Shantetra) against hepatitis B, diphtheria, tetanus, and B. pertussis.
  • To compare the efficacy of Shantetra with a licensed comparator vaccine (Tritanrix HBTM) in Indian infants.

Main Methods:

  • A multicentric, randomized, single-blind, intention-to-treat study was conducted across five tertiary care centers in India.
  • 151 healthy Indian infants were randomized (2:1) to receive either Shantetra or Tritanrix HBTM.
  • Humoral immune response, specifically seroconversion rates for each antigenic component, was monitored post-vaccination.

Main Results:

  • Shantetra demonstrated high seroprotective rates: 98.9% for diphtheria, tetanus, and hepatitis B components.
  • Anti-pertussis antibody response was robust, observed in 89% of infants receiving Shantetra.
  • Common adverse events, including injection site pain, mild fever, and transient crying, were similar in both vaccine groups.

Conclusions:

  • The indigenously developed DTPw-Hepatitis B combination vaccine (Shantetra) is safe and immunogenic in healthy Indian infants.
  • Shantetra provides comparable seroprotective immune responses to the comparator vaccine.
  • This study supports the use of indigenously developed vaccines for national immunization programs.
Abstract

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