NCT07326878

Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine

A Single-center, Randomized, Double-blind, and Placebo Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine in People Aged 6 Months to 59 Years

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Months – 59 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).

Detailed description

This is a single-center, randomized, double-blinded, placebo-controlled phase I clinical trial in which three dose levels of the Enterovirus Type71 -Coxsackievirus Type A16 bivalent vaccine will be evaluated the safety and preliminary immunogenicity in subjects aged 6 months to 59 years. A total of 144 participants will be enrolled, including 48 adults (aged 18-59 years), 48 adolescents (aged 6-17 years), and 48 children (aged 6 months-5 years). Participants will be randomized into vaccine group and placebo group in a 3:1 ratio, and receive two doses of vaccine or placebo according to the 0- and 28-day immunization schedule.The dose escalation principle within each age group is from low to high doses, and the sequential enrollment principle between different age groups is from adults to children. Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events within 30 minutes/7 days/28 days after each dose, as well as the incidence of serious adverse events within 12 months after the final dose which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-EV71 neutralizing antibodies and anti-CA16 neutralizing antibodies 28 days after the final dose.

Conditions

• Hand, Foot and Mouth Disease (HFMD)
• HFMD
• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	Low Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)	Low-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
BIOLOGICAL	Medium Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)	Medium-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
BIOLOGICAL	High Dose Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine, inactivated (human diploid cell)	High-dose vaccine，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval
BIOLOGICAL	Placebo	Placebo，dosage and immunization procedure: 0.1 ml/dose, 2 doses, 28-day interval

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-08-15
• Completion: 2027-08-15
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: China