An Open-Label, Case-Control Study to Compare the Anamnestic Response to the Recombinant Vesicular Stomatitis Delta Glycoprotein Zaire Ebola Virus (ZEBOV) Glycoprotein (rVSVDG-ZEBOV-GP) Ebola Virus Vaccine Among Ebola Virus Disease Survivors to the Primary Immune Response Among Naïve Age and Sex-Matched Controls

2023-970

This study is a vaccine-related clinical trial which will be conducted by our study team at Kenema Government Hospital (KGH)'s Viral Hemorrhagic Fever Program in collaboration with Tulane University School of Medicine. This study is funded by Merck \& Co., the developers of ERVEBO®. This investigational medicinal product (IMP) was successful in Sierra Leone through the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) working with the College of Medical and Allied Health Services (COMAHS) at the University of Sierra Leone. ERVEBO® was also successfully tested in Liberia and the Republic of Guinea. These successful trials led to the United States Food and Drug Administration (USFDA) approval of ERVEBO®, as well as approval for therapeutic use in the Democratic Republic of the Congo, Burundi, Ghana, and Zambia. This particular vaccination study will focus on the anamnestic response to the ERVEBO® vaccine, (full name - rVSVDG-ZEBOV-GP Ebola Virus Vaccine). The original clinical trials conducted excluded Ebola Virus Disease (EVD) survivors from participating. However, with ongoing research, there is evidence of waning immune response and even recurrent infections in EVD survivors.

2024-08-15

2025-03-01

2025-03-01

Not yet recruiting

Early phase I

40

Inclusion Criteria: * EVD survivors * History of admission and discharge from an Ebola Treatment Unit as registered by the Sierra Leone Association of Ebola Survivors (SLAES). * Anti-EBOV GP IgG positive by ELISA at the time of screening. * ≥18 years of age. * \>45.5 kg (100lbs). * Willingness to provide informed, written consent. * Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination and multiple blood collections over a period of six months. * Age- and sex-matched controls * Anti-EBOV GP IgG negative by ELISA at the time of screening. * ≥18 years of age. * Willingness to provide informed consent. * Willingness to undergo all study procedures including rVSVDG-ZEBOV-GP vaccination and multiple blood collections over a period of six months. Exclusion Criteria: * Have received the rVSVDG-ZEBOV-GP vaccine. * Currently participating in another clinical trial involving a vaccine. * Received a live vaccine within four weeks of screening. * \<18 years of age. * Weight \<45.5kg (or 100 lbs). * Refusal to provide informed, written consent. * Prisoners of other institutionalized individuals. * Research study staff and their immediate family members. * Inability to participate in research activities. * Pregnant and lactating females. * Known immunocompromised status. * Known allergy to vaccine components.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 survivor to control', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-05-30