About this trial
This is a phase II randomised, open-label study to assess the safety and immunogenicity of coadministration of the candidate rabies vaccine ChAdOx2 RabG and licensed vaccine in healthy adults (18-45 years old). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given either intramuscularly (i.e., for the intervention group) or by intradermal injection (i.e., for the control group).
Eligibility criteria
Qualifiers
Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
(Female only participants): Must be non-pregnant (as demonstrated by a negative serum pregnancy test) and willing to use an effective form of contraception.
Established use of injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Disqualifiers
Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
Clinically significant history of skin disorder, allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data as judged by the PI or other delegated individual.
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
Trial design
Treatments tested in this trial
- Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV)
- Inactivated Rabies Vaccine (IRV)