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

NCT05301504 | Unknown Phase 1 DMC

• 1 other identifier: EBL08
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ebola

Outcome Measures

Primary Outcomes (5)

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

  Occurrence of solicited local reactogenicity signs and symptoms

  7 days following vaccination

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

  Occurrence of solicited systemic reactogenicity signs and symptoms

  7 days following vaccination

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

  Occurrence of unsolicited adverse events (AEs)

  28 days following vaccination

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

  Occurrence of changes from baseline for safety laboratory measures

  Days 0, 2, 7, 28

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

  Occurrence of SAEs and AESIs

  Whole duration of the study (~6 months)

Secondary Outcomes (2)

• Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.

  Days 0, 28, 56, 182

• Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.

  Days 0, 7, 14, 28, 56, 128

Study Arms (4)

Group 1

EXPERIMENTAL

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

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

Biological: ChAdOx1 biEBOV

Group 3

EXPERIMENTAL

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

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

Biological: ChAdOx1 biEBOV

Interventions

ChAdOx1 biEBOV BIOLOGICAL

ChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Bagamoyo Clinical Trial Facility

Bagamoyo, Tanzania

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 29, 2022
• Study Start: March 30, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-11

Locations

TA (1)