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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination)
Hide 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
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination) Total
Hide 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
Hide 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%
1.Primary Outcome
Title Laboratory-confirmed Ebola (Study Diagnostics)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination)
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title rVSVΔG-ZEBOV (Immediate Vaccination) rVSVΔG-ZEBOV (Deferred Vaccination)
Hide 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%
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)
Hide 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%) 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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