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

• ClinicalTrials.gov Identifier: NCT02378753
• Recruitment Status: Completed
• First Posted: March 4, 2015
• Results First Posted: April 5, 2018
• Last Update Posted: April 5, 2018
• Sponsor: Centers for Disease Control and Prevention
• Collaborators: University of Sierra Leone; Ministry of Health and Sanitation, Sierra Leone; Department of Health and Human Services; eHealth Africa
• Information provided by (Responsible Party): Centers for Disease Control and Prevention

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Hemorrhagic Fever, Ebola
• Intervention: Biological: rVSVΔG-ZEBOV
• Enrollment: 8651

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Period Title: Overall Study
Started	4319	4332
Completed	4101	3637
Not Completed	218	695

Baseline Characteristics

Arm/Group Title		rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)	Total
Arm/Group Description		One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).	Total of all reporting groups
Overall Number of Baseline Participants		4319	4332	8651
Baseline Analysis Population Description		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; Median (Full Range); Unit of measure: Years
	Number Analyzed	4319 participants	4332 participants	8651 participants
		30.5; (18.1 to 78.0)	31.0; (18.0 to 79.5)	30.7; (18.0 to 79.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	4319 participants	4332 participants	8651 participants
	Female	1703 39.4%	1704 39.3%	3407 39.4%
	Male	2616 60.6%	2628 60.7%	5244 60.6%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Sierra Leone	Number Analyzed	4319 participants	4332 participants	8651 participants
		4183 96.9%	3821 88.2%	8004 92.5%

Outcome Measures

1. Primary Outcome

Title	Laboratory-confirmed Ebola (Study Diagnostics)
Description	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

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples to the study laboratory for testing.

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	24	10
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed for this endpoint is the number of participants in each group who provided any safety/AE data during 6-month (18- to 24-week) follow-up.

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	4261	3788
Measure Type: Count of Participants; Unit of Measure: Participants
	54 1.3%	47 1.2%

3. Secondary Outcome

Title	Death Due to Laboratory-confirmed Ebola
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	4261	3788
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

4. Secondary Outcome

Title	Ebola Confirmed by Non-study or Study Diagnostics
Description	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

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples for testing, whether to the study laboratory or to a non-study laboratory.

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	52	31
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

5. Secondary Outcome

Title	Suspected, Probable or Laboratory-confirmed Ebola
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	4261	3788
Measure Type: Count of Participants; Unit of Measure: Participants
	27 0.6%	17 0.4%

6. Secondary Outcome

Title	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.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	217	219
Measure Type: Count of Participants; Unit of Measure: Participants
	202 93.1%	76 34.7%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description:	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
Overall Number of Participants Analyzed	217	219
Measure Type: Count of Participants; Unit of Measure: Participants
Solicited AEs	203 93.5%	117 53.4%
Unsolicited AEs	101 46.5%	27 12.3%

Adverse Events

Time Frame	6 months after vaccination
Adverse Event Reporting Description	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. The overall number of participants analyzed is the number of participants in each group who provided any safety/AE data during 6-month (18- to 24-week) follow-up.
Arm/Group Title	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
Arm/Group Description	One intramuscular (deltoid) injection of rVSVΔG-ZEBOV (2 x 10^7 plaque forming units) 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).	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). 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).
All-Cause Mortality
	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/4261 (0.19%)	11/3788 (0.29%)
Serious Adverse Events
	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	54/4261 (1.27%)	47/3788 (1.24%)
Blood and lymphatic system disorders
Anaemia †	1/4261 (0.02%)	0/3788 (0.00%)
Sickle cell anaemia with crisis †	2/4261 (0.05%)	0/3788 (0.00%)
Cardiac disorders
Myocardial infarction †	0/4261 (0.00%)	1/3788 (0.03%)
Eye disorders
Glaucoma †	0/4261 (0.00%)	1/3788 (0.03%)
Gastrointestinal disorders
Abdominal mass †	1/4261 (0.02%)	0/3788 (0.00%)
Acute abdomen †	1/4261 (0.02%)	0/3788 (0.00%)
Anal fistula †	0/4261 (0.00%)	1/3788 (0.03%)
Enteritis †	0/4261 (0.00%)	1/3788 (0.03%)
Gastric ulcer haemorrhage †	1/4261 (0.02%)	0/3788 (0.00%)
Inguinal hernia †	3/4261 (0.07%)	4/3788 (0.11%)
Inguinal hernia, obstructive †	2/4261 (0.05%)	1/3788 (0.03%)
Pancreatitis †	1/4261 (0.02%)	0/3788 (0.00%)
Peptic ulcer †	3/4261 (0.07%)	3/3788 (0.08%)
Toothache †	1/4261 (0.02%)	0/3788 (0.00%)
Umbilical hernia †	1/4261 (0.02%)	0/3788 (0.00%)
General disorders
Death †	0/4261 (0.00%)	1/3788 (0.03%)
Drowning †	0/4261 (0.00%)	1/3788 (0.03%)
Electrocution †	1/4261 (0.02%)	0/3788 (0.00%)
Hernia †	1/4261 (0.02%)	0/3788 (0.00%)
Hepatobiliary disorders
Hepatic cirrhosis †	0/4261 (0.00%)	1/3788 (0.03%)
Infections and infestations
Abscess limb †	1/4261 (0.02%)	0/3788 (0.00%)
Appendicitis †	2/4261 (0.05%)	1/3788 (0.03%)
Cellulitis †	1/4261 (0.02%)	2/3788 (0.05%)
Encephalitis †	1/4261 (0.02%)	0/3788 (0.00%)
Gastroenteritis †	0/4261 (0.00%)	3/3788 (0.08%)
HIV wasting syndrome †	1/4261 (0.02%)	0/3788 (0.00%)
Ludwig angina †	1/4261 (0.02%)	1/3788 (0.03%)
Malaria †	12/4261 (0.28%)	3/3788 (0.08%)
Pelvic inflammatory disease †	1/4261 (0.02%)	2/3788 (0.05%)
Pyonephrosis †	0/4261 (0.00%)	1/3788 (0.03%)
Salpingo-oophoritis †	0/4261 (0.00%)	1/3788 (0.03%)
Tooth abscess †	0/4261 (0.00%)	1/3788 (0.03%)
Typhoid fever †	1/4261 (0.02%)	2/3788 (0.05%)
Urinary tract infection †	1/4261 (0.02%)	1/3788 (0.03%)
Injury, poisoning and procedural complications
Ankle fracture †	1/4261 (0.02%)	0/3788 (0.00%)
Contusion †	1/4261 (0.02%)	0/3788 (0.00%)
Forearm fracture †	0/4261 (0.00%)	1/3788 (0.03%)
Incisional hernia †	0/4261 (0.00%)	1/3788 (0.03%)
Jaw fracture †	0/4261 (0.00%)	1/3788 (0.03%)
Lower limb fracture †	1/4261 (0.02%)	1/3788 (0.03%)
Skeletal injury †	0/4261 (0.00%)	1/3788 (0.03%)
Spinal cord injury †	0/4261 (0.00%)	1/3788 (0.03%)
Metabolism and nutrition disorders
Diabetes mellitus †	1/4261 (0.02%)	0/3788 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer †	0/4261 (0.00%)	1/3788 (0.03%)
Uterine cancer †	1/4261 (0.02%)	0/3788 (0.00%)
Uterine leiomyoma †	2/4261 (0.05%)	1/3788 (0.03%)
Nervous system disorders
Aphasia †	1/4261 (0.02%)	0/3788 (0.00%)
Cerebrovascular accident †	0/4261 (0.00%)	2/3788 (0.05%)
Haemorrhagic stroke †	0/4261 (0.00%)	1/3788 (0.03%)
Loss of consciousness †	1/4261 (0.02%)	0/3788 (0.00%)
Subarachnoid haemorrhage †	1/4261 (0.02%)	0/3788 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion complete †	1/4261 (0.02%)	0/3788 (0.00%)
Psychiatric disorders
Anxiety †	1/4261 (0.02%)	0/3788 (0.00%)
Conversion disorder †	0/4261 (0.00%)	1/3788 (0.03%)
Renal and urinary disorders
Ureterolithiasis †	0/4261 (0.00%)	1/3788 (0.03%)
Reproductive system and breast disorders
Adnexal torsion †	1/4261 (0.02%)	0/3788 (0.00%)
Breast mass †	1/4261 (0.02%)	0/3788 (0.00%)
Dysfunctional uterine bleeding †	0/4261 (0.00%)	1/3788 (0.03%)
Pelvic adhesions †	0/4261 (0.00%)	1/3788 (0.03%)
Respiratory, thoracic and mediastinal disorders
Asthma †	1/4261 (0.02%)	0/3788 (0.00%)
Interstitial lung disease †	0/4261 (0.00%)	1/3788 (0.03%)
Vascular disorders
Haematoma †	1/4261 (0.02%)	0/3788 (0.00%)
Hypertension †	1/4261 (0.02%)	0/3788 (0.00%)
Hypertensive crisis †	0/4261 (0.00%)	1/3788 (0.03%)
Hypovolaemic shock †	1/4261 (0.02%)	0/3788 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	rVSVΔG-ZEBOV (Immediate Vaccination)	rVSVΔG-ZEBOV (Deferred Vaccination)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2537/4261 (59.54%)	1512/3788 (39.92%)
Gastrointestinal disorders
Abdominal pain †	240/4261 (5.63%)	200/3788 (5.28%)
Rash †	274/4261 (6.43%)	155/3788 (4.09%)
General disorders
Asthenia †	361/4261 (8.47%)	242/3788 (6.39%)
Fatigue †	238/4261 (5.59%)	52/3788 (1.37%)
Feeling hot †	403/4261 (9.46%)	281/3788 (7.42%)
Pain †	663/4261 (15.56%)	370/3788 (9.77%)
Pyrexia †	467/4261 (10.96%)	222/3788 (5.86%)
Infections and infestations
Nasopharyngitis †	232/4261 (5.44%)	110/3788 (2.90%)
Metabolism and nutrition disorders
Decreased appetite †	354/4261 (8.31%)	195/3788 (5.15%)
Musculoskeletal and connective tissue disorders
Arthralgia †	530/4261 (12.44%)	370/3788 (9.77%)
Nervous system disorders
Headache †	1402/4261 (32.90%)	770/3788 (20.33%)
Skin and subcutaneous tissue disorders
Pruritus †	256/4261 (6.01%)	138/3788 (3.64%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Barbara Mahon
• Organization: Centers for Disease Control and Prevention
• Phone: 404-718-1157
• EMail: bdm3@cdc.gov

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Legardy-Williams JK, Carter RJ, Goldstein ST, Jarrett OD, Szefer E, Fombah AE, Tinker SC, Samai M, Mahon BE. Pregnancy Outcomes among Women Receiving rVSVΔ-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.

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.

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.

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.

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.

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. Erratum in: J Infect Dis. 2018 Jul 2;218(3):508-507.

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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.

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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°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.

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.

• Responsible Party: Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT02378753
• Other Study ID Numbers: CDC-NCIRD-6689
• First Submitted: February 19, 2015
• First Posted: March 4, 2015
• Results First Submitted: September 22, 2017
• Results First Posted: April 5, 2018
• Last Update Posted: April 5, 2018