A Phase 2/3 interventional study of rVSVΔG-ZEBOV in Hemorrhagic Fever, Ebola, sponsored by Centers for Disease Control and Prevention. Completed at 5 sites in Sierra Leone. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by Centers for Disease Control and Prevention · Phase 2/3, Interventional, and Prevention
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.
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.
102 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 8,651 is above the median of 91 across 79 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Member of target population at the time of enrollment:
Exclusion Criteria:
One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10\^7 plaque forming units)
Biological: rVSVΔG-ZEBOV
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
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
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.
Time frame: > 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.
Time frame: 6 months following vaccination
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.
Time frame: 6 months following vaccination
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.
Time frame: 6 months following vaccination
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.
Time frame: 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.
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).
Time frame: 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
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).
Time frame: During 28 days following vaccination
| Milestone | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Started | 4319 | 4332 |
| Completed | 4101 | 3637 |
| Not completed | 218 | 695 |
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.
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Laboratory-confirmed Ebola (Study Diagnostics) | 0 | 0 |
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.
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination | 54 | 47 |
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.
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Death Due to Laboratory-confirmed Ebola | 0 | 0 |
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.
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Ebola Confirmed by Non-study or Study Diagnostics | 0 | 0 |
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.
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Suspected, Probable or Laboratory-confirmed Ebola | 27 | 17 |
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).
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred 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. | 202 | 76 |
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).
| Participants | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| Solicited AEs | 203 | 117 |
| Unsolicited AEs | 101 | 27 |
Collected over 6 months after vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rVSVΔG-ZEBOV (Immediate Vaccination) | 8/4,261 (0.2%) | 54/4,261 (1.3%) | 2,537/4,261 (59.5%) |
| rVSVΔG-ZEBOV (Deferred Vaccination) | 11/3,788 (0.3%) | 47/3,788 (1.2%) | 1,512/3,788 (39.9%) |
| Event | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| MalariaInfections and infestations | 12/4261 | 3/3788 |
| Inguinal herniaGastrointestinal disorders | 3/4261 | 4/3788 |
| Peptic ulcerGastrointestinal disorders | 3/4261 | 3/3788 |
| GastroenteritisInfections and infestations | 0/4261 | 3/3788 |
| CellulitisInfections and infestations | 1/4261 | 2/3788 |
| Pelvic inflammatory diseaseInfections and infestations | 1/4261 | 2/3788 |
| Typhoid feverInfections and infestations | 1/4261 | 2/3788 |
| Cerebrovascular accidentNervous system disorders | 0/4261 | 2/3788 |
| Sickle cell anaemia with crisisBlood and lymphatic system disorders | 2/4261 | 0/3788 |
| Inguinal hernia, obstructiveGastrointestinal disorders | 2/4261 | 1/3788 |
| Event | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) |
|---|---|---|
| HeadacheNervous system disorders | 1402/4261 | 770/3788 |
| PainGeneral disorders | 663/4261 | 370/3788 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 530/4261 | 370/3788 |
| PyrexiaGeneral disorders | 467/4261 | 222/3788 |
| Feeling hotGeneral disorders | 403/4261 | 281/3788 |
| AstheniaGeneral disorders | 361/4261 | 242/3788 |
| Decreased appetiteMetabolism and nutrition disorders | 354/4261 | 195/3788 |
| RashGastrointestinal disorders | 274/4261 | 155/3788 |
| PruritusSkin and subcutaneous tissue disorders | 256/4261 | 138/3788 |
| Abdominal painGastrointestinal disorders | 240/4261 | 200/3788 |
Baseline characteristics were re-assessed for participants on the deferred arm when they presented for vaccination (18-24 weeks after randomization/enrollment). The number on the deferred arm reflects the number of deferred participants who returned for vaccination (e.g. did not drop out during the 18-24 week period).
| Age, Continuous(years) | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) | Total |
|---|---|---|---|
| Median | 30.5 (18.1 to 78.0) | 31.0 (18.0 to 79.5) | 30.7 (18.0 to 79.5) |
| Sex: Female, Male(Participants) | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) | Total |
|---|---|---|---|
| Female | 1703 | 1704 | 3407 |
| Male | 2616 | 2628 | 5244 |
| Region of Enrollment(Participants) | rVSVΔG-ZEBOV (Immediate Vaccination) | rVSVΔG-ZEBOV (Deferred Vaccination) | Total |
|---|---|---|---|
| Sierra Leone | 4183 | 3821 | 8004 |
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