Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine

Summary

Background: Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. Objectives: To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how it affects people's immune system. Eligibility: \- Healthy men and women ages 18-65. They must not have a chronic medical condition that requires medicine. They must not be a healthcare worker, an animal care worker, or a childcare worker, and they must not have a household contact that has a compromised immune system, is pregnant, or is under the age of 5 years. Design: * Participants will be screened with medical history, physical exam, and blood tests. * Participants will be randomly assigned to get the vaccine or the placebo. * At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine or placebo will be injected into the upper arm muscle. * Participants will return to the clinic 11 times over the next 6 months. Participants will have blood drawn at every study visit. Their mouth will be swabbed and urine tested at least four times after vaccination. * For 14 days after vaccination, participants will write down their temperature, any symptoms, and any redness at the injection site. They will bring the booklet to each study visit. All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health Centre, Halifax, NS.

Timeline

Start

2014-11

Primary completion

2015-03

Completion

2015-06

Publications

• Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
• ElSherif MS, Brown C, MacKinnon-Cameron D, Li L, Racine T, Alimonti J, Rudge TL, Sabourin C, Silvera P, Hooper JW, Kwilas SA, Kilgore N, Badorrek C, Ramsey WJ, Heppner DG, Kemp T, Monath TP, Nowak T, McNeil SA, Langley JM, Halperin SA; Canadian Immunization Research Network. Assessing the safety and immunogenicity of recombinant vesicular stomatitis virus Ebola vaccine in healthy adults: a randomized clinical trial. CMAJ. 2017 Jun 19;189(24):E819-E827. doi: 10.1503/cmaj.170074.

Drugs

Indications