The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine
Abstract: Haemophilus
influenzae type b (Hib) causes infection with predominant manifestations of
pneumonia, meningitis, and other invasive diseases, occurring primarily in
children aged under 2 years, particularly in infants. The World Health Organization (WHO) and
Indonesian Technical Advisory Group for Immunization recommend to include the
Hib vaccine into the national immunization program. The newly developed
DTwP-HB-Hib combination vaccine is anticipated to be the preferred choice for
Hib vaccine introduction; it is efficient, simple, and has higher coverage.
Objective To evaluate the immunogenicity and safety of a new, combined
Bio Farma DTwP-HB-Hib vaccine, compared to the registered Hib monovalent
vaccine given simultaneously with the local DTwP-HB vaccine, when used as the
primary vaccination of Indonesian infants.
Methods A prospective, randomized, open-label, phase II study was
conducted on the DTwP-HB-Hib vaccine compared to the Hib (registered) vaccine
given simultaneously with the DTwP-HB vaccine, in Bandung from July 2011 to
January 2012. Infants were serially vaccinated at 6-11, 10-15, and 14-19 weeks.
Serological assessments were done prior to the first vaccine dose and 28 days
after the third dose. Safety was assessed from the time of first injection
until 1 month after the last injection.
Results Of 220 healthy infants enrolled, 211 completed the study, with
105 receiving the combined vaccine and 106 the two separate vaccines. All
vaccines were well tolerated. No differences in rates of local and systemic
reactions were seen between the two methods of administration. No serious
adverse events were considered to be related to the vaccines. In the
DTwP-HB-Hib primary-vaccination group, at least 98% of the infants reached
protective levels of antibodies (seropositivity) against the antigens employed
in the vaccines while 96% in the control group.
Conclusion The DTwP-HB-Hib combined vaccine is immunogenic and safe, as
well as comparable to the Hib vaccine given simultaneously with to the DTwP-HB
vaccine.
Keywords: DTwP-HB-Hib; Hib;
immunogenicity; infants; safety; vaccine
Author: Novilia Sjafri
Bachtiar, Kusnandi Rusmil, Sunarjati Sudigdoadi, Cissy B Kartasasmita, Hadyana
Hadyana
Journal Code: jpkedokterangg170171
