EbolaPhase 1NCT05301504
A Study in Tanzania of a New Vaccine Against Two Types of Ebola
A Phase 1 study testing ChAdOx1 biEBOV in people with Ebola, run by University of Oxford at 1 site in Tanzania.
Trial summary
An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola
- What is being tested?
- ChAdOx1 biEBOV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTanzania
- Study dates
- 30 Mar 2022to Dec 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 45 years.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study clinician for physical examination and any other clinical investigations.
- Agreement to refrain from blood donation while in the study.
- Able to read and write
- Provide written informed consent.
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- For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial
- For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
- Long term (at least 6 months) or permanent residence in Bagamoyo district.
- Availability through mobile phone 24 hours a day during the whole study period
- Agreement to provide personal contact information and contact information of a third party
- household member or close friend to study team.
Who cannot join
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
- Receipt of a recombinant simian adenoviral vaccine prior to enrolment
- Planned receipt of another adenoviral vectored vaccine (e.g., Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV
- Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
- Previous receipt of an Ebolavirus vaccine
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
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- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) systemically active immunosuppressant medication within the past 6 months.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of hereditary angioedema acquired angioedema, or idiopathic angioedema.
- History of anaphylaxis in relation to vaccination.
- 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.
- Ongoing or planned pregnancy or breastfeeding during the trial follow up period
- Known 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.
- History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), known history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia.
- Any other serious chronic illness requiring hospital specialist supervision.
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Detectable circulating hepatitis B surface antigen (HBsAg).
- Seropositive for hepatitis C virus (antibodies to HCV).
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
- Body mass index (BMI) of <18 or >30 Kg/m2
- 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.
- Acute disease at the time of administration of the IMP (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e., axillary temperature < 37.5°C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study to Determine the Safety and Immunogenicity of a Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in Tanzanian Healthy Adult Volunteers
An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial
Read the detailed description
This is an open label, first in human, dose escalation, phase Ib clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy Tanzanian volunteers aged 18-45. The vaccine will be administered intramuscularly (IM). There will be 4 study groups and it is anticipated that a total of 76 volunteers will be enrolled. Dose escalation and sentinel participant procedures will be implemented. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially allocated to a study group by selecting eligible volunteers for enrolment following screening. Sequential allocation will occur based on the order in which volunteers are enrolled. Group 4 will be recruited last, with dose selection being dependent on completion of groups 1-3 and a review of safety data.
The trial is funded by Innovate UK project reference 971615.
- Conditions
- Ebola
- Being tested
- ChAdOx1 biEBOV
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1 biEBOVBiological
ChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^9 vp Receives: Biological: ChAdOx1 biEBOV |
| Group 2 | Experimental | n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5×10^10 vp
Note: The DSMB may recommend increasing the size of group 2 to n=9 in the event of higher than expected reactogenicity Receives: Biological: ChAdOx1 biEBOV |
| Group 3 | Experimental | n=11 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^10 vp Receives: Biological: ChAdOx1 biEBOV |
| Group 4 | Experimental | n=25 participants vaccinated with a two doses of ChAdOx1 biEBOV at the final selected dose, based on safety data for groups1-3. The second dose is administered after 12 weeks.
Note:The dose for group 4 will be selected following a review of safety data to 28 days post vaccination for all previous participants (groups 1 to 3 Receives: Biological: ChAdOx1 biEBOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited local reactogenicity signs and symptoms
Measured: 7 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited systemic reactogenicity signs and symptoms
Measured: 7 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of unsolicited adverse events (AEs)
Measured: 28 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of changes from baseline for safety laboratory measures
Measured: Days 0, 2, 7, 28
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of SAEs and AESIs
Measured: Whole duration of the study (~6 months)
Secondary outcomes (2)
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific serological response as measured by ELISA
Measured: Days 0, 28, 56, 182
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific T cell response measured by IFN-γ ELISPOT
Measured: Days 0, 7, 14, 28, 56, 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start30 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EbolaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301504
- Sponsor's protocol ID
- EBL08
- Status last verified
- Nov 2022
- First submitted
- 24 Feb 2022
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Determine the Safety and Immunogenicity of a Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in Tanzanian Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05301504
- Acronym / sponsor ID
- EBL08
- Conditions
- Ebola
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Mar 2022 (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.
An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial
Detailed description
This is an open label, first in human, dose escalation, phase Ib clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy Tanzanian volunteers aged 18-45. The vaccine will be administered intramuscularly (IM). There will be 4 study groups and it is anticipated that a total of 76 volunteers will be enrolled. Dose escalation and sentinel participant procedures will be implemented. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially allocated to a study group by selecting eligible volunteers for enrolment following screening. Sequential allocation will occur based on the order in which volunteers are enrolled. Group 4 will be recruited last, with dose selection being dependent on completion of groups 1-3 and a review of safety data.
The trial is funded by Innovate UK project reference 971615.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ChAdOx1 biEBOVn=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^9 vp |
| Group 2 | Experimental | Biological: ChAdOx1 biEBOVn=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 2.5×10^10 vp Note: The DSMB may recommend increasing the size of group 2 to n=9 in the event of higher than expected reactogenicity |
| Group 3 | Experimental | Biological: ChAdOx1 biEBOVn=11 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^10 vp |
| Group 4 | Experimental | Biological: ChAdOx1 biEBOVn=25 participants vaccinated with a two doses of ChAdOx1 biEBOV at the final selected dose, based on safety data for groups1-3. The second dose is administered after 12 weeks. Note:The dose for group 4 will be selected following a review of safety data to 28 days post vaccination for all previous participants (groups 1 to 3 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adults aged 18 to 45 years.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study clinician for physical examination and any other clinical investigations.
- Agreement to refrain from blood donation while in the study.
- Able to read and write
Key exclusion criteria (24 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
- Receipt of a recombinant simian adenoviral vaccine prior to enrolment
- Planned receipt of another adenoviral vectored vaccine (e.g., Oxford/AstraZeneca or Janssen COVID-19 vaccines) within 90 days after the vaccination with the ChAdOx1 biEBOV
- Planned or actual receipt of any vaccines administered within 30 days (before or after) enrolment and/or planned receipt of a vaccine ≤30 days after enrolment EXCEPT for protein, RNA (or other non-adenovirus based) COVID-19 vaccinations which may be given within 14 days of the trial vaccine.
- Previous receipt of an Ebolavirus 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 |
|---|---|---|
| ChAdOx1 biEBOVChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably) | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Time frame: 7 days following vaccination
Occurrence of solicited local reactogenicity signs and symptoms
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Time frame: 7 days following vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Time frame: 28 days following vaccination
Occurrence of unsolicited adverse events (AEs)
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Time frame: Days 0, 2, 7, 28
Occurrence of changes from baseline for safety laboratory measures
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Time frame: Whole duration of the study (~6 months)
Occurrence of SAEs and AESIs
2 secondary outcomes
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Time frame: Days 0, 28, 56, 182
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Time frame: Days 0, 7, 14, 28, 56, 128
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ChAdOx1 biEBOV in people with Ebola, 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 12 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 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?
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?
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers. (time frame: 7 days following vaccination). The study lists 5 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 8 Feb 2023.