Ebola Ebola
Conditions
Interventions
Immediate vaccination with rVSVdeltaG-ZEBOV (BPSC-1001)
Deferred vaccination with rVSVdeltaG-ZEBOV (BPSC-1001)
Sponsors
U.S. Centers for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older. 2.Member of target population at time of enrollment: -Active worker in an Ebola care, holding, or treatment center (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); -Active worker in a facility providing non-Ebola-related healthcare (may include physicians, nurses, nurse aides, lab technicians, pharmacists, pharmacy technicians, cleaners, and security and administrative staff); -Active frontline worker in one of the following job categories: surveillance team, ambulance team, burial worker or worker responsible for swabbing deceased persons) 3.Reasonably anticipates living in Sierra Leone for the 18-24 weeks following enrollment. 4.Reachable by phone throughout the 6 month post-vaccination safety follow-up period. 5.Willing to adhere to personal protective equipment (PPE) and infection control recommendations. 6.Able and willing to complete the informed consent process and study procedures. 7.Willing to receive vaccine in either the immediate or the deferred trial arms, according to random assignment.
Exclusion criteria
Exclusion criteria: 1.History of Ebola (self-report). 2.Prior receipt of experimental Ebola or Marburg vaccine. 3.History of human immunodeficiency virus (HIV) or clinically important immunodeficiency (self-report). 4.Any history of allergy or anaphylaxis to prior vaccines. 5.Breast-feeding an infant or child. 6.Any reason the investigator suspects that data collected from this person would be incomplete or of poor quality. 7.Current pregnancy (a negative urine pregnancy test is required for women participants younger than 50 years of age who self report as not pregnant). 8.Currently being followed for known exposure to Ebola. 9.Known experimental research agents or other vaccine within 28 days (4 weeks) before vaccination. 10.Fever greater than or equal to 38.0°C (greater than or equal to 100.4°F) at time of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of SAEs during the 6 months following vaccination;Laboratory-confirmed Ebola (study diagnostics) | — |
Secondary
| Measure | Time frame |
|---|---|
| Death due to laboratory-confirmed Ebola (study diagnostics);Ebola confirmed by non-study or study diagnostics;Suspected, probable, or laboratory-confirmed Ebola;Occurrence of solicited injection-site and systemic reactogenicity signs and symptoms, including fever, on vaccination day and during the 7 days following the vaccination;Occurrence of solicited and unsolicited AEs during the 28 days following the vaccination | — |
Countries
Sierra Leone
Contacts
Public ContactMunda Rogers
Public Relations Officer
Outcome results
None listed