SAFETY AND IMMUNOGENICITY OF DIFFERENT DOSES OF
DTP-Hib and DTP-Hib-HEPATITIS B VACCINES, IN INDONESIAN INFANTS
Punjabi NH1, Richie EL2,
Simanjuntak CH1, HarjantoSJ1, WangsasaputraF1,
Arjoso S1, Rofiq A1, Prijanto M1,
Yulitasari1, Cryz SJ3
1 Ministry of Health,
Republic of Indonesia, Jakarta, Indonesia, 2Yorkwood Medical
Center, Baltimore, Maryland, 3 SSVI, Bern, Switzerland
Objective: To overcome Hib vaccine's cost problem that has prevented its inclusion in basic
immunization programs in developing countries by evaluating the
immunogenicity and adverse reactions from lower doses of Hib-PRP and
combination of DTP-Hib-Hepatitis B.
Methods: to utilize a
reduced dose of Hib vaccine and or combination with other vaccine(s): DTP
and with or without Hepatitis B.
Results: double-blind studies were
conducted in Jakarta and its suburbs. Total of 1,048 infants received three
doses of DTP vaccine combined with the usual 10 mg dose or with a reduced dose of 5, 2.5 or
1.25 mg of Hib-PRP and in
the second study 619 infants received three doses of DTP and Hepatitis B
vaccines combined with the usual or a reduced dose of 2.5mg of Hib-PRP. Adverse reactions were almost
similar among all groups.
Immune response data before and after primary immunization showed
that all vaccinees tested had a fourfold increases in antibodies against
all DTP antigens. In addition, for all four doses of Hib, 99.6% of infants
produced > 0.15 mg
/ml of antibody to Hib-PRP, and 96.4% showed levels >1.0 mg/ml after primary immunization, levels that
correlate with short and long-term immunity.
Conclusion: This study
demonstrates that primary vaccination with half, one-fourth, or one eighth
of the usual dose of Hib-PRP, combined with cellular DTP alone or with
Hepatitis B, produces protective immune responses, and side effects that
are comparable to DTP vaccination alone.