Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study

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Kusnandi Rusmil
Eddy Fadlyana
Novilia Sjafri Bachtiar
Hadyana Hadyana


Background The World Health Organization (WHO) has
recommended the introduction ofhepatitis B (HB) and Haemophilus
influenza type b (Hib) vaccines into routine childhood vaccination
programs. A new diptheria/tetanus/pertussis (DTP) /hepatitis B/Hib
pentavalent combination vaccine has been developed.
Objective To evaluate the safety and immunogenicity of a new
combination DTP/HB/Hib liquid vaccin e in infants.
Met hods An open-label, uncontrolled, prospective intervention
phase I study was con ducted on 30 healthy infants aged 6- 11
weeks. Each subject received 3 doses of DTP/HB/Hib vaccine,
formulated by Bio Fanna, 0.5 mL intramuscularly at the left
anterolateral thigh region using a 25-gauge n eedle of 25 mm
length . Subjects were followed for 1 month after administration of
each vaccine dose to evaluate its safety, while serum anti-diphteria,
tetanus, HB, Hib, and per tussis antibodies were measured prior
to the l '' dose and 1 month after the Jtd dose.
Results Among 30 vaccinated subjects, 18 infants had fever within
24 hours after the first vaccination. Most cases of fever were mild
in intensity and resolved within 24 hours. No other systemic or
local reactions, or serious adverse events were observed in our
subjects during the study. The immunogenicity results after Jtd
vaccine dose showed that the geometric mean titer of the antipolyribosylribitol
phosphate (PRP) antibody levels increased
significantly from 0.0041μ,g/mL to 4.3 7 μ,g/mL after vaccination,
and most infants h ad a fourfo ld or greater rise in antibody levels
over their pre-injection levels . All subjects who received DTP/
HB/Hib liquid vaccine had seropro tective antibodies against
tetanus, diphtheria,a and hepatitis B, while 29/30 infants had
seroprotective antibodies against pertussis.
Conclusion This new diphtheria/tetanus/pertusis/hepatitis B/Hib
combination vaccine has excellent safety profile and antibody
responses in infants. These results encourage further clinical
evaluation in phase II.

Article Details

How to Cite
Rusmil K, Fadlyana E, Bachtiar N, Hadyana H. Safety and immunogenicity of the DTP/HB /Hib combination vaccine: phase I study. PI [Internet]. 30Dec.2013 [cited 23Sep.2020];53(6):309-4. Available from:
Received 2016-08-29
Accepted 2016-08-29
Published 2013-12-30


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