NCT00374309

Experimental Vaccine for Prevention of Ebola Virus Infection

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing VRC-EBOADV018-00-VP in Ebola Hemorrhagic Fever in 48 participants. Completed in 5 May 2009.

Timeline

5 September 2006

5 May 2009

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	48
Start date	5 September 2006
Estimated completion	5 May 2009
Sites	1 location across United States

Drugs / interventions tested

• VRC-EBOADV018-00-VP — full drug profile →

Conditions studied

• Ebola Hemorrhagic Fever — all drugs for Ebola Hemorrhagic Fever →
• Ebola Virus Disease — all drugs for Ebola Virus Disease →
• Ebola Virus Vaccines — all drugs for Ebola Virus Vaccines →
• Envelope Glycoprotein, Ebola Virus — all drugs for Envelope Glycoprotein, Ebola Virus →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Ebola Hemorrhagic Fever or Ebola Virus Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus.

Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment.

Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel, and they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed.

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Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New Vaccine Technologies to Combat Outbreak Situations.
   Rauch S, Jasny E, Schmidt KE, Petsch B. · · 2018 · cited 380× · PMID 30283434 · DOI 10.3389/fimmu.2018.01963
2. Enhanced protection against Ebola virus mediated by an improved adenovirus-based vaccine.
   Richardson JS, Yao MK, Tran KN, Croyle MA, et al · · 2009 · cited 61× · PMID 19390586 · DOI 10.1371/journal.pone.0005308
3. Airway delivery of an adenovirus-based Ebola virus vaccine bypasses existing immunity to homologous adenovirus in nonhuman primates.
   Richardson JS, Pillet S, Bello AJ, Kobinger GP. · · 2013 · cited 60× · PMID 23302894 · DOI 10.1128/jvi.02864-12
4. Antibodies for biodefense.
   Froude JW, Stiles B, Pelat T, Thullier P. · · 2011 · cited 46× · PMID 22123065 · DOI 10.4161/mabs.3.6.17621
5. Ebola: Lessons on Vaccine Development.
   Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
6. Ebola vaccines in clinical trial: The promising candidates.
   Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
7. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
   Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
8. Ebola Virus Infection: Overview and Update on Prevention and Treatment.
   Martínez MJ, Salim AM, Hurtado JC, Kilgore PE. · · 2015 · cited 23× · PMID 26363787 · DOI 10.1007/s40121-015-0079-5