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

• DOI: 10.1016/j.vaccine.2021.06.071
• Publication Date: 2021-07-06T11:56:41Z
• Authors: Jarir At Thobari; Wahyu Damayanti; Jonathan Hasian H...; Hera Nirwati; Kristy Iskandar; Samad; Julianita Fahmi; Rini Mulia Sari; Novilia Sjafri Ba...; Emma Watts; Julie E. Bines; Yati Soenarto
• Keywords: Rotavirus vaccine

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 disease in Indonesian infants is under further development PT Bio Farma, Indonesia. The aim develop a starting from that could improve implementation, safety, effectiveness vaccines. multi-site phase I study human neonatal RV3 (Bio Farma) adults, children, neonates Indonesia April 2018 March 2019. adult child cohorts were open-labeled single-dose, while cohort randomized, double-blind, placebo-controlled three-doses age 0–5 days, 8–10 weeks, 12–14 weeks. primary objective assess safety vaccines with immunogenicity virus fecal shedding as secondary endpoints neonates. Twenty-five 25 50 recruited, all but one completed procedures. Three serious adverse events (1 & 2 neonates), none assessed related investigational product (IP). group had significantly higher positive immune response (cumulative seroconverted SNA IgA) 28 days after three doses than those placebo (72% vs. 16.7%, respectively). GMT serum IgA post IP 1 (p < 0.05) 3 0.001) compared group. trial results show well tolerated participant (adults, neonates). this administered immunogenic. These promising support clinical Farma).