NCT05937113

Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally

A Cross-over, Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S on Healthy Vietnamese Volunteers With 3 Doses of Pre-exposure Prophylaxis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Vietnam Military Medical University · Academic / Other
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Randomized, open-label, prospective, before-and-after comparison study in the same group. Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers.

Detailed description

1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone). Pre-exposure prophylaxis regimens for two groups * Intramuscular 1ml on days D0, D7 and D21-28 * Intradermal injection 0.1 ml on days D0, D7 and D21-28 Randomization was performed according to two age stratifications: * Stratification of research subjects from 5-15 years old * Stratification of research subjects from 16-60 years old Population selected research subjects in the community in Dong Hung district, Thai Binh province

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	RABIVAX-S	1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone). Pre-exposure prophylaxis regimens for two groups * Intramuscular 1ml on days D0, D7 and D21+7 * Intradermal injection 0.1 ml on days D0, D7 and D21+7 Blood samples were collected on days D0, D7 and D21 - 28

Timeline

• Start date: 2020-06-13
• Primary completion: 2020-07-02
• Completion: 2020-10-30
• First posted: 2023-07-10
• Last updated: 2023-07-20

Locations

1 site across 1 country: Vietnam