UnknownPhase 1

A Study in Tanzania of a New Vaccine Against Two Types of Ebola

Tanzania76 participantsStarted 2022-03-30

Plain-language summary

An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 7 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 7 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 28 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: Days 0, 2, 7, 28

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: Whole duration of the study (~6 months)

Trial details

NCT IDNCT05301504

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Ebola trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 7 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 7 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: 28 days following vaccination

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: Days 0, 2, 7, 28

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.

Timeframe: Whole duration of the study (~6 months)