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Jul 20, 2016Article Details
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Main Article Content
A new combined DTP-HBV HiB vaccine- strategy for incorporation of HIB vaccination into childhood immunisation programmes
Abstract
Objectives. To evaluate the immunogenicity and reactogenicity of a pentavalent vaccine prepared by extemporaneously mixing diphtheria-tetanus pertussis-hepatitis B vaccine (DTPHBV) and lyophilised Haemophilus influenzae type B (Hib)tetanus conjugate vaccines in the same syringe, compared with the same vaccines given as separate, concomitant administrations.
Design. Open, randornised comparative study.
Setting. Durban, South Africa.
Subjects. A total of 120 healthy male and female infants were enrolled in the trial and randomised into two groups; group 1 received the combined administration (DTP-HBV-Hib), and group 2 received separate administrations of DTP-HBV and Hib vaccines. Vaccines were given as a three-dose primary vaccination course at 6,10 and 14 weeks of age.
Outcome measures. Antibody levels were measured using standard techniques and local and general solicited symptoms were recorded using diary cards.
Results. All subjects had seroprotective titres against diphtheria and tetanus; and antipolyribose-ribitol phosphate (PRP) titres ≥ 0.15 )μg/ ml 1 month after the final dose. A vaccine response (defined as post-vaccination titres ≥ 15 ELISA (EL).U/ ml in initially seronegative subjects; and as post- vaccination titres ≥ pre-vaccination titres in ini tially seropositive subjects) against the pertussis component was seen in 83% and 85% of subjects in the groups receiving combined and separate administration. No differences were seen in any of the geometric mean titres (GMTs) between the two administrations either 2 months after the second dose or 1 month after the final dose. There was no observed increase in reactogenicity in the group receiving the mixed administration.
Conclusions. The results demonstrate that combined DTPHBV- Hib vaccine is well tolerated and immunogenic
