Date: 2015-10-09
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Crucell Holland, a J&J company (USA - NJ)
Product: Ad26.ZEBOV and MVA-BN-Filo
Action
mechanism: vaccine
Disease: Ebola fever
Therapeutic area: Infectious diseases
Country: Sierra Leone
Trial
details: EBOVAC-Salone is a clinical trial to assess the safety and immunogenicity of an Ebola prime-boost vaccine regimen among adults, adolescents and children in Sierra Leone who volunteer to participate. Volunteers are planned to enroll in the study at different stages over the course of several months. The purpose of this study is the evaluation of the safety and immunogenicity, during the implementation of Stages 1-2, and the effectiveness during Stage 3, of two candidate Ebola vaccines Ad26.ZEBOV and MVA-BN-Filo, in a heterologous prime-boost regimen. The initial implementation considers Stages 1-2 and depending on the Ebola outbreak evolution, vaccine effectiveness will be considered in Stage 3. In stage 1 of the study, approximately 40 adults aged 18 years or older will be vaccinated to gain information about the safety and immunogenicity (immune response) of the prime-boost regimen. In stage 2, a larger group of approximately 400 individuals will be vaccinated to further evaluate the safety and immunogenicity of the vaccine regimen across different age groups. In this stage, adolescents and children will be included. Additional stages are being finalized in consultation with the Sierra Leonean authorities and international health agencies. (NCT02509494)
Latest
news: * On October 9, 2015, Johnson & Johnson announced the start of a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. This is the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic. The new study, EBOVAC-Salone, will take place in Sierra Leone’s Kambia district, where some of the country’s most recent Ebola cases have been reported. The regimen being tested uses a combination of two vaccine components based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and MVA-BN® technology from Bavarian Nordic. Volunteers in the study will first be given the AdVac dose to prime their immune system, and then the MVA-BN dose two months later to boost their immune response, with the goal of potentially strengthening and optimizing the duration of the immunity. The EBOVAC-Salone study will evaluate the vaccine regimen’s safety and immune response within the general population of Sierra Leone, including vulnerable groups such as adolescents, children, and people with HIV. In addition to the London School of Hygiene & Tropical Medicine which is coordinating the EBOVAC-Salone trial, Janssen is partnering with Sierra Leone’s Ministry of Health and Sanitation, the College of Medicine and Allied Health Sciences, and two consortia of which Janssen is a member that are funded by Europe’s Innovative Medicines Initiative (IMI): EBOVAC1 (Ebola Vaccine Development), which is conducting the study, and EBODAC (Ebola Vaccine Deployment, Acceptance & Compliance), which is developing a communication strategy and tools to promote the acceptance and uptake of the Ebola vaccine regimen. From the outset, the EBOVAC-Salone team’s goal has been to conduct a study that meets Sierra Leone\'s Ebola prevention needs, has the support of the Sierra Leonean people, and can play a sustaining role in helping to restore the country\'s health infrastructure following the Ebola outbreak. Significant investment has been made to build new facilities in Kambia to conduct the study, which will contribute substantially to the strengthening of the local health system. These include establishing the first Emergency Room at the Kambia District Hospital, and building a new vaccine storage facility on the hospital site. These efforts are complemented by the employment and training of doctors, nurses and other frontline health care workers who will gain valuable experience while contributing to the clinical study. The EBOVAC-Salone study is being initiated on a parallel track with multiple ongoing Phase I and II studies that are being conducted across the U.S., Europe and Africa as part of the accelerated development plan for the Ebola vaccine regimen. First-in-human Phase I clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in January 2015, followed by several sites in Africa. In May 2015, Johnson & Johnson presented promising preliminary data from the UK Phase I study to the FDA. A Phase II study, being carried out in the UK and France, started in July 2015, and a second multi-site Phase II study will shortly commence in several West and East African countries in outside epidemic areas. These Phase II studies are being coordinated by Institut National de la Sante et de la Recherche Medicale (Inserm), another consortium partner with Janssen. In January 2015, Europe’s Innovative Medicines Initiative (IMI) awarded a consortia of leading global research institutions and non-government organizations working in conjunction with the Janssen Pharmaceutical Companies grants totaling more than €100 million from the Ebola+ programme to support the development, manufacturing and deployment of the vaccine regimen. Janssen’s EBOVAC1 and EBODAC consortia partners also include the University of Oxford, Inserm, Grameen Foundation and World Vision of Ireland. The Innovative Medicines Initiative 2 Joint Undertaking is under grant agreement EBOVAC1 (grant nr. 115854) and EBODAC (grant nr. 115847), part of the Ebola+ program launched in response to the Ebola virus disease outbreak. This IMI2 Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA).
