Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination

NCT02485912 | Completed Phase 1 Results

• 1 other identifier: EBL06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ebola Virus Disease

Keywords

Ebola; vaccine; safety; immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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.

  The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed for both groups: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination * Occurrence of unsolicited adverse events for 28 days following the vaccination * Change from baseline for safety laboratory measures * Occurrence of serious adverse events during the whole study duration

  26 weeks

Secondary Outcomes (1)

• 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

  26 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. Both vaccinations are administered in the same arm.

Biological: ChAd3-EBO Z; Biological: MVA-EBO Z

Group 2

ACTIVE COMPARATOR

ChAd3-EBO Z (2.5 - 3.7 x 10\^10 vp) and MVA-EBO Z (1.0 x 10\^8 pfu) 7 days later. The MVA-EBO Z is administered in the opposite arm to the ChAd3-EBO Z.

Biological: ChAd3-EBO Z; Biological: MVA-EBO Z

Interventions

ChAd3-EBO Z BIOLOGICAL

This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein

Group 1; Group 2

MVA-EBO Z BIOLOGICAL

This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal: collaborator

Study Sites (1)

Centre Hospitalier Universitaire le Dantec

Dakar, BP 7325, Senegal

Location

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MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Adrian V Hill, DPhil FRCP
• Organization: University of Oxford

vaccinetrials@ndm.ox.ac.uk

Study Officials

• Souleymane Mboup, MD; PhD

  Centre Hospitalier Universitaire le Dantec (CHUD), Dakar, Senegal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 30, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 6, 2019
• Results First Posted: February 6, 2019

Record last verified: 2016-02

Locations

SE (1)