Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trial

• DOI: 10.1016/j.vaccine.2020.04.038
• Publication Date: 2020-05-23T05:25:45Z
• Authors: Shengli Xia; Jialiang Du; Jia Su; Yueyue Liu; Lili Huang; Qingchuan Yu; Zhiqiang Xie; Jiamei Gao; Bianli Xu; Xuejun Gao; Tai Guo; Yan Liu; Xu Zhou; Huan Yang
• Keywords: Rotavirus vaccine; Seroconversion

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy, immunogenicity and safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) against gastroenteritis (RVGE). Healthy children aged 6–13 weeks were enrolled randomized (1:1) either 3 oral doses LLR3 or placebo according 0, 1, 2 month schedule. The objectives evaluate efficacy (VE) RVGE any-severity, severe (sRVGE) inpatient caused by serotypes contained not after third dose. Immunogenicity also assayed subgroup. All adverse events (AEs) collected from 30 min each dose for immediate reaction, even entire study period, including serious AEs (SAEs) intussusception. VE sRVGE any serotype 56.6% (95% CI: 50.7, 61.8), 70.3% 60.6, 77.6) 74.0% 57.5, 84.1) respectively. 54.2% 47.5, 60.1) 70.4% 60.4, 77.9). rate seroconversion four-fold increase G2-, G3-, G4-specific IgA is 60.8%, 58.0%, 60.6% group, which higher than 21.35%, 22.7%, 23.1% group (p < 0.0001 G2, G3, G4), as well Geometric Mean Titer (GMT). Through trial, 65.91% 67.79% participants reported at least one AE, 0.02% SAEs groups, Two intussusception cases both group. In infants, provided substantial protection serotype, showed safety.