Phase 1
N=40
Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination
Ebola Virus Disease
Bottom Line
View on ClinicalTrials.gov: NCT02485912 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events. — 20; 20 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ChAd3-EBO Z (Biological); MVA-EBO Z (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oxford
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events. |
20; 20 | — |
| SECONDARY To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years |
20; 20 | — |
Summary
This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen.
All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8 pfu.
All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later.
The site of administration of the MVA-EBO Z vaccine differs between the two groups:
Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine.
Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples.
The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it.
Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.
Eligibility Criteria
Inclusion Criteria
- Healthy adults aged 18 to 50 years
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- For females only, willingness to practice continuous effective contraception (see section 6.4.3) during the study and a negative pregnancy test on the day(s) of screening and vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Exclusion Criteria
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned participation during the study period
- Prior receipt of an investigational Ebola or Marburg vaccine, a chimpanzee adenovirus vectored vaccine, an MVA vaccine or any other investigational vaccine likely to impact on interpretation of the trial data
- Receipt of any live, attenuated vaccine within 28 days prior to enrolment
- Receipt of any subunit or killed vaccine within 14 days prior to enrolment
- 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, (e.g. egg products) including urticaria, respiratory difficulty or abdominal pain
- Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- Any history of anaphylaxis in reaction 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 current or previous psychiatric illness.
- Poorly controlled asthma or thyroid disease
- Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
- Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- Any other serious chronic illness
- Current anti-tuberculosis prophylaxis or therapy
- 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
- Seropositive for hepatitis B surface antigen (HBsAg)
- History of contact with suspected, probable or confirmed cases of Ebola in the previous 21 days
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Appendix A & B)
- 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
Data sourced from ClinicalTrials.gov (NCT02485912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.