Immunogenicity study of Haemophilus influenzae type B conjugate vaccine in Indian infants.
OBJECTIVE
To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC).


METHODS
Prospective multicenter study.


METHODS
Pediatric Out Patient Department of general hospitals in Pune and Mumbai.


METHODS
124 full term healthy infants brought for routine DPT/OPV immunization.


METHODS
Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections.


RESULTS
The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection.


CONCLUSIONS
HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.
Phadke
M A
MA
Department of Pediatrics, B.J. Medical College, Pune.
Kulkarni
M V
MV
Sovani
V B
VB
Lokeshwar
M R
MR
Venkataraman
R
R
D000907:Antibodies, Bacterial / Q000032:analysis*; D016667:Bacterial Capsules; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology* / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007109:Immunity; D007115:Immunization Schedule; D007194:India; D007223:Infant; D008297:Male; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage* / Q000276:immunology; D011446:Prospective Studies
D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D011135:Polysaccharides, Bacterial