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Hemorrhagic Fever, EbolaPhase 2/3STRIVENCT02378753

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

A Phase 2/3 study testing rVSVΔG-ZEBOV in people with Hemorrhagic Fever, Ebola, run by Centers for Disease Control and Prevention at 5 sites in Sierra Leone.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hemorrhagic Fever, Ebola
What is being tested?
rVSVΔG-ZEBOV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,651 participants
Where
5 sitesSierra Leone
Study dates
Apr 2015to 5 Dec 2016
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sierra Leone5 sites

  • Bombali

    Bombali District

  • College of Medicine and Allied Health Sciences (COMAHS)

    Freetown, Western Area Urban

  • Port Loko

    Port Loko District

  • Tonkolili

    Tonkolili District

  • Western Area Rural

    Western Area District

Other trials in Sierra Leone

About this study

Official title: [rVSVΔG-ZEBOV] Ebola Prevention Vaccine Evaluation in Sierra Leone

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.

Read the detailed description

The Ebola outbreak was confirmed in March 2014 with widespread and intense transmission in Guinea, Liberia, and Sierra Leone. While there are no U.S. Food and Drug Administration (FDA)-approved pharmaceuticals to prevent or treat Ebola, two candidate vaccines are being tested in humans for dosing, tolerability, and safety. This study will evaluate monovalent recombinant vesicular stomatitis virus Ebola vaccine that remains replication competent (rVSVΔG-ZEBOV) in 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 unblinded, randomized trial will evaluate vaccine efficacy (VE) and safety 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. This includes: 1) personnel working in healthcare facilities where care is provided for Ebola patients; 2) personnel working in non-Ebola healthcare facilities who may have exposure to undiagnosed Ebola-infected individuals; and 3) personnel working in one of the following job categories: surveillance team, ambulance team, or laboratory worker responsible for swabbing deceased persons. Staff members involved in this study are also eligible to receive the vaccine under this protocol; study staff will be followed for 6 months post-vaccination to monitor for safety of rVSVΔG-ZEBOV.

Eligible participants within a healthcare facility or frontline team will be enrolled and individually randomized to either immediate or deferred vaccination. A single dose of rVSVΔG-ZEBOV will be administered intramuscularly. Immediate vaccination is defined as vaccination within 7 days of enrollment and deferred vaccination is defined as vaccination at the end of an 18-24 week follow-up period. Participants will not be blinded to the randomized assignment of immediate or deferred vaccination. All enrolled participants will have the opportunity to receive rVSVΔG-ZEBOV by the end of the study. Enrollment and vaccination will be phased over time.

Ebola events that occur during the 18-24 week post-enrollment will be included in the VE analysis, with the immediate vaccination arm contributing vaccinated follow-up time and the deferred vaccination arm contributing unvaccinated follow-up time. All participants, regardless of randomized assignment, will be followed for 6 months after vaccination to monitor for safety of rVSVΔG-ZEBOV.

Being tested
rVSVΔG-ZEBOV
Keywords
Ebola, Sierra Leone, vaccine, rVSVΔG-ZEBOV
Medical subject headings
Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rVSVΔG-ZEBOVBiological

    Also called BPSC-1001

    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).

Study groups in NCT02378753
Study groupRoleWhat they receive
rVSVΔG-ZEBOV (immediate vaccination)ExperimentalOne intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units)
Receives: Biological: rVSVΔG-ZEBOV
rVSVΔG-ZEBOV (deferred vaccination)ExperimentalOne 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).
Receives: Biological: rVSVΔG-ZEBOV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: > 21 days following vaccination

  2. 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.

    Measured: 6 months following vaccination

Secondary outcomes (5)

  1. Death Due to Laboratory-confirmed Ebola

    Deaths due to Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.

    Measured: 6 months following vaccination

  2. Ebola Confirmed by Non-study or Study Diagnostics

    Incidence of Ebola confirmed by the STRIVE study laboratory or by a non-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.

    Measured: 6 months following vaccination

  3. Suspected, Probable or Laboratory-confirmed Ebola

    Incidence of suspected, probable, or laboratory-confirmed Ebola, where "suspected" and "probable" cases are defined by the August 9, 2014 World Health Organization case definition recommendations for use during an Ebola outbreak, and laboratory-confirmed Ebola includes both study laboratory and non-study laboratory diagnostics. An Ebola Screening Form was required to be completed for all participants referred for evaluation of suspected Ebola; the Outcome Measure (Count of Participants) reflects the number of participants in each group for whom an Ebola Screening Form was completed.

    Measured: 6 months following vaccination

  4. 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.

    Solicited symptoms were assessed only in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 7 days after vaccination (immediate group) or after enrollment without vaccination (deferred group). Participants were actively solicited for the occurrence of local (injection-site) pain, redness, and swelling and the following systemic reactogenicity symptoms: fever, joint pain, joint swelling, muscle pain, fatigue, feeling unwell, chills, headache, vomiting, nausea, diarrhea, abdominal pain, rash, oral ulcers, and skin vesicles (blisters).

    Measured: Vaccination day and for 7 days following vaccination

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

    Solicited local and systemic reactogenicity symptoms and unsolicited adverse events were assessed in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 28 days after vaccination (immediate group) or after enrollment without vaccination (deferred group).

    Measured: During 28 days following vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion8 Nov 2016
  4. Study completion5 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8,651 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02378753
Sponsor's protocol ID
CDC-NCIRD-6689
Acronym
STRIVE
Status last verified
Jul 2016
First submitted
19 Feb 2015
Last updated
5 Apr 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes

Publications

  • 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.

    PubMed 36208978

  • 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.

    PubMed 32017677

  • 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.

    PubMed 29788349

  • 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.

    PubMed 29788348

  • 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.

    PubMed 29788347

  • 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.

    PubMed 29788346

  • 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.

    PubMed 29788345

  • 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.

    PubMed 29788343

  • 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.

    PubMed 29788342

  • 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.

    PubMed 29788341

  • 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.

    PubMed 29788340

  • 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.

    PubMed 29788339

  • 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.

    PubMed 28647166

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing rVSVΔG-ZEBOV in people with Hemorrhagic Fever, Ebola, run by Centers for Disease Control and Prevention at 5 sites in Sierra Leone.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Laboratory-confirmed Ebola (Study Diagnostics) (time frame: > 21 days following vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02378753, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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