Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants
V D Thiem, D D Anh, V H Ha, N D Hien, N T Huong, N T Nga, T C Thang, M M McNeal, N Meyer, H L Pham, N M Huong, G Gompana, F Cassels, Y Tang, J Flores, N Rathi, V D Thiem, D D Anh, V H Ha, N D Hien, N T Huong, N T Nga, T C Thang, M M McNeal, N Meyer, H L Pham, N M Huong, G Gompana, F Cassels, Y Tang, J Flores, N Rathi
Abstract
Background and aims: ROTAVIN-M1® (licensed, frozen vaccine) and ROTAVIN (second-generation, liquid candidate vaccine) are two rotavirus vaccine formulations developed from a live attenuated G1P8 (KH0118) strain by Center for Research and Production of Vaccines and Biologicals (POLYVAC), Vietnam. This study compared the safety and immunogenicity of these two formulations.
Methods: A Phase 3, randomized, partially double-blinded, active-controlled study was conducted in healthy infants aged 60-91 days in Vietnam. Infants received two doses of ROTAVIN or ROTAVIN-M1 in a ratio of 2:1 with an interval of 8 weeks. Solicited reactions were collected for 7 days after each vaccination. Blood samples were collected pre-vaccination and 4 weeks after the second vaccination in a subset of infants. Non-inferiority criteria required that the lower bound of 95% confidence intervals (CIs) of the post-vaccination anti-rotavirus IgA GMC (Geometric Mean Concentration) ratio of ROTAVIN/ROTAVIN-M1 should be >0.5. A co-primary objective was to compare the safety of the two vaccines in terms of solicited reactions.
Results: A total of 825 infants were enrolled. The post-vaccination GMC was 48.25 (95% CI: 40.59, 57.37) in the ROTAVIN group and 35.04 (95% CI: 27.34, 44.91) in the ROTAVIN-M1 group with an IgA GMC ratio of 1.38 (95% CI: 1.02, 1.86) thus meeting the pre-set criteria for non-inferiority. A total of 605 solicited reactions were reported in 297 (36.0%) participants with 35.4% in the ROTAVIN group and 37.2% in the ROTAVIN-M1 group. There were no cases of intussusception or death reported in the study.
Conclusions: Based on the data generated, it can be concluded that ROTAVIN is immunologically non-inferior and has similar safety profile to ROTAVIN-M1 when administered to infants in a two-dose schedule. Therefore, it can be considered as a more suitable option for programmatic use to prevent rotavirus diarrhoea in Vietnam and the Mekong region.
Trial registration number: ClinicalTrials.gov identifier: NCT03703336, October 11, 2018.
Keywords: Diarrhoea; Immunogenicity; Infants; Rotavirus; Safety; Vietnam.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr Nguyen Dang Hien and Dr Nguyen Thuy Huong are employed by Center for Research and Production of Vaccines and Biologicals (POLYVAC), Vietnam, which manufactures the study vaccines Rotavin and Rotavin-M1.
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed