A new combined DTP-HBV-Hib vaccine--strategy for incorporation of Hib vaccination into childhood immunisation programmes.
OBJECTIVE
To evaluate the immunogenicity and reactogenicity of a pentavalent vaccine prepared by extemporaneously mixing diphtheria-tetanus pertussis-hepatitis B vaccine (DTP-HBV) and lyophilised Haemophilus influenzae type B (Hib)-tetanus conjugate vaccines in the same syringe, compared with the same vaccines given as separate, concomitant administrations.


METHODS
Open, randomised comparative study.


METHODS
Durban, South Africa.


METHODS
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 2, 4 and 6 months [corrected] of age.


METHODS
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 > or = 0.15 microgram/ml 1 month after the final dose. A vaccine response (defined as post-vaccination titres > or = 15 ELISA (EL).U/ml in initially seronegative subjects; and as post-vaccination titres > or = pre-vaccination titres in initially 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 DTP-HBV-Hib vaccine is well tolerated and immunogenic.
Ramkissoon
A
A
Medical Research Council, 296 Umbilo Rd, Durban.
Coovadia
H M
HM
Jugnundan
P
P
Willems
P
P
Clemens
B R
BR
D000907:Antibodies, Bacterial / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male
D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines