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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).
A total of 40 participants will be recruited into 2 groups in Bagamoyo, Tanzania. The duration of the study will be up to 56 days per participant from the time of first vaccination. Participants in the intervention group will receive coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) at a single visit, while participants in the control group will receive only licenced rabies vaccine at 3 visits.
Participant groups who will receive coadministration of ChAdOx2 RabG and licensed rabies vaccine will also receive a 1-site IM vaccination with IRV on day 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 (Adults) | Experimental | Participants aged 18-45 years will receive coadministration of 5×10^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM) at a single visit. Rabies virus neutralisation antibody (VNA) titres will be determined at baseline and days 7, 14, 21, 28, and 56. Participants will receive a 1-site IM vaccination with IRV on day 56. |
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| Group A2 (Adults) | Active Comparator | Participants aged 18-45 years will receive a licensed IRV (2 site ID) at days 0, 3 and 7. Rabies virus neutralisation antibody (VNA) titres will be determined at baseline and days 7, 14, 21, 28, and 56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) | Biological | A single visit of coadministration of 5×10^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of solicited adverse events. | Occurrence of local and systemic solicited AEs | Assessment of solicited AEs in the first 7 days post vaccination |
| Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of unsolicited adverse events. | Occurrence of unsolicited local and systemic adverse events | Unsolicited AEs to be assessed up to 28 days post vaccination |
| Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of laboratory adverse events. | Occurrence of laboratory adverse events. | Clinical laboratory AEs to be assessed up to 28 days post vaccination. |
| Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of serious adverse events. | Occurrence of serious adverse events | SAEs will be collected from enrolment until the end of the follow-up period (Day 56). |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison of the immunogenicity of a singe-visit IM coadministration of ChAdOx2 RabG and licensed IRV versus three-visit ID administration of licensed IRV. | Rabies virus neutralising antibody (VNA) will be assessed by rapid fluorescent focus inhibition test (RFFIT). | Rabies virus neutralisation antibody titres will be determined at baseline and days 7, 14, 21, 28, and 56. |
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Inclusion Criteria:
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.
*Female volunteers are required to use an effective form of contraception during the course of the study. There is currently no information about the effect of this vaccine on a foetus. Acceptable forms of contraception for female volunteers include:
Established use of injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Total abdominal hysterectomy.
Planned long-term (at least 2 months from the date of the first vaccination) or permanent residence in Bagamoyo town.
Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2
Correctly answer all 10 questions on the protocol and study procedures understanding questionnaire within 2 attempts.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paschal Apanga | Contact | +441865 617624 | paschal.apanga@ndm.ox.ac.uk | |
| Adam Ritchie | Contact | +441865 617624 | adam.ritchie@ndm.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Alexander D Douglas | Jenner Institute, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifakara Health Institute | Bagamoyo | Tanzania |
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| Inactivated Rabies Vaccine (IRV) | Biological | A World Health Organization (WHO) prequalified IRV at two anatomical sites (2 site ID) on days 0, 3 and 7. |
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|
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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