STRIVE: Sierra Leone Trial to Introduce a Vaccine against Ebola

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201502001037220
• Date of registration: 16/02/2015
• Prospective Registration: Yes
• Primary sponsor: U.S. Centers for Disease Control and Prevention
• Public title: STRIVE: Sierra Leone Trial to Introduce a Vaccine against Ebola
• Scientific title: [rVSV¿G-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone
• Date of first enrolment: 07/03/2015
• Target sample size: 6000
• Recruitment status: Other
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1037
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Sequence of potential assignments to either immediate vaccination or deferred vaccination arm will be generated.,Random vaccination assignments will be generated by statistician and concealed from study staff. Assignments will be disclosed to participants following enrollment.
• Phase: Not Applicable

Countries of recruitment

Sierra Leone

Contacts

• Name: Munda Rogers
• Affiliation: Public Relations Officer

• Name: Durodamil Radcliffe Lisk
• Affiliation: Professor

Key inclusion & exclusion 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: 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.

Age minimum: 18 Year(s)
Age maximum: 100 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola
Ebola

Ebola

Intervention(s)

Deferred vaccination with rVSVdeltaG-ZEBOV (BPSC-1001)

Immediate vaccination with rVSVdeltaG-ZEBOV (BPSC-1001)

Primary Outcome(s)

Occurrence of SAEs during the 6 months following vaccination

Laboratory-confirmed Ebola (study diagnostics)

Secondary Outcome(s)

Ebola confirmed by non-study or study diagnostics

Occurrence of solicited injection-site and systemic reactogenicity signs and symptoms, including fever, on vaccination day and during the 7 days following the vaccination

Death due to laboratory-confirmed Ebola (study diagnostics)

Suspected, probable, or laboratory-confirmed Ebola

Occurrence of solicited and unsolicited AEs during the 28 days following the vaccination

Secondary ID(s)

CDC IRB #6689

Source(s) of Monetary Support

U.S. Centers for Disease Control and Prevention (CDC)

Ethics review

Status: Approved
Approval date:
Contact:

U.S. Centers for Disease Control and Prevention Human Research Protection Office

Status: Approved
Approval date: 03/02/2015
Contact:

Sierra Leone Ethics and Scientific Review Committee