Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants

Summary

This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group. The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.

Timeline

Start

2016-02-15

Primary completion

2017-09-01

Completion

2017-12-22

Outcome

Met primary endpoint

paper were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). PMID 32251641 ↗

paper Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons. PMID 32251641 ↗

Publications

• Groome MJ, Fairlie L, Morrison J, Fix A, Koen A, Masenya M, Jose L, Madhi SA, Page N, McNeal M, Dally L, Cho I, Power M, Flores J, Cryz S. Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2020 Jul;20(7):851-863. doi: 10.1016/S1473-3099(20)30001-3. Epub 2020 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trivalent P2-VP8 Subunit Rotavirus Vaccine	Unknown	15 ug	Intramuscular
Subject	Trivalent P2-VP8 Subunit Rotavirus Vaccine	Unknown	30 ug	Intramuscular
Subject	Trivalent P2-VP8 Subunit Rotavirus Vaccine	Unknown	90 ug	Intramuscular

Indications

No indication recorded.