NCT07028801

Clinical Trial of Freeze-dried Human Rabies Vaccine (Human Diploid Cells)

A Randomized, Blinded, Parallel Controlled, Non-inferiority Design Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Human Diploid Cells) Administered to Participants Aged 10 to 60 Years With Different Immunization Schedules

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Ningbo Rongan Biological Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The Phase 3 clinical trial of freeze-dried human rabies vaccine (human diploid cells) adopted a randomized, blinded, parallel control,non-inferiority design,and administered vaccines to participants aged 10 to 60 years with different immunization schedules (5-dose schedule group, two simple 4-dose schedule groups, and 2-1-1 schedule group) to evaluate the immunogenicity and safety of the vaccine.

Detailed description

The trial will use a randomized, blinded, parallel-group, non-inferiority design. A total of 3000 participants will be planned to be randomly assigned in a 1:1:1:1:1 ratio to the 5-dose control vaccine schedule, the 5-dose experimental vaccine schedule, the simple 4-dose experimental vaccine schedule 1, the simple 4-dose experimental vaccine schedule 2, and the 2-1-1 trial vaccine schedule, with 600 participants in each group, including 100 participants aged 10 to 17 years and 500 participants who will be 18-60 years old. Immunogenicity visits will be scheduled for all participants: (1) 5-dose schedule group: before dose 1, day 7 (before dose 3), day 14 (7 after dose 3, before dose 4), day 28 (14 after dose 4, before dose 5), day 42 (14 days after the full schedule); (2) Simple four-dose schedule group 1: before dose 1, day 14 (7 days after dose 3 and before dose 4), day 28 (14 days after the full dose), and day 42 (28 days after the full schedule); (3) Simple four-dose schedule group 2: before dose 1, day 14 (7 days after the third dose), day 28 (before the fourth dose), and day 42 (14 days after the full schedule); (4) 2-1-1 schedule group: before dose 1, day 7 (before the third dose), day 14 (7 days after the third dose) and day 35 (14 days after the full schedule). If the vaccination is delayed, the blood collection time will be postponed according to the vaccination time of the corresponding dose. A total of 1200 participants in the immune persistence subgroup (including 200 participants aged 10-17 years and 1000 participants aged 18-60 years) will be selected. Blood samples will be collected at 3 months and 6 months after the full schedule of vaccination to evaluate the immune persistence. The first 40% of participants in the 10 to 17 years of age group and the 18 to 60 years of age group enrolled at each site will be selected as participants in the immune persistence subgroup. All participants will be observed for safety events that will occur from the first dose through 30 days after the full schedule and for SAEs and pregnancy events that will be reported from the first dose through 6 months after the full schedule.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Freeze-dried human rabies vaccine (human diploid cells)	This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7, 14 and 28, total 5 doses
BIOLOGICAL	Freeze-dried human rabies vaccine (human diploid cells)	This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 14, total 4 doses
BIOLOGICAL	Freeze-dried human rabies vaccine (human diploid cells)	This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 1 dose on day 0, 3, 7 and 28, total 4 doses
BIOLOGICAL	Freeze-dried human rabies vaccine (human diploid cells)	This vaccine is produced by Ningbo Rongyu Biopharmaceutical Co., LTD. Participants will be administered 4 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection. Receive 2 dose on day 0, 1 dose on day 7 and 21, total 4 doses
BIOLOGICAL	Freeze-dried human rabies vaccine (human diploid cells)	This vaccine is produced by Chengdu Kanghua Biological Products Co., LTD Participants will be administered 5 doses of freeze-dried human rabies vaccine (human diploid cells) by intramuscular injection Receive 1 dose on day 0, 3, 7, 14and 28, total 5 doses

Timeline

• Start date: 2025-07-31
• Primary completion: 2025-09-30
• Completion: 2026-03-31
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: China