Abstract
BACKGROUND: We performed a phase I experiment in a healthy teenage population in Sui County, Henan Province, China. The trial was randomized, double-blind, and placebo-controlled. METHODS: Ninety-six adolescents were randomly assigned in three groups (high-dose, medium-dose, and low-dose) to receive a dose of the vaccine or the placebo. The patients were monitored for adverse events (AEs) for up to 30 days after each dose of the vaccine and for up to 6 months after all doses of serious AEs (SAEs). All observed AEs and SAEs were reported. Microneutralization assays were used to measure geometric mean titers (GMTs) and seroconversion rates for neutralizing antibodies. IgA and IgG antibodies specific to the rotavirus were detected. RESULTS: The rates of total AEs in these groups were 8.33%, 37.50%, 12.50%, and 4.17%, respectively. The neutralizing antibody test revealed that the teenage groups with low, medium, and high doses of the vaccine had geometric mean titers of 424.32, 504.63, and 925.45, respectively, at 28 days following complete vaccination. The GMT of serum IgG at final immunization was 6501.86, 6501.82, and 10,173.3, in the low-dose, medium-dose, and high-dose groups, respectively. The GMT of serum IgA at final immunization was 2733.64, 2233.29, and 3596.66 in the low-dose, medium-dose group, and high-dose groups, respectively. CONCLUSIONS: The majority of adverse events (AEs) were deemed Grade 1 or 2, suggesting that the vaccine's safety profile is suitable for healthy adolescents. For the primary immunogenicity endpoints, a preliminary examination of the GMTs and the positive transfer rate of neutralizing antibodies in the different experimental groups revealed that, in adolescents aged 6-17, the high-dose group displayed significantly higher levels of neutralizing antibodies compared to the medium- and low-dose groups. Adolescents had few side effects from the new inactivated rotavirus vaccination, and it elicited an immune response.