NCT04270838

A Phase Ib/II Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG

A Phase Ib/II Age De-escalation, Dose Escalation, Partially Randomised, Open-label Head-to-head Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase Ib/II, open-label, head-to-head, age de-escalation dose-escalation, partially randomized trial to study the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in healthy adults (age 18-45 years) and young children (age 2-6 years). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given by intradermal injection.

Detailed description

A total of 120 participants will be recruited into 10 groups in Bagamoyo, Tanzania. The duration of the entire study will be up to 5.5 years per participant from the time of first vaccination. ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine (Verorab) will be given by intradermal injection at two to four anatomical sites (deltoids, thighs or suprascapular areas). All participants, regardless of which vaccine they receive at the start of the study, will receive a course of a licenced rabies vaccine (Verorab) during or at the end of the follow-up period.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx2 RabG	Single dose of ChAdOx2 RabG at different concentrations: 1x10\^10 and 5x10\^10
BIOLOGICAL	Inactivated Rabies Vaccine	A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units

Timeline

• Start date: 2022-02-17
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2020-02-17
• Last updated: 2025-11-18

Locations

1 site across 1 country: Tanzania