Peer-reviewed article
Safety and immunogenicity of inactivated human Rotavirus vaccine in young children and infants: a randomized, placebo-controlled, double-blind, phase I clinical trial.
Zhou Y, Tan J, Liu Y, Pu J, Wu J et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested a new inactivated rotavirus vaccine in 288 healthy children aged 2 to 71 months using a randomized, placebo-controlled trial design. The vaccine was well tolerated with no serious adverse events, though some infants in the high-dose group experienced mild fever. The vaccine produced dose-dependent increases in antibody responses, with the highest dose and three-dose schedule showing the strongest immune response compared to placebo.
Key points
- No vaccine-related serious adverse events reported across any study cohort
- Clinically manageable mild-to-moderate transient fever observed only in the high-dose infant group
- Dose-dependent increases in neutralizing antibody and IgG responses across all age groups
- In 3-dose infant group receiving 320 EU dose: neutralizing antibody GMT of 551.98 versus 36.17 for placebo, with 83.33% seroconversion rate versus 10.00% for placebo
- Three-dose schedule showed better immunogenicity than two-dose regimen
Limitations
This is a phase I safety and immunogenicity trial; it does not measure effectiveness against actual rotavirus infection or disease prevention in the real world. The study cannot determine long-term protection duration or optimal dosing for different age groups beyond the tested cohorts.
Abstract
Inactivated rotavirus vaccines (IRV) are an effective approach for providing protection against the virus. This double-blind, randomised, placebo-controlled, dose-escalation phase I trial evaluated the safety and immunogenicity of IRV in 288 healthy children aged 2-71 months without prior rotavirus vaccination or HIV infection. We stratified participants by age (7-71 months and 2-6 months) and schedule (2 or 3 doses), before randomising them 3:1 to receive one of three antigen doses (80, 160, or 320 ELISA Unit [EU]), or aluminium adjuvanted placebo. The primary endpoints included adverse reactions/events within 30 min post-dose, adverse reactions/events during days 0-7 and 8-28/30 post-dose, and serious adverse events (SAEs) 6 months after the full course. The secondary endpoints were neutralizing antibody (NTA) geometric mean titres (GMT) and seroconversion rates (≥4-fold rise) at day 28 post-final dose. IRV was well tolerated, with no vaccine-related SAEs in any of the cohorts; we observed clinically manageable transient mild-to-moderate fever in the high dose infant group. Dose-dependent increases in NTA and IgG antibody responses were observed across all cohorts. In the 3-dose infant group, the 320 EU dose yielded a GMT of 551.98 (95% CI 338.39 ~ 900.40) compared to 36.17 for placebo, and a seroconversion rate of 83.33% (vs. 10.00% for placebo); the 3-dose schedule outperformed the 2-dose regimen. Our findings confirm that IRV has a favourable safety and immunogenicity profile. This trial is registered with ClinicalTrials.gov (NCT04626856).
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Inactivated rotavirus vaccine (IRV) at three different antigen doses (80, 160, or 320 ELISA Units) administered in either 2 or 3-dose schedules
- Population
- 288 healthy children aged 2-71 months without prior rotavirus vaccination or HIV infection, stratified by age (7-71 months and 2-6 months)
Key finding
No vaccine-related serious adverse events in any cohort
Y et al. · Europe PMC · 14 Aug 2026