A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland

NCT ID: NCT02289027

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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The objective of this trial is to assess in healthy adults the safety and reactogenicity of a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the immunogenicity of the candidate vaccine and find the most suitable dose for further deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of possibly exposed volunteers owning to organisations such as "Médecins sans frontières" and susceptible to be deployed in the outbreak zone (named as "possibly exposed volunteers"). The other volunteers will be adults with no planned travels to the epidemic zone (named as "not exposed volunteers"). The first group will be randomly allocated to two different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp). The second group will be randomly allocated to three different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.

Detailed Description

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Conditions

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Ebola Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Deployed volunteers - Group 1

Low dose cAd3-EBOZ (2.5x10e10 vp)

Group Type EXPERIMENTAL

cAd3-EBOZ vaccine

Intervention Type BIOLOGICAL

Deployed volunteers - Group 2

High dose cAd3-EBOZ (5x10e10 vp)

Group Type EXPERIMENTAL

cAd3-EBOZ vaccine

Intervention Type BIOLOGICAL

Not deployed volunteers - Group 3

Low dose cAd3-EBOZ (2.5x10e10 vp)

Group Type EXPERIMENTAL

cAd3-EBOZ vaccine

Intervention Type BIOLOGICAL

Not deployed volunteers - Group 4

High dose cAd3-EBOZ (5x10e10 vp)

Group Type EXPERIMENTAL

cAd3-EBOZ vaccine

Intervention Type BIOLOGICAL

Not deployed volunteers - Group 5

Group Type PLACEBO_COMPARATOR

Placebo (for cAd3-EBOZ vaccine)

Intervention Type BIOLOGICAL

Diluent

Interventions

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cAd3-EBOZ vaccine

Intervention Type BIOLOGICAL

Placebo (for cAd3-EBOZ vaccine)

Diluent

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy adults aged 18 to 65 years
2. Able and willing (in the Investigator's opinion) to comply with all study requirements
3. Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner
4. For females of reproductive capacity and males, having practiced continuous effective contraception for 21 days prior to enrolment, and willing to practice continuous effective contraception for 3 months post vaccination
5. For females of reproductive capacity, having a negative pregnancy test on the day(s) of screening and vaccination if \>7 days interval
6. Agreement to refrain from blood donation during the course of the study
7. Provide written informed consent

Exclusion Criteria

1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
2. Prior receipt of an investigational Ebola or Marburg vaccine or a chimpanzee adenovirus vectored vaccine
3. Receipt of any live, attenuated vaccine within 28 days prior to enrolment
4. Receipt of any subunit or killed vaccine within 14 days prior to enrolment (influenza vaccination is encouraged prior to participation)
5. Receipt of any investigational vaccine within 3 months prior to enrollment
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 immunosuppressed or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressive medication within the past 6 months (inhaled and topical steroids are allowed)
8. History of allergic reactions likely to be exacerbated by any component of the vaccine,
9. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
10. Any history of anaphylaxis in reaction to vaccination
11. Pregnancy, lactation or willingness/intention to become pregnant during the study
12. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
13. History of serious psychiatric condition
14. Poorly controlled asthma or thyroid disease
15. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years
16. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
17. Any other serious chronic illness requiring hospital specialist supervision
18. Current anti-tuberculosis prophylaxis or therapy
19. Suspected or known current alcohol abuse
20. Suspected or known injecting drug abuse in the 5 years preceding enrolment
21. Seropositive for hepatitis B surface antigen (HBsAg)
22. Seropositive for hepatitis C virus (antibodies to HCV)
23. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
24. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Infectious Disease Service, CHUV, Lausanne

UNKNOWN

Sponsor Role collaborator

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Immunology and Allergy Service, CHUV, Lausanne

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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François Spertini

Head physician Immunology and Allergy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blaise Genton, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHUV and PMU

Locations

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Clinical Trial Unit Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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De Santis O, Audran R, Pothin E, Warpelin-Decrausaz L, Vallotton L, Wuerzner G, Cochet C, Estoppey D, Steiner-Monard V, Lonchampt S, Thierry AC, Mayor C, Bailer RT, Mbaya OT, Zhou Y, Ploquin A, Sullivan NJ, Graham BS, Roman F, De Ryck I, Ballou WR, Kieny MP, Moorthy V, Spertini F, Genton B. Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study. Lancet Infect Dis. 2016 Mar;16(3):311-20. doi: 10.1016/S1473-3099(15)00486-7. Epub 2015 Dec 23.

Reference Type DERIVED
PMID: 26725450 (View on PubMed)

Other Identifiers

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cAd3-EBOZ Lau

Identifier Type: -

Identifier Source: org_study_id

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