RabiesPhase 1/2NCT04270838
A Phase Ib/II Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG
A Phase 1/2 study testing ChAdOx2 RabG and Inactivated Rabies Vaccine in people with Rabies, run by University of Oxford at 1 site in Tanzania.
Trial summary
This is a Phase Ib/II, open-label, head-to-head, age de-escalation dose-escalation, partially randomized trial to study the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in healthy adults (age 18-45 years) and young children (age 2-6 years). Read more about this study
- Who is it for?
- Ages 2 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- ChAdOx2 RabG and Inactivated Rabies Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteTanzania
- Study dates
- 17 Feb 2022to Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult groups: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
- Adult groups (Female only participants): Must be non-pregnant (as demonstrated by a negative urine pregnancy test) and willing to use an effective form of contraception. Or if they agree to an extended period of follow-up of up to 5.5 years, use an effective form of contraception during the first year of enrolment in the study).
- Paediatric groups: Healthy male or female young children aged 2-6 years at the time of enrolment with signed consent obtained from parents or guardians.
- Paediatric groups: completion of the Expanded Programme on Immunisation (EPI) at least 6 months prior to study enrolment.
- Planned long-term (at least 61 months from the date of the first vaccination) or permanent residence in Bagamoyo town.
- Adults with a Body Mass Index (BMI) 18 to 35 Kg/m2; or young children with Z-score of weight-for-age within ±2SD.
- Correctly answer all 10 questions on the protocol and study procedures understanding questionnaire within 2 attempts.
Who cannot join
- 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).
- Any condition which would place the individual at elevated risk of serious COVID-19 infection, or any other factor which may make the individual eligible for priority COVID-19 vaccination (i.e. ahead of others in their age group).
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including IRVs e.g. amphotericin B, chlortetracycline, neomycin, polymyxin, streptomycin
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- Any history of anaphylaxis in relation to vaccination.
- Clinically significant laboratory abnormality as judged by the PI or other delegated individual.
- Receipt of any previous rabies vaccinations, including an incomplete course.
- History of vaccination with previous adenoviral vectored vaccines in the 6 months prior to enrolment in the study, or of vaccination with any other vaccine (including non-adenovirus-vectored COVID-19 vaccines) in the 28 days prior to enrolment.
- Planned / likely receipt of any other vaccine within 28 days after enrolment.
- History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, or continuous anticoagulation e.g., with warfarin
- History of confirmed major thrombotic event, (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism) or,
- History of antiphospholipid syndrome.
- History of prior receipt of unfractionated heparin
- History of heparin induced thrombocytopenia
- Receipt of any blood products/ immunoglobulins within the three months preceding the planned administration of the vaccine candidate.
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).
- Likelihood of travel away from the study area.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Contraindication to use of paracetamol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/II Age De-escalation, Dose Escalation, Partially Randomised, Open-label Head-to-head Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG
This is a Phase Ib/II, open-label, head-to-head, age de-escalation dose-escalation, partially randomized trial to study the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in healthy adults (age 18-45 years) and young children (age 2-6 years). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given by intradermal injection.
Read the detailed description
A total of 120 participants will be recruited into 10 groups in Bagamoyo, Tanzania. The duration of the entire study will be up to 5.5 years per participant from the time of first vaccination. ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine (Verorab) will be given by intradermal injection at two to four anatomical sites (deltoids, thighs or suprascapular areas).
All participants, regardless of which vaccine they receive at the start of the study, will receive a course of a licenced rabies vaccine (Verorab) during or at the end of the follow-up period.
- Conditions
- Rabies
- Being tested
- ChAdOx2 RabG, Inactivated Rabies Vaccine
- Keywords
- Vaccine
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx2 RabGBiological
Single dose of ChAdOx2 RabG at different concentrations: 1x10^10 and 5x10^10
Inactivated Rabies VaccineBiological
Also called Verorab
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units
| Study group | Role | What they receive |
|---|---|---|
| Group AC1 (Adult low dose) | Experimental | Volunteers aged 18-45 years. Volunteers will receive a standalone dose of 2.5×10^10 vp ChAdOx2 RabG on D0. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| Group AC2 (Adult high dose) | Experimental | Volunteers aged 18-45 years. Volunteers will receive a standalone dose of 5×10^10 vp ChAdOx2 RabG. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| Group AC3 (Adult preferred dose) | Experimental | Volunteers aged 18-45 years. Volunteers will receive a preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| Group AV1 (Adult single-visit Verobab) | Experimental | Volunteers aged 18-45 years. Volunteers will receive Rabies IRV on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: Inactivated Rabies Vaccine |
| PC1a (Paediatric low dose) | Experimental | Volunteers aged 2-6 years. Volunteers will receive a standalone dose of 1×10^10 vp ChAdOx2 RabG on D0. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| PC1b (Paediatric low dose) | Experimental | Volunteers aged 2-6 years. Volunteers will receive a half adult preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| PC2 (Paediatric high dose) | Experimental | Volunteers aged 2-6 years. Volunteers will receive a full adult preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| PC3 (Paediatric preferred dose) | Experimental | Volunteers aged 2-6 years. Volunteers will receive a paediatric preferred dose of ChAdOx2 RabG on D0. The paediatric preferred dose will be 50-100% of the adult preferred dose. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| PV1 (Paediatric single-visit Verobab) | Experimental | Volunteers aged 2-6 years. Volunteers will receive Rabies IRV (Verorab) as a 2 site ID on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: Inactivated Rabies Vaccine |
| PV2 (Paediatric two-visit Verobab) | Experimental | Volunteers aged 2-6 years. Volunteers will receive Rabies IRV (Verorab) as a 2 site ID on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. Receives: Biological: Inactivated Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache, fatigue and nausea).
Measured: Assessment of solicited AEs in the first 7 days post vaccination
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Occurrence of unsolicited local and systemic adverse events
Measured: Unsolicited AEs to be assessed up to 28 days post vaccination
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Occurrence of serious adverse events
Measured: SAEs will be collected from enrolment until the end of the follow-up period (Day 1839)
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
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.
Measured: Clinical Laboratory AEs to be assessed up to 28 days post vaccination
Secondary outcomes (2)
Immunogenicity of ChAdOx2 RabG administered to adults and young children residing in a rabies endemic country following primary vaccination, including the length of response maintenance, and secondary (recall) response.
Rapid fluorescent focus inhibition test (RFFIT) of rabies virus neutralising antibody
Measured: At Days 0, 28, 56, 186, 365, 730, 1095, 1460, 1825
Comparison of immunogenicity of ChAdOx2 RabG with a single visit two site intradermal IRV PrEP regimen
Anamnestic rabies virus neutralising antibody response as assessed by rapid fluorescent focus inhibition test (RFFIT), at 7 days following simulated rabies virus exposure through IRV administration
Measured: At days SPEP+0 and SPEP+7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start17 Feb 2022
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Alexander D Douglas, Principal investigator, Jenner Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270838
- Sponsor's protocol ID
- RAB002
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be made available on direct request to the Principal Investigator. Proposals will be reviewed by the sponsor, Principal Investigator, and collaborators on the basis of scientific merit. Data will be shared following approval of the proposal and signed data-access agreements.
Publications
Ritchie AJ, Hassan O, Urasa N, Apanga PA, Kimathi R, Kalinga WF, Mtaka IM, Lyimo RG, Shabani MM, Orliacq F, Berg A, Xiang Z, Ahmed S, Athuman T, Ertl HCJ, Olotu A, Douglas AD; RAB002 study team. Safety and immunogenicity of a single-dose adenovirus-vectored rabies vaccine over 1 year in adults and children in Tanzania: interim data from an ongoing, partly randomised, controlled, phase 1b/2 trial. Lancet Infect Dis. 2026 Aug;26(8):843-857. doi: 10.1016/S1473-3099(26)00071-X. Epub 2026 Apr 28.
PubMed 42066780
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Age De-escalation, Dose Escalation, Partially Randomised, Open-label Head-to-head Study of the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG
- ClinicalTrials.gov ID
- NCT04270838
- Acronym / sponsor ID
- RAB002
- Conditions
- Rabies
- Keywords
- Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib/II, open-label, head-to-head, age de-escalation dose-escalation, partially randomized trial to study the safety and immunogenicity of the candidate rabies vaccine ChAdOx2 RabG in healthy adults (age 18-45 years) and young children (age 2-6 years). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given by intradermal injection.
Detailed description
A total of 120 participants will be recruited into 10 groups in Bagamoyo, Tanzania. The duration of the entire study will be up to 5.5 years per participant from the time of first vaccination. ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine (Verorab) will be given by intradermal injection at two to four anatomical sites (deltoids, thighs or suprascapular areas).
All participants, regardless of which vaccine they receive at the start of the study, will receive a course of a licenced rabies vaccine (Verorab) during or at the end of the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group AC1 (Adult low dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 18-45 years. Volunteers will receive a standalone dose of 2.5×10^10 vp ChAdOx2 RabG on D0. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| Group AC2 (Adult high dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 18-45 years. Volunteers will receive a standalone dose of 5×10^10 vp ChAdOx2 RabG. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| Group AC3 (Adult preferred dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 18-45 years. Volunteers will receive a preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| Group AV1 (Adult single-visit Verobab) | Experimental | Biological: Inactivated Rabies VaccineVolunteers aged 18-45 years. Volunteers will receive Rabies IRV on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PC1a (Paediatric low dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive a standalone dose of 1×10^10 vp ChAdOx2 RabG on D0. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PC1b (Paediatric low dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive a half adult preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PC2 (Paediatric high dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive a full adult preferred dose of ChAdOx2 RabG on D0. The adult preferred dose will be 2.5×10^10 vp OR 5×10^10 vp. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PC3 (Paediatric preferred dose) | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive a paediatric preferred dose of ChAdOx2 RabG on D0. The paediatric preferred dose will be 50-100% of the adult preferred dose. Volunteers will receive two doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PV1 (Paediatric single-visit Verobab) | Experimental | Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive Rabies IRV (Verorab) as a 2 site ID on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
| PV2 (Paediatric two-visit Verobab) | Experimental | Biological: Inactivated Rabies VaccineVolunteers aged 2-6 years. Volunteers will receive Rabies IRV (Verorab) as a 2 site ID on D0. Volunteers will receive two further doses of Rabies IRV as simulated post-exposure prophylaxis (SPEP), 14 days apart during the follow-up period. All participants will receive Verorab as a 4 site ID on SPEP+0, and Verorab as a 2 site ID on SPEP+14. Participants who return a virus neutralising antibody (VNA) result below 0.5IU/mL will be randomised (1:1 ratio) for the SPEP+0 visit to happen at the next available visit or at the final annual visit. Any participants who do not return a VNA result below 0.5IU/mL will have their SPEP+0 visit take place at the final annual visit. |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adult groups: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent.
- Adult groups (Female only participants): Must be non-pregnant (as demonstrated by a negative urine pregnancy test) and willing to use an effective form of contraception. Or if they agree to an extended period of follow-up of up to 5.5 years, use an effective form of contraception during the first year of enrolment in the study).
- Paediatric groups: Healthy male or female young children aged 2-6 years at the time of enrolment with signed consent obtained from parents or guardians.
- Paediatric groups: completion of the Expanded Programme on Immunisation (EPI) at least 6 months prior to study enrolment.
- Planned long-term (at least 61 months from the date of the first vaccination) or permanent residence in Bagamoyo town.
Key exclusion criteria (24 listed)
- 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).
- Any condition which would place the individual at elevated risk of serious COVID-19 infection, or any other factor which may make the individual eligible for priority COVID-19 vaccination (i.e. ahead of others in their age group).
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChAdOx2 RabGSingle dose of ChAdOx2 RabG at different concentrations: 1x10^10 and 5x10^10 | Biological | Group AC1 (Adult low dose), Group AC2 (Adult high dose), Group AC3 (Adult preferred dose), PC1a (Paediatric low dose), PC1b (Paediatric low dose), PC2 (Paediatric high dose), PC3 (Paediatric preferred dose) |
| Inactivated Rabies VaccineAlso: VerorabA complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units | Biological | Group AC1 (Adult low dose), Group AC2 (Adult high dose), Group AC3 (Adult preferred dose), Group AV1 (Adult single-visit Verobab), PC1a (Paediatric low dose), PC1b (Paediatric low dose), PC2 (Paediatric high dose), PC3 (Paediatric preferred dose), PV1 (Paediatric single-visit Verobab), PV2 (Paediatric two-visit Verobab) |
Primary outcome
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Time frame: Assessment of solicited AEs in the first 7 days post vaccination
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache, fatigue and nausea).
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination
Occurrence of unsolicited local and systemic adverse events
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Time frame: SAEs will be collected from enrolment until the end of the follow-up period (Day 1839)
Occurrence of serious adverse events
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events.
Time frame: Clinical Laboratory AEs to be assessed up to 28 days 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.
2 secondary outcomes
Immunogenicity of ChAdOx2 RabG administered to adults and young children residing in a rabies endemic country following primary vaccination, including the length of response maintenance, and secondary (recall) response.
Time frame: At Days 0, 28, 56, 186, 365, 730, 1095, 1460, 1825
Comparison of immunogenicity of ChAdOx2 RabG with a single visit two site intradermal IRV PrEP regimen
Time frame: At days SPEP+0 and SPEP+7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 42066780Ritchie AJ, Hassan O, Urasa N, Apanga PA, Kimathi R, Kalinga WF, Mtaka IM, Lyimo RG, Shabani MM, Orliacq F, Berg A, Xiang Z, Ahmed S, Athuman T, Ertl HCJ, Olotu A, Douglas AD; RAB002 study team. Safety and immunogenicity of a single-dose adenovirus-vectored rabies vaccine over 1 year in adults and children in Tanzania: interim data from an ongoing, partly randomised, controlled, phase 1b/2 trial. Lancet Infect Dis. 2026 Aug;26(8):843-857. doi: 10.1016/S1473-3099(26)00071-X. Epub 2026 Apr 28.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available on direct request to the Principal Investigator. Proposals will be reviewed by the sponsor, Principal Investigator, and collaborators on the basis of scientific merit. Data will be shared following approval of the proposal and signed data-access agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander D Douglas principal investigator
Jenner Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ChAdOx2 RabG and Inactivated Rabies Vaccine in people with Rabies, run by University of Oxford at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of ChAdOx2 RabG in healthy adult volunteers (18-45 years) and young children (2-6 years) residing in a rabies-endemic country assessed by the occurrence of solicited adverse events. (time frame: Assessment of solicited AEs in the first 7 days post vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.