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Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

Anil Narang1, Anuradha Bose, Anand Nilkanth Pandit

  • 1Post-Graduate Institute of Medical Education and Research, Chandigarh, India.

Human Vaccines
|March 12, 2009
PubMed

Insights

Two doses of the oral rotavirus vaccine RIX4414 (Rotarix()) demonstrated strong immunogenicity and a favorable safety profile in Indian infants. This live-attenuated vaccine is well-tolerated and effective in this population.

Area of Science:

  • Pediatric infectious diseases
  • Vaccinology
  • Immunology

Background:

  • Rotavirus is a leading cause of severe diarrheal disease in infants globally.
  • Developing effective vaccines is crucial for reducing rotavirus-related morbidity and mortality.
  • The RIX4414 (Rotarix()) oral live-attenuated vaccine has shown promise in clinical trials.

Purpose of the Study:

  • To evaluate the immunogenicity of two doses of RIX4414 (Rotarix()) in Indian infants.
  • To assess the reactogenicity and safety of the RIX4414 vaccine in the study population.
  • To compare the immune response and safety of RIX4414 against a placebo.

Main Methods:

  • A randomized, placebo-controlled trial involving 363 healthy infants aged approximately eight weeks.
  • Participants received two doses of RIX4414 vaccine or placebo, one month apart.
  • Immune response was measured by seroconversion rates one month post-dose 2; safety and reactogenicity were monitored throughout the study.

Main Results:

  • The seroconversion rate in the RIX4414 group was 58.3%, significantly higher than the 6.3% in the placebo group.
  • The vaccine demonstrated a favorable safety profile, with similar reactogenicity and adverse events between the vaccine and placebo groups.
  • RIX4414 was well-tolerated by the healthy Indian infants.

Conclusions:

  • Two doses of RIX4414 (Rotarix()) are immunogenic in healthy Indian infants.
  • The vaccine exhibits a good safety profile and is well-tolerated.
  • RIX4414 represents a potentially valuable tool for rotavirus prevention in India.
Abstract

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