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

Abstract

OBJECTIVE:

To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus and B. pertussis tetravalent vaccine (Shantetra) in comparison with Tritanrix HBTM in healthy Indian infants.

DESIGN:

Multicentric, randomized, single blind intention-to-treat study with 12-18 weeks of follow up period.

SETTING:

5 out patient departments at tertiary care referral centers across India.

PARTICIPANTS:

151 infants were randomized in a 2:1 ratio to recruit 101 in the Shantetra and 50 in the Tritanrix HBTM groups respectively. A total of 136 subjects completed the study. No patients were withdrawn from the study due to any adverse effects.

INTERVENTIONS:

Recruited subjects were randomized to receive three doses of either of the two DTPw-Hepatitis B combination vaccines as per the EPI schedule.

MAIN OUTCOME MEASURES:

Monitoring the humoral immune response (seroconversion rates) induced by each antigenic component three to six weeks after the last dose of vaccine in both the groups.

RESULTS:

Seroprotective immune response was observed in 98.9% subjects for diphtheria, tetanus and hepatitis B components in the Shantetra group as compared to 95.5% subjects in the Tritanrix HB group. Anti pertussis antibody response was seen in 89% and 91.1% in the Shantetra and Tritanrix HB groups, respectively. The commonly observed adverse events in both the groups were, pain at injection site, mild fever and transient crying.

CONCLUSION:

The safety and immunogenicity of indigenously developed DTPwHepatitis B combination vaccine was demonstrated in the present study.

• Authors: Raju Shah, M B Raghu, A Shivananda, S Mangayarkarasi, I Rao, R Rao, P Bhusari, C A Joseph, R Reddy
• Journal: Indian pediatrics (Indian Pediatr) Vol. 45 Issue 10 Pg. 819-23 (Oct 2008) ISSN: 0019-6061 [Print] India
• PMID: 18948651 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria-Tetanus-Pertussis Vaccine
• Hepatitis B Vaccines
• Tritanrix-HepB vaccine
• Vaccines, Combined

Topics

• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, immunology)
• Hepatitis B Vaccines (administration & dosage, immunology)
• Humans
• India
• Infant
• Single-Blind Method
• Vaccines, Combined