Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 1500
• Participant gender: Both

Summary

Background:

• Ebola virus disease (EVD) affects many people in Liberia and other countries in West Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause Ebola.

Objectives:

• To study the safety and efficacy of two Ebola vaccines.

Eligibility:

• Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never had Ebola.

Design:

• Participants will give information including birthdate, gender, occupation, and location of home. They will give contact information for themselves and 2 alternate contacts. They will give a history of their contact with people with Ebola. Some participants may have a physical. They may have blood taken.

• Participants will be injected with either an Ebola vaccine or a placebo with a needle in the upper arm. The placebo is a salt solution.

• Participants will have blood taken.

• Participants will be watched for 30 minutes.

• Participants will return to the clinic 1 week and 1 month after they get the shot. They will have blood taken.

• After that, participants will be contacted monthly to discuss how they are feeling. They may be contacted by phone, may visit the clinic, or may have a home visit.

• The study ends 8-12 months after participants get the shot. If one of the vaccines works against Ebola and does not have many side effects, participants can get the vaccine if they did not get it in the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines
• Last Updated: 2016-12-06

Criteria

• INCLUSION CRITERIA:

The inclusion criteria for the study are broad reflecting the target population that would eventually receive an efficacious vaccine.

• Informed consent

• Age greater than or equal to 18 years

• Likely to be in the surrounding area of the vaccination center for at least one year.

EXCLUSION CRITERIA:

• Fever greater than or equal to 38.0 degrees Celsius

• History of EVD (self-report)

• Current pregnancy (a negative urine pregnancy test is required for women of child-bearing potential)

• Breast-feeding an infant

• Any condition which would limit the ability of the participant to meet the requirements of the study protocol