Rabies
Conditions
Keywords
Rabies, Rabies vaccine
Brief summary
A total of 3,000 participants will be enrolled, stratified by age into two groups: 600 participants aged 10-17 years and 2,400 participants aged 18-60 years. Within each age group, participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five vaccination schedule groups: Essen Control Group (Group A), Essen Experimental Group (Group B), Zagreb Experimental Group (Group C), Simplified Four-Dose Group 1 (Group D), and Simplified Four-Dose Group 2 (Group E). Among participants in the four experimental groups-Essen Experimental Group, Zagreb Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2-stratified block randomization will be applied. Within each age group and each vaccination schedule group, participants will be further randomized in a 1:1:1 ratio into three subgroups: those receiving a booster dose at Day 90 after completion of the primary immunization, those receiving a booster dose at Day 180, and those undergoing assessment of immune persistence at Day 360 after completion of the primary immunization.
Interventions
The vaccine will be administered via intramuscular injection into the deltoid muscle of the upper arm, with a human dose of 1.0 ml per injection. A total of 5 doses will be administered at Day 0, 3, 7, 14, and 28. Some participants will also undergo re-exposure immunization, receiving one additional dose of the vaccine on Days 0 and 3 of the re-exposure phase.
Sponsors
Ab&B Bio-tech Co., Ltd.JS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 10 and 60 years at the time of enrollment. * The participant and/or their legal guardian voluntarily agrees to participate in the trial and signs the informed consent form. * The participant and their family are able to comply with the trial follow-up schedule as required by the protocol (no plans for extended absence or relocation from the study site). * Female participants are neither pregnant nor lactating (negative urine pregnancy test prior to vaccination), and have no plans to become pregnant within 2 months after enrollment.
Exclusion criteria
a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the first dose. | Day 14 after the first dose. |
| Seroconversion rate of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose. | Day 14 after the last dose. |
| Incidence of adverse events within different timeframes (30 minutes, 0-7 days, 0-30 days) after each vaccine dose. | Within 30 minutes, 0-7 days, and 0-30 days after each dose |
| All serious adverse events (SAEs) occurring from the first dose of primary immunization to 6 months after completion of the primary immunization. | From the first dose of primary immunization to 6 months after completion |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentration (GMC) of rabies virus neutralizing antibodies in baseline seronegative participants 14 days after the last dose. | Day 14 after the last dose |
| Comparison of seroconversion rates and GMCs among baseline seronegative participants in the Essen Experimental Group, Simplified Four-Dose Group 1, and Simplified Four-Dose Group 2 at Days 28 and 42 after the first dose. | Days 28 and 42 after the first dose |
| Comparison of seroconversion rates and GMCs in baseline seronegative participants between the Essen Experimental Group and the Zagreb Experimental Group at Day 7 after the first dose. | Day 7 after the first dose |
Countries
China
Outcome results
None listed