The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

Main Article Content

Novilia Sjafri Bachtiar
Kusnandi Rusmil
Sunarjati Sudigdoadi
Cissy B Kartasasmita
Hadyana Hadyana

Abstract

Background 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.

Article Details

How to Cite
1.
Bachtiar N, Rusmil K, Sudigdoadi S, Kartasasmita C, Hadyana H. The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine. PI [Internet]. 22Jun.2017 [cited 21Sep.2019];57(3):129-7. Available from: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/1288
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Articles
Author Biographies

Novilia Sjafri Bachtiar, Bio Farma

Surveillance & Clinical Trial Division of Bio Farma. Was graduated from doctorel program in Padjadjaran University in 2016.

Kusnandi Rusmil, Child Health Department, Hasan Sadikin Hospital/Faculty of Medicine, Universitas Padjadjaran Bandung

Child Health Department, Hasan Sadikin Hospital/Faculty of Medicine, Universitas Padjadjaran Bandung

Sunarjati Sudigdoadi, Microbiology Department, Faculty of Medicine, Universitas Padjadjaran Bandung.

Microbiology Department, Faculty of Medicine, Universitas Padjadjaran Bandung.

Cissy B Kartasasmita, Child Health Department, Hasan Sadikin Hospital/Faculty of Medicine, Universitas Padjadjaran Bandung.

Child Health Department, Hasan Sadikin Hospital/Faculty of Medicine, Universitas Padjadjaran Bandung.

Hadyana Hadyana, Epidemiology and Biostatistics Department Faculty of Medicine, Universitas Padjadjaran Bandung

Epidemilogy and Biostatistics Department Faculty of Medicine, Universitas Padjadjaran Bandung
Received 2017-02-22
Accepted 2017-06-12
Published 2017-06-22

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