Open Study of the Duration of Immunity After Vaccination With GamEvac

2016-09-22 20:53:27 | BioPortfolio


The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvacVector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.


This clinical trial is designed as an open study to evaluate the duration of immunity persistence following the administration of medicinal product GamEvac Vector-Based Vaccine against Ebola Virus Disease.

It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure specified in this Protocol. Only those patients who have signed the information consent form for participation in the study and have been informed by physician on the objectives and methods of this project will be involved in the study.

The study consists of a single stage which is designed as a follow-up period to observe volunteers vaccinated in the course of evaluation of safety, reactogenic properties and immunogenicity of product GamEvac Vector-Based Vaccine against Ebola Virus Disease in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 02-E-2015 in October-November 2015. Vaccination will not be made within the present study. Screening of volunteers is not required: the study will involve as many of the volunteers as possible (but not more than 60 subjects) who had been immunized earlier with GamEvac Vector-Based Vaccine against Ebola Virus Disease, provided that they have no medical contraindications for blood sampling.

Study Schedule Visit 1 (outpatient): the goal of this visit is to assess whether a patient meets the inclusion/exclusion criteria. All procedures should be carried out upon receipt of the informed consent form signed by patient. The visit will be held 12 months after the vaccination.

Visit 2 (outpatient): 18 months after the vaccination. Visit 3 (outpatient): 24 months after the vaccination. The duration of immunity persistence following product administration will be assessed in healthy volunteers based on the measurements of specific antibody titers.

by ELISA method 12, 18 and 24 months after the vaccination vs. baseline values; in virus neutralization reaction 12 months after the vaccination vs. baseline values.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Ebola Hemorrhagic Fever


blood sampling collection


Not yet recruiting


Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Results (where available)

View Results


Published on BioPortfolio: 2016-09-22T20:53:27-0400

Clinical Trials [801 Associated Clinical Trials listed on BioPortfolio]

Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi

The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of prod...

Experimental Ebola Vaccine Trial

This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The E...

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever

To provide an intravenous ribavirin therapeutic option for patients with a probable or suspected case of viral hemorrhagic fever, specifically Crimean-Congo hemorrhagic fever or Lassa feve...

Evaluating the Safety of and Immune Response to a Human Parainfluenza Virus Type 3 Ebola Virus Vaccine (HPIV3-EbovZ GP) in Healthy Adults

The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of the HPIV3-EbovZ GP Ebola vaccine candidate in healthy adults.

STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)

The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood an...

PubMed Articles [11129 Associated PubMed Articles listed on BioPortfolio]

Beyond Ebola: surveillance for all hemorrhagic fever in West Africa should be enhanced.

Hospital Preparations for Viral Hemorrhagic Fever Patients and Experience Gained from Admission of an Ebola Patient.

The Major Incident Hospital of the University Medical Centre of Utrecht has a longstanding history of preparing for the management of highly pathogenic and infectious organisms. An assessment of the h...

A retrospective controlled study of thiol disulfide homeostasis as a novel marker in Crimean Congo hemorrhagic fever.

Crimean Congo hemorrhagic fever (CCHF) is the second most common hemorrhagic fever worldwide. This study aimed to evaluate the oxidant-antioxidant balance of patients with CCHF by detecting dynamic th...

Diagnostic Yield of Timing Blood Culture Collection Relative to Fever.

Conventional practice involves obtaining a blood culture during or immediately following a fever to increase diagnostic yield. There are no data to support this practice in children.

Crimean-Congo hemorrhagic fever virus in livestock ticks and animal handler seroprevalence at an abattoir in Ghana.

Crimean-Congo Haemorrhagic Fever Virus (CCHFV) is a zoonotic virus transmitted by Ixodid ticks and causes Crimean-Congo hemorrhagic fever (CCHF) disease in humans with up to 50 % mortality rate.

Medical and Biotech [MESH] Definitions

A highly fatal, acute hemorrhagic fever, clinically very similar to MARBURG VIRUS DISEASE, caused by EBOLAVIRUS, first occurring in the Sudan and adjacent northwestern (what was then) Zaire.

Vaccines or candidate vaccines used to prevent EBOLA HEMORRHAGIC FEVER.

A genus in the family FILOVIRIDAE consisting of several distinct species of Ebolavirus, each containing separate strains. These viruses cause outbreaks of a contagious, hemorrhagic disease (HEMORRHAGIC FEVER, EBOLA) in humans, usually with high mortality.

A group of viral diseases of diverse etiology but having many similar clinical characteristics; increased capillary permeability, leukopenia, and thrombocytopenia are common to all. Hemorrhagic fevers are characterized by sudden onset, fever, headache, generalized myalgia, backache, conjunctivitis, and severe prostration, followed by various hemorrhagic symptoms. Hemorrhagic fever with kidney involvement is HEMORRHAGIC FEVER WITH RENAL SYNDROME.

Sampling of blood levels of the adrenocorticotropic hormone (ACTH) by withdrawal of blood from the inferior petrosal sinus. The inferior petrosal sinus arises from the cavernous sinus and runs to the internal jugular vein. Sampling of blood at this level is a valuable tool in the differential diagnosis of Cushing disease, Cushing syndrome, and other adrenocortical diseases.

More From BioPortfolio on "Open Study of the Duration of Immunity After Vaccination With GamEvac"

Quick Search

Relevant Topics

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Searches Linking to this Trial