Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG (NCT04162600) | Clinical Trial Compass
TerminatedPhase 1
Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG
Stopped: Since acceptable safety, tolerability, and immunogenicity was demonstrated at the highest dose tested (group 3, fully recruited), there was no scientific or ethical justification to recruit more participants into the mid-dose group (group 2).
United Kingdom18 participantsStarted 2020-01-02
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy adults aged 18 to 65 years.
✓. Able and willing (in the Investigator's opinion) to comply with all study requirements.
✓. Willing to allow the investigators to discuss the volunteer's medical history with their GP.
✓. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of screening and vaccination(s).
✓. Agreement to refrain from blood donation during the course of the study.
✓. Provide written informed consent.
Exclusion criteria
✕. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period. To be re- confirmed at the enrolment visit.
✕. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccine).
✕. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
✕. 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).
✕
What they're measuring
1
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Timeframe: Assessment of solicited AEs in the first 7 days post vaccination
2
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Timeframe: Unsolicited AEs to be assessed up to 28 days post vaccination.
3
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of serious adverse events.
Timeframe: SAEs will be collected from enrolment until the end of the follow-up period.(8 weeks)
4
Safety and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed by the occurrence of solicited adverse events.
Timeframe: At Day 0 (baseline), day 2, day 7, day 28 and day 56 post vaccination