Trial Outcomes & Findings for STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola) (NCT NCT02378753)

Last Updated: 2018-04-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

8651 participants

Primary outcome timeframe

> 21 days following vaccination

Results posted on

2018-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) 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).	rVSVΔG-ZEBOV (Deferred Vaccination) 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 Study STARTED	4319	4332
Overall Study COMPLETED	4101	3637
Overall Study NOT COMPLETED	218	695

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=4319 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=4332 Participants 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 n=8651 Participants Total of all reporting groups
Age, Continuous	30.5 years n=93 Participants	31.0 years n=4 Participants	30.7 years n=27 Participants
Sex: Female, Male Female	1703 Participants n=93 Participants	1704 Participants n=4 Participants	3407 Participants n=27 Participants
Sex: Female, Male Male	2616 Participants n=93 Participants	2628 Participants n=4 Participants	5244 Participants n=27 Participants
Region of Enrollment Sierra Leone	4183 Participants n=93 Participants	3821 Participants n=4 Participants	8004 Participants n=27 Participants

PRIMARY outcome

Timeframe: > 21 days following vaccination

Population: 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.

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=24 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=10 Participants 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).
Laboratory-confirmed Ebola (Study Diagnostics)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months following vaccination

Population: 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.

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.

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=4261 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=3788 Participants 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).
Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination	54 Participants	47 Participants

SECONDARY outcome

Timeframe: 6 months following vaccination

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.

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=4261 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=3788 Participants 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).
Death Due to Laboratory-confirmed Ebola	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months following vaccination

Population: 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.

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.

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=52 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=31 Participants 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).
Ebola Confirmed by Non-study or Study Diagnostics	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months following vaccination

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.

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=4261 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=3788 Participants 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).
Suspected, Probable or Laboratory-confirmed Ebola	27 Participants	17 Participants

SECONDARY outcome

Timeframe: Vaccination day and for 7 days following vaccination

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).

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=217 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=219 Participants 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).
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 Participants	76 Participants

SECONDARY outcome

Timeframe: During 28 days following vaccination

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).

Outcome measures

Outcome measures
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=217 Participants 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=219 Participants 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).
Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment Solicited AEs	203 Participants	117 Participants
Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment Unsolicited AEs	101 Participants	27 Participants

Adverse Events

rVSVΔG-ZEBOV (Immediate Vaccination)

Serious events: 54 serious events

Other events: 2537 other events

Deaths: 8 deaths

rVSVΔG-ZEBOV (Deferred Vaccination)

Serious events: 47 serious events

Other events: 1512 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	rVSVΔG-ZEBOV (Immediate Vaccination) n=4261 participants at risk 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).	rVSVΔG-ZEBOV (Deferred Vaccination) n=3788 participants at risk 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).
Gastrointestinal disorders Abdominal pain	5.6% 240/4261 • 6 months after 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. 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.	5.3% 200/3788 • 6 months after 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. 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.
General disorders Asthenia	8.5% 361/4261 • 6 months after 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. 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.	6.4% 242/3788 • 6 months after 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. 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.
General disorders Fatigue	5.6% 238/4261 • 6 months after 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. 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.	1.4% 52/3788 • 6 months after 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. 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.
General disorders Feeling hot	9.5% 403/4261 • 6 months after 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. 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.	7.4% 281/3788 • 6 months after 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. 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.
General disorders Pain	15.6% 663/4261 • 6 months after 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. 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.	9.8% 370/3788 • 6 months after 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. 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.
General disorders Pyrexia	11.0% 467/4261 • 6 months after 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. 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.	5.9% 222/3788 • 6 months after 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. 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.
Infections and infestations Nasopharyngitis	5.4% 232/4261 • 6 months after 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. 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.	2.9% 110/3788 • 6 months after 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. 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.
Metabolism and nutrition disorders Decreased appetite	8.3% 354/4261 • 6 months after 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. 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.	5.1% 195/3788 • 6 months after 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. 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.
Musculoskeletal and connective tissue disorders Arthralgia	12.4% 530/4261 • 6 months after 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. 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.	9.8% 370/3788 • 6 months after 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. 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.
Nervous system disorders Headache	32.9% 1402/4261 • 6 months after 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. 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.	20.3% 770/3788 • 6 months after 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. 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.
Skin and subcutaneous tissue disorders Pruritus	6.0% 256/4261 • 6 months after 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. 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.	3.6% 138/3788 • 6 months after 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. 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.
Gastrointestinal disorders Rash	6.4% 274/4261 • 6 months after 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. 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.	4.1% 155/3788 • 6 months after 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. 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.

Additional Information

Dr. Barbara Mahon

Centers for Disease Control and Prevention

Phone: 404-718-1157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place