Safety and immunogenicity of Haemophilus influenzae type B vaccine given in combination with DTwP at 6, 10 and 14 weeks of age.

Abstract

OBJECTIVE:

To assess the immunogenicity and reactogenicity of a tetanus conjugate Haemophilus influenzae type b vaccine (Act-Hib) when extemporaneously mixed and administered as a DTwP-Hib combination using an Indian DTwP vaccine (BE DTwP) in comparison with a licensed DTwP-Hib combination vaccine.

METHODS:

378 healthy infants were enrolled and randomly allocated to receive either three doses, at 6, 10 and 14 weeks of age, of Act-Hib in combination with BE DTwP (Group A, n = 160), TetrAct-Hib (Group B, n = 160), or BE DTwP and Act-Hib as separate injections (Group C, n = 58). Sera collected before the first dose and one month after the third dose were tested for antibodies to vaccine antigens. Safety was determined using parental diary cards.

RESULTS:

Anti-Hib antibody concentrations indicative of short-term protection (> 0.15 g/ml) were elicited in all but one subject in Group A (99.3%), and all subjects in Groups B and C. The concentration of 1 g/ml, considered to provide long-term protection, was achieved in 96.7%, 100% and 98.2% of the infants in Groups A, B and C, respectively. All children displayed satisfactory responses to the three DTwP component antigens, TetrAct-Hib eliciting higher titers against diphtheria and tetanus than BE DTwP. No vaccine-associated serious adverse events occurred. The BE DTwP vaccine was associated with more reports of fever than TetrAct-Hib, but most symptoms were regarded as mild and all resolved without sequelae.

CONCLUSIONS:

Combining Act-Hib and a local DTwP vaccine did not affect the anti-Hib response. In countries where DTwP vaccine available for use in the EPI program is manufactured by a local or other developing country manufacturer, mixing it with lyophilised Act-Hib is a reasonable option though the immunogenicity may have to be documented before routine use. However, use of TetrAct-Hib combination vaccine would be preferable in view of its lower reactogenicity and superior immunogenicity with respect to diphtheria and tetanus.

• Authors: Thomas Cherian, Niranjan Thomas, P Raghupathy, Isabelle Durot, Anil Dutta
• Journal: Indian pediatrics (Indian Pediatr) Vol. 39 Issue 5 Pg. 427-36 (May 2002) ISSN: 0019-6061 [Print] India
• PMID: 12037271 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria Toxoid
• Haemophilus Vaccines
• Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
• Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate
• Tetanus Toxoid
• Vaccines, Combined
• Vaccines, Conjugate

Topics

• Diphtheria Toxoid (adverse effects, immunology, therapeutic use)
• Female
• Haemophilus Infections (prevention & control)
• Haemophilus Vaccines (adverse effects, immunology, therapeutic use)
• Haemophilus influenzae type b (immunology)
• Humans
• Immunization Schedule
• India
• Infant
• Male
• Tetanus Toxoid (adverse effects, immunology, therapeutic use)
• Vaccines, Combined (adverse effects, immunology)
• Vaccines, Conjugate