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

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Novilia Sjafri Bachtiar
Kusnandi Rusmil
Sunarjati Sudigdoadi
Hadyana Sukandar
Rini Mulia Sari
Cissy B. Kartasasmita

Abstract

Background 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.

Article Details

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1.
Bachtiar N, Rusmil K, Sudigdoadi S, Sukandar H, Sari R, Kartasasmita C. 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. PI [Internet]. 5Jan.2018 [cited 16Sep.2019];57(5):262-. Available from: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/1642
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Author Biographies

Novilia Sjafri Bachtiar, Bio Farma, Bandung, West Java

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

Kusnandi Rusmil, Universitas Padjadjaran Medical School, Bandung, West Java

Child Health Department, Universitas Padjadjaran Medical School/Dr. Hasan Sadikin Hospital, Bandung, West Java

Sunarjati Sudigdoadi, Universitas Padjadjaran Medical School, Bandung, West Java

Microbiology Department, Universitas Padjadjaran Medical School, Bandung, West Java

Hadyana Sukandar, Universitas Padjadjaran Medical School, Bandung, West Java

Epidemiology and Biostatistics Department, Universitas Padjadjaran Medical School, Bandung, West Java

Rini Mulia Sari, Universitas Padjadjaran Medical School, Bandung, West Java

Graduate School of Biomedical Sciences Master Program  Universitas Padjadjaran Medical School, Bandung, West Java

Cissy B. Kartasasmita, Department of Child Health, Universitas Padjadjaran Medical School/Dr. Hasan Sadikin Hospital, Bandung, West Java

Child Health Department, Hasan Sadikin Hospital/Faculty of Medicine, Universitas Padjadjaran Bandung
Received 2017-09-13
Accepted 2017-10-31
Published 2018-01-05

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