A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG in UK Healthy Adult Volunteer
Overview
- Phase
- Phase 1
- Intervention
- ChAdOx2 RabG
- Conditions
- Rabies
- Sponsor
- University of Oxford
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- •Any history of anaphylaxis in relation to vaccination.
- •Pregnancy, lactation or willingness/intention to become pregnant during the study.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition likely to affect participation in the study.
Arms & Interventions
5 x 10^9 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^9 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: ChAdOx2 RabG
5 x 10^9 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^9 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: Inactivated Rabies Vaccine
2.5 x 10^10 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 2.5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: ChAdOx2 RabG
2.5 x 10^10 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 2.5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: Inactivated Rabies Vaccine
5 x 10^10 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: ChAdOx2 RabG
5 x 10^10 vp of ChAdOx2 RabG
Volunteers will receive a standalone dose of ChAdOx2 RabG 5 x 10\^10 vp vaccination intramuscularly. Optional extended follow-up, volunteers will receive a complete pre-exposure prophylactic course of an existing rabies vaccine.
Intervention: Inactivated Rabies Vaccine
Outcomes
Primary Outcomes
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.
Time Frame: At Day 0 (baseline), day 2, day 7, day 28 and day 56 post vaccination
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
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.
Time Frame: SAEs will be collected from enrolment until the end of the follow-up period.(8 weeks)
Occurrence of serious adverse events
Secondary Outcomes
- Immunogenicity of the ChAdOx2 RabG vaccine(Day 365)