Vaccine Info

rVSVN4CT1-EBOVGP1 Ebola Vaccine

Ebola Zaire Vaccine Description

rVSVN4CT1-EBOVGP1 is a Monovalent Ebola Zaire Vaccine candidate.  The vaccine consists of a highly attenuated recombinant vesicular stomatitis virus (rVSV) expressing Ebola virus glycoprotein (EBOV-GP).

Ebola Zaire Vaccine Indication

rVSVN4CT1-EBOVGP1 is an Ebola Zaire vaccine candidate indicated to prevent disease from the Ebola Virus.

The Ebola virus is transmitted to people from wild animals, such as fruit bats, porcupines, and non-human primates, and then spreads in the human population through direct contact with the blood, secretions, organs or other bodily fluids of infected people, and with surfaces and materials contaminated with these fluids.

Ebola Zaire Vaccine Dosage

This vaccine candidate is administered as an intramuscular injection.

The dosage is being tested in clinical trials.

Ebola Zaire Vaccine Clinical Trial

Clinical Trial NCT02718469: Trial to Evaluate Safety and Immunogenicity of an Ebola Zaire Vaccine in Healthy Adults

  • This Phase 1 study targets the enrollment of 39 healthy adults.
  • These participants are divided into 3 groups that will be administered one of three dose levels of the vaccine (low, medium, high).
  • The study participants will receive two doses of the vaccine: one on day 1 and the second on day 28 (1 month).
  • Three participants at each dose level will act as controls and receive a placebo instead of the active vaccine.
  • A total of 13 visits to the clinic are required over a period of 26 weeks. The total study is expected to take 9 months.

Adverse Events

No severe adverse events were observed.

Local adverse events occurred in ten (26%) of 39 participants after the first dose and nine (24%) of 38 participants after the second dose; the events lasted 3 days or less, were predominantly injection site tenderness (17 events) and injection site pain (ten events), and were either mild (19 events) or moderate (ten events) in intensity.

Systemic adverse events occurred in 13 (33%) of 39 participants after the first dose and eight (21%) of 38 participants after the second dose; the events were mild (45 events) or moderate (11 events) in severity, and the most common events were malaise or fatigue (13 events) and headache (12 events).

Results

rVSVN4CT1-EBOVGP1  Ebola Zaire vaccine candidate was well tolerated at all dose levels tested and was immunogenic despite a high degree of attenuation.

Further clinical trials are supported by these results.

Updated
01/17/2020 - 15:50