The quantity and quality of anti-PRP induced by the new Indonesian DTwP-HB-Hib vaccine compared to the Hib vaccine given with the DTwP-HB vaccine
Abstract: A phase II study of
DTwP-HB-Hib vaccine compared to Hib (monovalent) vaccine given simultaneously
with DTwP-HB vaccine has been done following the success of phase I study in
infants, where the new DTwP-HB-Hib has excellent safety profiles and antibody
responses in infants.
Objective To evaluate the titer (quantity), avidity, and bactericidal
capacity (quality of anti-polyribosylribitol phosphate/anti-PRP), of a new
combined Bio Farma DTwP-HB-Hib (pentavalent) vaccine, compared to the Hib
monovalent vaccine given simultaneously with the DTwP-HB vaccine (DTwP-HB+Hib).
Methods The study was a prospective, randomized, open label, phase II
trial. Subjects aged 6-11 weeks were allocated according to the randomization
list. The pentavalent group received the DTwP-HB-Hib vaccine, while the
monovalent group received the Hib monovalent and DTwP-HB vaccines separately.
Immunizations were given in three doses with 28-day intervals. Blood specimens
were taken before the first dose and 28 days after the last dose. We evaluated
anti-PRP titers quantity (geometric mean antibody concentration/GMC) and
seroprotection), followed by avidity and bactericidal (quality) testing. Titer
and avidity of anti-PRP were tested using a modified version of the improved
Phipps ELISA. Bactericidal capacity was evaluated using a Hib killing assay.
Immune responses against other antigens in the vaccine were reported
separately.
Results One hundred five subjects in the pentavalent group and 106
subjects in the Hib monovalent group were tested for anti-PRP titers. Only 102
specimens for each group were available for bactericidal testing, due to
insufficient volume for testing. Both vaccines induced similar anti-PRP titers,
for GMC and seroprotection. Avidity increases were 82.9% and 76.4% in the
pentavalent and Hib monovalent groups, respectively. Bactericidal activities
were 94.1% and 89.2%, respectively. Both avidity and bactericidal activity were
not significantly different between groups.
Conclusion DTwP-HB-Hib vaccine induced anti-PRP quantity and quality
comparable to those of the Hib monovalent vaccine given simultaneously with the
DTwP-HB vaccine.
Keywords: avidity; anti-PRP;
bactericidal; DTwP-HB-Hib; immunization; titer
Author: Novilia Sjafri
Bachtiar, Kusnandi Rusmil, Sunarjati Sudigdoadi, Hadyana Sukandar, Rini Mulia
Sari, Cissy B. Kartasasmita
Journal Code: jpkedokterangg170217
