Ebola Virus Disease Clinical Trial
Official title:
A Phase IB Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults in Kampala, Uganda
This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.
The Ebola and Marburg viruses are both filoviruses known to induce hemorrhagic fever—a set
of symptoms characterized by sudden onset, aching, fever, and bleeding in the internal
organs. Both filoviruses are associated with high mortality rates, and the Centers for
Disease Control (CDC) lists them as Category A bioterrorism agents because of their
potential for a major public health impact. Vaccines for both viruses are under development
using a prime-boost strategy that involves multiple injections over a period of time to
confer long-lasting immunity. Preliminary research supports the vaccines' safety. This study
will test these experimental vaccines for the Ebola and Marburg viruses, first administered
separately and then together, to ensure they are safe and do not have side effects.
Participation in this study will entail 11 study visits over 2 years. The study will have
two parts, to be completed sequentially, and three groups. In part one, participants will be
randomly assigned to the first group, which will receive the experimental Ebola DNA vaccine,
or the second group, which will receive the experimental Marburg DNA vaccine. In part two,
the third group will receive both the Ebola and the Marburg vaccines, one shot in each arm.
One fifth of the participants in each group will be controls and receive placebo injections.
All vaccines and placebos will be delivered via an intramuscular injection at three time
points: at study entry, after 4 weeks, and after 8 weeks.
Participants will complete study assessments at 12 points in time: at baseline and at Weeks
2, 4, 6, 8, 10, 12, 24, 32, 52, 78, and 104. At each assessment, changes in health and
medications will be recorded and blood will be drawn. Participants will also complete a
diary card daily for 5 days after receiving each injection. In it, they will record their
temperature and any skin changes at the injection site.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
| 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 | |
| Withdrawn |
NCT04268966 -
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
|
Phase 2 | |
| Completed |
NCT02267109 -
Phase 1 Trial of Ebola Vaccine in Mali
|
Phase 1 | |
| 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 |
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 | |
| 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 |