NCT04162600

Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG

A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG in UK Healthy Adult Volunteer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx2 RabG vaccine in healthy UK volunteers aged 18-65. The vaccine will be administered intramuscularly (IM).

Detailed description

Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a total of 12 volunteers will be enrolled. Staggered enrolment will apply between study groups and for the first three volunteers within each group. The study includes an optional extended follow-up period, lasting one month and starting one year after vaccination. Volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine, allowing study of the immunological memory (recall response) induced by ChAdOx2 RabG. A second optional element of the study is the collection of saliva samples at each visit for the study of shedding of EBV and CMV.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx2 RabG	Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
BIOLOGICAL	Inactivated Rabies Vaccine	A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
BIOLOGICAL	ChAdOx2 RabG	Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp
BIOLOGICAL	ChAdOx2 RabG	Single dose of ChAdOx2 RabG at different concentrations: 5 x 10\^9 vp, 2.5 x 10\^10 vp, 5 x 10\^10 vp.
BIOLOGICAL	Inactivated Rabies Vaccine	A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
BIOLOGICAL	Inactivated Rabies Vaccine	A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.

Timeline

• Start date: 2020-01-02
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2019-11-14
• Last updated: 2024-11-08

Locations

1 site across 1 country: United Kingdom