Ebola Virus Disease Clinical Trial
Official title:
Phase 1b Trial to Evaluate Safety, Tolerability and Immune Responses of 2 Monovalent Chimpanzee Adenoviral Vectored Filovirus (Ebola-S and Marburg) Vaccines to Healthy Adults, Collection of Plasma/Serum for the Purposes of Assay Development
Primary Objective: • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10^11 particle units (PU) to healthy adults. Secondary Objectives: - To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg) (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked immunosorbent assay) ELISA - To collect sufficient post-vaccination plasma to support further development of filovirus assays
Primary Endpoints: Safety Assessment of product safety will include clinical observation and monitoring of clinical chemistry and hematology parameters. Safety will be closely monitored after injection and evaluated through Day 99 and one additional safety follow-up telephone call on Day 181 (± 14 Days). The following parameters will be assessed: - Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following the vaccination - Occurrence and severity of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination - Change from baseline for safety laboratory measures - Occurrence of adverse events of all severities through 28 days after vaccination - Occurrence of serious adverse events and new chronic medical conditions through the last safety follow up call at Day 181(± 14 days) Secondary Endpoints : - Antibody levels against vaccines cAd3-EBO-S and cAd3 Marburg as measured by enzyme-linked immunosorbent assay (ELISA) on Day 1, 15, 22, 29, 36, 43, 50, 57 and 64 - 20 Liters of plasma per vaccine group will be collected for the purpose of assay development ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00374309 -
Experimental Vaccine for Prevention of Ebola Virus Infection
|
Phase 1 | |
| Completed |
NCT03098862 -
PREVAIL VI: Identification of Host Genetic Factors Underlying Ebola Virus Disease Risk, Mortality, Long-term Sequelae, Viral RNA Persistence, Humoral Immunity, and Ebola Vaccine Response
|
||
| Completed |
NCT02509494 -
Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo
|
Phase 3 | |
| Recruiting |
NCT06093646 -
Addressing Medium- to Long-term EBOLA Associated Psychological Distress and Psychosocial Problems in Central Uganda
|
N/A | |
| Completed |
NCT02495246 -
A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
|
Phase 1 | |
| Completed |
NCT04906629 -
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees
|
Phase 1 | |
| Completed |
NCT05064956 -
Ad26.ZEBOV Booster in HIV+ Adults Previously Vaccinated With Ad26.ZEBOV/MVA-BN-Filo (EBOVAC HIV+ Booster Study)
|
Phase 2 | |
| Not yet recruiting |
NCT06126822 -
Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination With the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC
|
Phase 3 | |
| Completed |
NCT02267109 -
Phase 1 Trial of Ebola Vaccine in Mali
|
Phase 1 | |
| Withdrawn |
NCT04268966 -
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
|
Phase 2 | |
| Not yet recruiting |
NCT04822376 -
Prophylaxis Vaccine Antibodies Ebola
|
Phase 2 | |
| Recruiting |
NCT02333578 -
Clinical Trial to Evaluate the Efficacy and Safety of Convalescent Plasma for Ebola Treatment
|
N/A | |
| Completed |
NCT02662855 -
Efficacy of Favipiravir Against Severe Ebola Virus Disease
|
Phase 2 | |
| Active, not recruiting |
NCT04152486 -
Effectiveness and Safety of a Heterologous, Two-dose Ebola Vaccine in the DRC
|
Phase 3 | |
| Terminated |
NCT04250168 -
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
|
||
| Completed |
NCT03161366 -
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
|
Phase 3 | |
| Completed |
NCT03140774 -
Persistence of the Immune Response After Immunisation With Ebola Virus Vaccines
|
||
| Suspended |
NCT03462004 -
Evaluating the Live-Attenuated Human Parainfluenza Virus Type 3 Vectored Vaccine Candidate Expressing Ebolavirus Zaire Glycoprotein as the Sole Envelope Glycoprotein
|
Phase 1 | |
| Active, not recruiting |
NCT02876328 -
Partnership for Research on Ebola VACcinations
|
Phase 2 | |
| Not yet recruiting |
NCT05202288 -
Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers
|
Phase 2 |