RabiesPhase 2NCT07168018
Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine
A Phase 2 study testing Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) and Inactivated Rabies Vaccine (IRV) in people with Rabies, run by University of Oxford at 1 site in Tanzania.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) and Inactivated Rabies Vaccine (IRV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTanzania
- Study dates
- Dec 2025to Mar 2026
- Phase
- Phase 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
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).
- 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
- Any history of anaphylaxis in relation to vaccination.
Show all 23Show fewer
- Clinically significant laboratory abnormality as judged by the PI or other delegated individual.
- Receipt of any previous rabies vaccinations, including an incomplete course of IRV and/or any doses of ChAdOx2 RabG.
- 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. Contact the study team or a site near you to ask about taking part.
Tanzania1 site
Ifakara Health Institute
Bagamoyo
Omary Hassan, +255719356691, ohassan@ihi.or.tz
Ally Olotu, aolotu@ihi.or.tz
About this study
Official title: A Phase II Randomised, Open-label Study of the Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine
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).
Read the detailed description
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.
- Conditions
- Rabies
- Being tested
- Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV), Inactivated Rabies Vaccine (IRV)
- 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.
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).
Inactivated Rabies Vaccine (IRV)Biological
Also called Verorab
A World Health Organization (WHO) prequalified IRV at two anatomical sites (2 site ID) on days 0, 3 and 7.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) |
| 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. Receives: Biological: Inactivated Rabies Vaccine (IRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: SAEs will be collected from enrolment until the end of the follow-up period (Day 56).
Secondary outcomes (1)
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).
Measured: Rabies virus neutralisation antibody titres will be determined at baseline and days 7, 14, 21, 28, and 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startDec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander D Douglas, Principal investigator, Jenner Institute, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168018
- Sponsor's protocol ID
- RAB003
- Status last verified
- Oct 2025
- First submitted
- 4 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 II Randomised, Open-label Study of the Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine
- ClinicalTrials.gov ID
- NCT07168018
- Acronym / sponsor ID
- RAB003
- Conditions
- Rabies
- Keywords
- Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 Sep 2025 (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 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A1 (Adults) | Experimental | Biological: Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV)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. |
| Group A2 (Adults) | Active comparator | Biological: Inactivated Rabies Vaccine (IRV)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (23 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).
- 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
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 |
|---|---|---|
| Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV)A single visit of coadministration of 5×10^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM). | Biological | Group A1 (Adults) |
| Inactivated Rabies Vaccine (IRV)Also: VerorabA World Health Organization (WHO) prequalified IRV at two anatomical sites (2 site ID) on days 0, 3 and 7. | Biological | Group A2 (Adults) |
Primary outcome
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.
Time frame: Assessment of solicited AEs in the first 7 days post vaccination
Occurrence of local and systemic solicited AEs
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.
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination
Occurrence of unsolicited local and systemic adverse events
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.
Time frame: Clinical laboratory AEs to be assessed up to 28 days post vaccination.
Occurrence of laboratory adverse events.
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.
Time frame: SAEs will be collected from enrolment until the end of the follow-up period (Day 56).
Occurrence of serious adverse events
1 secondary outcome
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.
Time frame: Rabies virus neutralisation antibody titres will be determined at baseline and days 7, 14, 21, 28, and 56.
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.
Related trials for Rabies
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Active, not recruitingPhase 3
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Rabies Post-exposure Prophylaxis, Rabies
RecruitingObservational study
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Rabies Post-exposure Prophylaxis
Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
Rabies Prevention
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.
Alexander D Douglas principal investigator
Jenner Institute, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) and Inactivated Rabies Vaccine (IRV) 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 9 inclusion and 23 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: opening soon, 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 phase mean?
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?
Contact Paschal Apanga (+441865 617624, paschal.apanga@ndm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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?
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.