STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)

NCT02378753 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CDC-NCIRD-6689
• Study Type: interventional
• Target: 8,651
• Locations: 1 country
• Sites: 5

Brief Summary

The 2014 outbreak of Ebola in West Africa is the largest in recorded history with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. The high infectivity of blood and secretions, lack of appropriate personal protective equipment (PPE) and challenges in following infection control and prevention protocols put healthcare workers at high risk during outbreaks, and direct contact with the bodies of deceased Ebola victims can also sustain community transmission. This study will accelerate introduction and use of monovalent recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV) among healthcare workers and frontline personnel involved in the Ebola outbreak response in Sierra Leone, while concurrently evaluating the safety and efficacy of the vaccine. This is an unblinded, randomized trial with phased vaccine introduction in the target population. Participation in the study will be voluntary and open to adults 18 years of age and older who are at high risk of exposure to Ebola infection through their daily work and who work in a selected study area.

Conditions

Hemorrhagic Fever, Ebola

Keywords

Ebola; Sierra Leone; vaccine; rVSVΔG-ZEBOV

Outcome Measures

Primary Outcomes (2)

• Laboratory-confirmed Ebola (Study Diagnostics)

  Incidence of Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.

  > 21 days following vaccination

• Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination

  Number of Participants with Occurrence of SAEs within the 6-month follow-up period following a single dose of rVSVΔG-ZEBOV. Vaccination in the immediate group occurred within 7 days of enrollment if possible, and vaccination in the deferred-vaccination group occurred 18-24 weeks after enrollment.

  6 months following vaccination

Secondary Outcomes (5)

• Death Due to Laboratory-confirmed Ebola

  6 months following vaccination

• Ebola Confirmed by Non-study or Study Diagnostics

  6 months following vaccination

• Suspected, Probable or Laboratory-confirmed Ebola

  6 months following vaccination

• Number of Participants With Occurrence of Solicited Injection-site and Systemic Reactogenicity Signs and Symptoms, Including Fever, on Vaccination Day and During the 7 Days Following the Vaccination or Enrollment.

  Vaccination day and for 7 days following vaccination

• Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment

  During 28 days following vaccination

Study Arms (2)

rVSVΔG-ZEBOV (immediate vaccination)

EXPERIMENTAL

One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10\^7 plaque forming units)

Biological: rVSVΔG-ZEBOV

rVSVΔG-ZEBOV (deferred vaccination)

EXPERIMENTAL

One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10\^7 plaque forming units) in participants randomized to receive deferred vaccination (18-24 weeks after enrollment).

Biological: rVSVΔG-ZEBOV

Interventions

rVSVΔG-ZEBOV BIOLOGICAL

The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain).

Also known as: BPSC-1001

rVSVΔG-ZEBOV (deferred vaccination); rVSVΔG-ZEBOV (immediate vaccination)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Member of target population at the 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.
• Reasonably anticipates living in Sierra Leone for the 18-24 weeks following enrollment.
• Reachable by phone throughout the 6 month post-vaccination safety follow-up period.
• Willing to adhere to personal protective equipment (PPE) and infection control recommendations.
• Able and willing to complete the informed consent process and study procedures.
• Willing to receive vaccine in either the immediate or the deferred trial arms, according to random assignment.

You may not qualify if:

• History of Ebola (self-report).
• Prior receipt of experimental Ebola or Marburg vaccine.
• History of human immunodeficiency virus (HIV) or clinically important immunodeficiency (self-report).
• Any history of allergy or anaphylaxis to prior vaccines
• Breast-feeding an infant or child.
• Any reason the investigator suspects that data collected from this person would be incomplete or of poor quality.
• Current pregnancy (a negative urine pregnancy test is required for women participants \<50 years of age who self-report as not pregnant).
• Currently being followed for known exposure to Ebola.
• Known experimental research agents or other vaccine within 28 days (4 weeks) before vaccination.
• Fever ≥ 38.0°C (100.4°F) at time of vaccination.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• University of Sierra Leone: collaborator
• Ministry of Health and Sanitation, Sierra Leone: collaborator
• Department of Health and Human Services: collaborator
• eHealth Africa: collaborator

Study Sites (5)

College of Medicine and Allied Health Sciences (COMAHS)

Freetown, Western Area Urban, Sierra Leone

Location

Bombali

Bombali District, Sierra Leone

Location

Port Loko

Port Loko District, Sierra Leone

Location

Tonkolili

Tonkolili District, Sierra Leone

Location

Western Area Rural

Western Area District, Sierra Leone

Location

Related Publications (13)

• Simon JK, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller BG, Welebob C, Hanson ME, Grais RF. Immunogenicity of rVSVDeltaG-ZEBOV-GP Ebola vaccine (ERVEBO(R)) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials. Vaccine. 2022 Nov 2;40(46):6599-6606. doi: 10.1016/j.vaccine.2022.09.037. Epub 2022 Oct 5.

  PMID: 36208978 DERIVED

• Legardy-Williams JK, Carter RJ, Goldstein ST, Jarrett OD, Szefer E, Fombah AE, Tinker SC, Samai M, Mahon BE. Pregnancy Outcomes among Women Receiving rVSVDelta-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola. Emerg Infect Dis. 2020 Mar;26(3):541-548. doi: 10.3201/eid2603.191018. Epub 2020 Mar 17.

  PMID: 32017677 DERIVED

• Kabineh AK, Carr W, Motevalli M, Legardy-Williams J, Vincent W, Mahon BE, Samai M. Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience. J Infect Dis. 2018 May 18;217(suppl_1):S56-S59. doi: 10.1093/infdis/jiy111.

  PMID: 29788349 DERIVED

• Carter RJ, Senesi RGB, Dawson P, Gassama I, Kargbo SAS, Petrie CR, Rogers MH, Samai M, Luman ET. Participant Retention in a Randomized Clinical Trial in an Outbreak Setting: Lessons From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE). J Infect Dis. 2018 May 18;217(suppl_1):S65-S74. doi: 10.1093/infdis/jiy094.

  PMID: 29788348 DERIVED

• Conteh MA, Goldstein ST, Wurie HR, Gidudu J, Lisk DR, Carter RJ, Seward JF, Hampton LM, Wang D, Andersen LE, Arvay M, Schrag SJ, Dawson P, Fombah AE, Petrie CR, Feikin DR, Russell JBW, Lindblad R, Kargbo SAS, Samai M, Mahon BE. Clinical Surveillance and Evaluation of Suspected Ebola Cases in a Vaccine Trial During an Ebola Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola. J Infect Dis. 2018 May 18;217(suppl_1):S33-S39. doi: 10.1093/infdis/jiy061.

  PMID: 29788347 DERIVED

• Jarrett OD, Seward JF, Fombah AE, Lindblad R, Jalloh MI, El-Khorazaty J, Dawson P, Burton D, Zucker J, Carr W, Bah MM, Deen GF, George PM, James F, Lisk DR, Pratt D, Russell JBW, Sandy JD, Turay P, Hamel MJ, Schrag SJ, Walker RE, Samai M, Goldstein ST. Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola. J Infect Dis. 2018 May 18;217(suppl_1):S24-S32. doi: 10.1093/infdis/jiy042.

  PMID: 29788346 DERIVED

• Samai M, Seward JF, Goldstein ST, Mahon BE, Lisk DR, Widdowson MA, Jalloh MI, Schrag SJ, Idriss A, Carter RJ, Dawson P, Kargbo SAS, Leigh B, Bawoh M, Legardy-Williams J, Deen G, Carr W, Callis A, Lindblad R, Russell JBW, Petrie CR, Fombah AE, Kargbo B, McDonald W, Jarrett OD, Walker RE, Gargiullo P, Bash-Taqi D, Gibson L, Fofanah AB, Schuchat A; STRIVE Study Team. The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak. J Infect Dis. 2018 May 18;217(suppl_1):S6-S15. doi: 10.1093/infdis/jiy020.

  PMID: 29788345 DERIVED

• Carter RJ, Idriss A, Widdowson MA, Samai M, Schrag SJ, Legardy-Williams JK, Estivariz CF, Callis A, Carr W, Webber W, Fischer ME, Hadler S, Sahr F, Thompson M, Greby SM, Edem-Hotah J, Momoh RM, McDonald W, Gee JM, Kallon AF, Spencer-Walters D, Bresee JS, Cohn A, Hersey S, Gibson L, Schuchat A, Seward JF. Implementing a Multisite Clinical Trial in the Midst of an Ebola Outbreak: Lessons Learned From the Sierra Leone Trial to Introduce a Vaccine Against Ebola. J Infect Dis. 2018 May 18;217(suppl_1):S16-S23. doi: 10.1093/infdis/jix657.

  PMID: 29788343 DERIVED

• Fombah AE, Goldstein ST, Jarrett OD, Jalloh MI, El-Khorazaty J, Lisk DR, Legardy-Williams J, Pratt DA, George PM, Russell JBW, Schrag SJ, Dawson P, Deen GF, Carr W, Lindblad R, James F, Bah MM, Yillia JF, Sandy JD, Turay PE, Conteh MA, Slutsker L, Mahon BE, Samai M, Seward JF. Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE). J Infect Dis. 2018 May 18;217(suppl_1):S75-S80. doi: 10.1093/infdis/jix603.

  PMID: 29788342 DERIVED

• Callis A, Carter VM, Ramakrishnan A, Albert AP, Conteh L, Barrie AA, Fahnbulleh L, Koroma MM, Saidu S, Williams O, Samai M. Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE. J Infect Dis. 2018 May 18;217(suppl_1):S40-S47. doi: 10.1093/infdis/jix558.

  PMID: 29788341 DERIVED

• Edem-Hotah J, McDonald W, Abu PM, Luman ET, Carter RJ, Koker A, Goldstein ST. Utilizing Nurses to Staff an Ebola Vaccine Clinical Trial in Sierra Leone during the Ebola Outbreak. J Infect Dis. 2018 May 18;217(suppl_1):S60-S64. doi: 10.1093/infdis/jix389.

  PMID: 29788340 DERIVED

• Jusu MO, Glauser G, Seward JF, Bawoh M, Tempel J, Friend M, Littlefield D, Lahai M, Jalloh HM, Sesay AB, Caulker AF, Samai M, Thomas V, Farrell N, Widdowson MA. Rapid Establishment of a Cold Chain Capacity of -60 degrees C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone. J Infect Dis. 2018 May 18;217(suppl_1):S48-S55. doi: 10.1093/infdis/jix336.

  PMID: 29788339 DERIVED

• Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.

  PMID: 28647166 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Results Point of Contact

• Title: Dr. Barbara Mahon
• Organization: Centers for Disease Control and Prevention

bdm3@cdc.gov

404-718-1157

Study Officials

• Mohamed Samai, MBChB,PhD

  University of Sierra Leone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 4, 2015
• Study Start: April 1, 2015
• Primary Completion: November 8, 2016
• Study Completion: December 5, 2016
• Last Updated: April 5, 2018
• Results First Posted: April 5, 2018

Record last verified: 2016-07

Locations

SI (5)