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

Summary

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.

Conditions

• Ebola Vaccines

Interventions

BIOLOGICAL

cAd3-EBOZ vaccine

BIOLOGICAL

Placebo (for cAd3-EBOZ vaccine)

Diluent

Sponsors & Collaborators

• Infectious Disease Service, CHUV, Lausanne

  collaborator UNKNOWN

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

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• University of Lausanne

  collaborator OTHER

• GlaxoSmithKline

  collaborator INDUSTRY

• World Health Organization

  collaborator OTHER

• Immunology and Allergy Service, CHUV, Lausanne

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Vaudois

  lead OTHER

Principal Investigators

• Blaise Genton, MD PhD · CHUV and PMU

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• Switzerland

Study Locations