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

doi:10.1016/j.vaccine.2021.06.056

Safety and immunogenicity of two formulations of rotavirus vaccine in Vietnamese infants

Vaccine. 2021 Jul 22;39(32):4463-4470. doi: 10.1016/j.vaccine.2021.06.056. Epub 2021 Jul 1.

Authors

V D Thiem¹, D D Anh¹, V H Ha¹, N D Hien², N T Huong², N T Nga³, T C Thang³, M M McNeal⁴, N Meyer⁴, H L Pham³, N M Huong³, G Gompana⁵, F Cassels⁶, Y Tang⁶, J Flores⁶, N Rathi⁷

Affiliations

¹ National Institute of Hygiene and Epidemiology, Viet Nam.
² Center for Research and Production of Vaccines and Biologicals (POLYVAC), Viet Nam.
³ PATH, Viet Nam.
⁴ Department of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
⁵ PATH, India.
⁶ PATH, USA.
⁷ PATH, India. Electronic address: nrathi@path.org.

PMID: 34218961
DOI: 10.1016/j.vaccine.2021.06.056

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.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral
Asian People
Humans
Immunogenicity, Vaccine
Infant
Rotavirus Infections* / prevention & control
Rotavirus Vaccines* / adverse effects
Rotavirus*
Vaccines, Attenuated / adverse effects
Vietnam

Substances

Antibodies, Viral
Rotavirus Vaccines
Vaccines, Attenuated

Associated data

ClinicalTrials.gov/NCT03703336