Active clinical trials for "Hemorrhagic Fever, Ebola"

The purpose of this study is to evaluate the safety and tolerability of healthy male and female subjects with intravenous (IV) infusions of AVI 7537 compared to matched placebo in and to evaluate the pharmacokinetics (PK).

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.

The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.

LA rVSVΔG-ZEBOV-GP -02-PED is a Phase 1/2, randomized, controlled open label trial. The LA rVSVΔG-ZEBOV-GP -02-PED trial aims primarily to assess the clinical significance of shedding of the rVSV RNA following vaccination with the rVSVΔG-ZEBOV-GP vaccine in children. The vaccine doses of ≥7.8 x 107 pfu will be evaluated and compared to vaccination with varicella vaccine as a control. In addition, the closest contact persons of the vaccinees will be monitored for possible transmission of the viral vaccine vector. The study will enroll children of two age groups living in Lambaréné, Gabon. Children will be followed-up for 12 months post vaccination. The 1-2 closest contact persons of each participant will be involved in the monitoring of rVSV transmission. They will be followed until day 56 post- vaccination of their children/ sibling.

The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose

Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers [e.g., individuals who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x 10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine. Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or placebo. This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects (Uganda) and North American subjects (NIH, Bethesda, MD, USA). Objectives: To see if an Ebola vaccine is safe and to study immune responses to it. To study the effect of the MVA-EbolaZ booster on the immune response Eligibility: - Healthy adults ages 18-65.

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.

This is a randomized, observer-blind, placebo-controlled trial in male and female subjects ≥18 to <50 years of age. Subjects will be healthy adults based on history, physical examination, and baseline clinical laboratory testing. Approximately 230 eligible subjects will be enrolled into 1 of 13 treatment groups. Treatments will comprise two IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids with the test article assigned (i.e., saline placebo, dose of EBOV GP vaccine with or without Matrix-M adjuvant), in a 0.5mL injection volume.