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

Primary Purpose

Ebola

Status
Active
Phase
Phase 1
Locations
Tanzania
Study Type
Interventional
Intervention
ChAdOx1 biEBOV
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adults aged 18 to 45 years.
  2. Able and willing (in the Investigator's opinion) to comply with all study requirements.
  3. 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.
  4. Agreement to refrain from blood donation while in the study.
  5. Able to read and write
  6. Provide written informed consent.
  7. For women of childbearing potential only: Willingness to practice continuous effective contraception for the duration of the trial
  8. For women of childbearing potential only: A negative pregnancy test on the day of both screening and vaccination.
  9. Long term (at least 6 months) or permanent residence in Bagamoyo district.
  10. Availability through mobile phone 24 hours a day during the whole study period
  11. Agreement to provide personal contact information and contact information of a third party
  12. household member or close friend to study team.

Exclusion Criteria:

  1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment or during the trial follow up period.
  2. Receipt of a recombinant simian adenoviral vaccine prior to enrolment
  3. 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
  4. 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.
  5. Previous receipt of an Ebolavirus vaccine
  6. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  7. 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.
  8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  9. History of hereditary angioedema acquired angioedema, or idiopathic angioedema.
  10. History of anaphylaxis in relation to vaccination.
  11. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
  12. History of serious psychiatric condition likely to affect participation in the study.
  13. Ongoing or planned pregnancy or breastfeeding during the trial follow up period
  14. 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.
  15. 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.
  16. Any other serious chronic illness requiring hospital specialist supervision.
  17. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
  18. Suspected or known injecting drug abuse in the 5 years preceding enrolment.
  19. Detectable circulating hepatitis B surface antigen (HBsAg).
  20. Seropositive for hepatitis C virus (antibodies to HCV).
  21. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
  22. Body mass index (BMI) of <18 or >30 Kg/m2
  23. 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.
  24. 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.

Sites / Locations

  • Bagamoyo Clinical Trial Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^9 vp

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

n=11 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^10 vp

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

Outcomes

Primary Outcome Measures

Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited local reactogenicity signs and symptoms
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited systemic reactogenicity signs and symptoms
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of unsolicited adverse events (AEs)
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of changes from baseline for safety laboratory measures
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of SAEs and AESIs

Secondary Outcome Measures

Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific serological response as measured by ELISA
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific T cell response measured by IFN-γ ELISPOT

Full Information

First Posted
February 24, 2022
Last Updated
February 3, 2023
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT05301504
Brief Title
A Study in Tanzania of a New Vaccine Against Two Types of Ebola
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
n=6 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^9 vp
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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
Arm Title
Group 3
Arm Type
Experimental
Arm Description
n=11 participants vaccinated with a single dose of ChAdOx1 biEBOV 5×10^10 vp
Arm Title
Group 4
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
ChAdOx1 biEBOV
Intervention Description
ChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Primary Outcome Measure Information:
Title
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Description
Occurrence of solicited local reactogenicity signs and symptoms
Time Frame
7 days following vaccination
Title
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Description
Occurrence of solicited systemic reactogenicity signs and symptoms
Time Frame
7 days following vaccination
Title
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Description
Occurrence of unsolicited adverse events (AEs)
Time Frame
28 days following vaccination
Title
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Description
Occurrence of changes from baseline for safety laboratory measures
Time Frame
Days 0, 2, 7, 28
Title
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Description
Occurrence of SAEs and AESIs
Time Frame
Whole duration of the study (~6 months)
Secondary Outcome Measure Information:
Title
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Description
Filovirus GP specific serological response as measured by ELISA
Time Frame
Days 0, 28, 56, 182
Title
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Description
Filovirus GP specific T cell response measured by IFN-γ ELISPOT
Time Frame
Days 0, 7, 14, 28, 56, 128

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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. 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. 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.
Facility Information:
Facility Name
Bagamoyo Clinical Trial Facility
City
Bagamoyo
Country
Tanzania

12. IPD Sharing Statement

Learn more about this trial

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

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