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

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,...

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Bibliographic Details
Published in:Vaccine 2021-07, Vol.39 (33), p.4651-4658
Main Authors: At Thobari, Jarir, Damayanti, Wahyu, Haposan, Jonathan Hasian, Nirwati, Hera, Iskandar, Kristy, Samad, Fahmi, Julianita, Sari, Rini Mulia, Bachtiar, Novilia Sjafri, Watts, Emma, Bines, Julie E., Soenarto, Yati
Format: Article
Language:English
Subjects:
Acids
Adults
Adverse events
Age
Antacids
Birth
Breastfeeding & lactation
Children
Children & youth
Clinical trials
Consent
Diarrhea
Drug stores
Gastroenteritis
Good Manufacturing Practice
Health care
Immune response
Immune system
Immunization
Immunogenicity
Immunoglobulin A
Intestinal obstruction
Licensed products
Manufacturing
Neonates
Newborn babies
Placebos
Rotavirus
Rotavirus vaccine
RV3
Safety
Schedules
Vaccines
Viruses
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Summary: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. 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 placebo-controlled 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. 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 
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2021.06.071