Safety and immunogenicity of human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, and neonates in Indonesia: Phase I Trial

Thobari, Jarir At and Damayanti, Wahyu and Haposan, Jonathan Hasian and Nirwati, Hera and Iskandar, Kristy and Samad, Samad and Fahmi, Julianita and Sari, Rini Mulia and Bachtiar, Novilia Sjafri and Watts, Emma and Bines, Julie E. and Soenarto, Yati (2021) Safety and immunogenicity of human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, and neonates in Indonesia: Phase I Trial. Vaccine, 39 (33). pp. 4651-4658. ISSN 0264410X

[thumbnail of Safety and immunogenicity of human neonatal RV3 rotavirus vaccine.pdf] Text
Safety and immunogenicity of human neonatal RV3 rotavirus vaccine.pdf - Published Version
Restricted to Registered users only

Download (787kB) | Request a copy

Abstract

Background:Despite safe and effective WHO prequalified rotavirus vaccines, at least 84 million children
remain unvaccinated. A birth dose schedule of the RV3-BB vaccine was reported to be highly efficacious against severe rotavirus disease in Indonesian infants and is under further development at PT Bio Farma, Indonesia. The aim is to develop a rotavirus vaccine starting from birth that could improve the implementation, safety, and effectiveness of vaccines.

Methods:A multi-site phase I study of a human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, neonates in Indonesia from April 2018 to March 2019. The adult and child cohorts were open-labeled single-dose, while the neonatal cohort was randomized, double-blind, and placebocontrolled three-doses at the age of 0–5 days, 8–10 weeks, and 12–14 weeks. The primary objective was to assess the safety of vaccines with the immunogenicity and vaccine virus fecal shedding as the secondary endpoints in neonates.

Results:Twenty-five adults, 25 children, and 50 neonates were recruited, and all but one in the neonatal
cohort completed all study procedures. Three serious adverse events were reported (1 adult & 2 neonates), but none were assessed related to investigational product (IP). The neonatal vaccine group had a significantly higher positive immune response (cumulative seroconverted SNA and IgA) 28 days after three doses than those in the placebo group (72% vs. 16.7%, respectively). The GMT of serum IgA in the
vaccine group was significantly higher at post IP dose 1 (p < 0.05) and post IP dose 3 (p < 0.001) compared
to the placebo group.

Conclusion:The trial results show that the RV3 rotavirus vaccine (Bio Farma) is well tolerated in all participant cohorts (adults, children, and neonates). Three doses of this vaccine administered in a neonatal schedule were immunogenic. These promising results support further clinical development of the RV3 rotavirus vaccine (Bio Farma)

Item Type: Article
Subjects: R Medicine > RB Biomedical Sciences
Divisions: Faculty of Medicine, Public Health and Nursing > Public Health and Nutrition
Depositing User: Erlita Cahyaningtyas Cahyaningtyas
Date Deposited: 21 Oct 2024 03:18
Last Modified: 21 Oct 2024 03:18
URI: https://ir.lib.ugm.ac.id/id/eprint/9744

Actions (login required)

View Item
View Item