RabiesPhase 1NCT04162600
Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG
A Phase 1 study testing ChAdOx2 RabG and Inactivated Rabies Vaccine in people with Rabies, run by University of Oxford at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 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, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2020to 10 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- 13. Individuals who have previously experienced episodes of capillary leak syndrome.
- 14. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism).
- 15. History of antiphospholipid syndrome. 16. History of prior receipt of unfractionated heparin. 17. History of heparin induced thrombocytopenia. 18. Any other serious chronic illness requiring hospital specialist supervision.
- 19. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week. 20. Suspected or known injecting drug abuse in the 5 years preceding enrolment. 21. Detectable circulating hepatitis B surface antigen (HBsAg). 22. Seropositive for hepatitis C virus (antibodies to HCV). 23. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis. 24. Any other significant disease, disorder or finding 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.
- 25. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate. 26. Receipt of any prior rabies vaccine, including an incomplete course. 27. Require or will require rabies vaccination during the first 8 weeks of the study period (e.g. through planned travel to high risk enzootic areas of through work which may lead to exposure and for which rabies vaccination is usually required/recommended).
- Receiving rabies vaccination following the completion of the first 8 weeks of follow-up but before the optional extended follow-up period will exclude participants from taking part in the optional follow-up period.
- History of allergic reactions to amphotericin B, chlortetracycline, neomycin, polymyxin, streptomycin, or to any antibiotics of the same groups will exclude participants from receiving certain IRVs (as per the relevant SmPC) during the optional extended follow-up period, but will not exclude participants from receiving ChAdOx2 RabG.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
CCVTM, University of Oxford, Churchill Hospital
Oxford, OX3 7LE
About this study
Official title: A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG in UK Healthy Adult Volunteer
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).
Read the 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.
- 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: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
Inactivated Rabies VaccineBiological
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
ChAdOx2 RabGBiological
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
ChAdOx2 RabGBiological
Single dose of ChAdOx2 RabG at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp.
Inactivated Rabies VaccineBiological
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
Inactivated Rabies VaccineBiological
A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units.
| Study group | Role | What they receive |
|---|---|---|
| 5 x 10^9 vp of ChAdOx2 RabG | Experimental | 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. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| 2.5 x 10^10 vp of ChAdOx2 RabG | Experimental | 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. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
| 5 x 10^10 vp of ChAdOx2 RabG | Experimental | 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. Receives: Biological: ChAdOx2 RabG; Biological: Inactivated Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses 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 and tolerability of ChAdOx2 RabG in healthy volunteers given as a standalone vaccine at different doses assessed 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.(8 weeks)
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.
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: At Day 0 (baseline), day 2, day 7, day 28 and day 56 post vaccination
Secondary outcomes (1)
Immunogenicity of the ChAdOx2 RabG vaccine
Rapid fluorescent focus inhibition test (RFFIT) of virus neutralising antibody
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start2 Jan 2020
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Why it 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).
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162600
- Sponsor's protocol ID
- RAB001
- Status last verified
- Jul 2024
- First submitted
- 11 Nov 2019
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jenkin D, Ritchie AJ, Aboagye J, Fedosyuk S, Thorley L, Provstgaad-Morys S, Sanders H, Bellamy D, Makinson R, Xiang ZQ, Bolam E, Tarrant R, Ramos Lopez F, Platt A, Poulton I, Green C, Ertl HCJ, Ewer KJ, Douglas AD. Safety and immunogenicity of a simian-adenovirus-vectored rabies vaccine: an open-label, non-randomised, dose-escalation, first-in-human, single-centre, phase 1 clinical trial. Lancet Microbe. 2022 Sep;3(9):e663-e671. doi: 10.1016/S2666-5247(22)00126-4. Epub 2022 Jul 27.
PubMed 35907430
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Rabies Vaccine ChAdOx2 RabG in UK Healthy Adult Volunteer
- ClinicalTrials.gov ID
- NCT04162600
- Acronym / sponsor ID
- RAB001
- Conditions
- Rabies
- Keywords
- Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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).
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 14 Nov 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 x 10^9 vp of ChAdOx2 RabG | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers 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. |
| 2.5 x 10^10 vp of ChAdOx2 RabG | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers 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. |
| 5 x 10^10 vp of ChAdOx2 RabG | Experimental | Biological: ChAdOx2 RabG, Biological: Inactivated Rabies VaccineVolunteers 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp | Biological | 2.5 x 10^10 vp of ChAdOx2 RabG |
| Inactivated Rabies VaccineA complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units. | Biological | 2.5 x 10^10 vp of ChAdOx2 RabG |
| ChAdOx2 RabGSingle dose of ChAdOx2 RabG at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp | Biological | 5 x 10^10 vp of ChAdOx2 RabG |
| ChAdOx2 RabGSingle dose of ChAdOx2 RabG at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp. | Biological | 5 x 10^9 vp of ChAdOx2 RabG |
| Inactivated Rabies VaccineA complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units. | Biological | 5 x 10^10 vp of ChAdOx2 RabG |
| Inactivated Rabies VaccineA complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units. | Biological | 5 x 10^9 vp of ChAdOx2 RabG |
Primary outcome
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: 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 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: Unsolicited AEs to be assessed up to 28 days post vaccination.
Occurrence of unsolicited local and systemic adverse events
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
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.
1 secondary outcome
Immunogenicity of the ChAdOx2 RabG vaccine
Time frame: Day 365
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 35907430Jenkin D, Ritchie AJ, Aboagye J, Fedosyuk S, Thorley L, Provstgaad-Morys S, Sanders H, Bellamy D, Makinson R, Xiang ZQ, Bolam E, Tarrant R, Ramos Lopez F, Platt A, Poulton I, Green C, Ertl HCJ, Ewer KJ, Douglas AD. Safety and immunogenicity of a simian-adenovirus-vectored rabies vaccine: an open-label, non-randomised, dose-escalation, first-in-human, single-centre, phase 1 clinical trial. Lancet Microbe. 2022 Sep;3(9):e663-e671. doi: 10.1016/S2666-5247(22)00126-4. Epub 2022 Jul 27.
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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 study testing ChAdOx2 RabG and Inactivated Rabies Vaccine in people with Rabies, run by University of Oxford at 1 site in United Kingdom.
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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 8 Nov 2024. 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 United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
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 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: 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 NCT04162600, 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 8 Nov 2024.