NCT07055880

Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)

Immunogenicity and Safety of Two Dosages of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Simulated Post-exposure Prophylaxis Regimen in Healthy Adults: A Randomized, Double-Blind, Active-controlled Phase Ⅱ Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.

Detailed description

This is a Phase Ⅱ, randomized, double-blind, active-controlled, dose-finding study. A total of 120 healthy participants aged 18\~59 years old will be enrolled. All participants will be randomized at a 1:1:1 ratio to three armes, which receive low-dosage Sinovac rabies vaccine, high-dosage Sinovac rabies vaccine or Sanofi Pasteur Verorab®, in an Essen schedule of 5 doses at D0, 3, 7, 14, 28 through intramuscular route (IM) as a simulated rabies PEP. Blood samples for immunogenicity assessment will be collected at D0, D14, D28, and D42. For safety assessment, the solicited local and systemic AEs within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. SAEs will also be collected during the whole study period.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Rabies Vaccine (Serum-free Vero Cell), Freeze-dried	Receiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
BIOLOGICAL	Verorab®	Receiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule

Timeline

• Start date: 2025-07-28
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Pakistan