Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola (NCT NCT04186000)
NCT ID: NCT04186000
Last Updated: 2026-07-14
Results Overview
To assess binding antibody levels against the EBOV GP using FANG ELISA
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
699 participants
Primary outcome timeframe
21 days post-dose 2 vaccination on Day 78
Results posted on
2026-07-14
Participant Flow
On day 0, in maximum groups of 40 individuals, registered healthcare providers working in the Boende health district were invited to attend a workshop where the informed consent form was explained. If they were willing to participate in the study after attending the workshop, they were asked to return the next day for screening and consent (day 1).
Participant milestones
| Measure |
Group 1
Booster vaccine with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) given at 1 year after the first dose of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.
|
Group 2
Booster vaccine with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) given at 2 years after the first dose of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
350
|
348
|
|
Overall Study
Vaccinated dose 1 (Ad26.ZEBOV)
|
350
|
348
|
|
Overall Study
Vaccinated dose 2 per protocol (MVA-BN-Filo)
|
343
|
342
|
|
Overall Study
Boosted per protocol (Ad26.ZEBOV)
|
314
|
310
|
|
Overall Study
COMPLETED
|
321
|
322
|
|
Overall Study
NOT COMPLETED
|
29
|
26
|
Reasons for withdrawal
| Measure |
Group 1
Booster vaccine with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) given at 1 year after the first dose of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.
|
Group 2
Booster vaccine with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) given at 2 years after the first dose of the Ad26.ZEBOV, MVA-BN-Filo vaccine regimen.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
12
|
|
Overall Study
Physician Decision
|
0
|
4
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Moved out of study area
|
12
|
6
|
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of a Heterologous Vaccine Regimen Against Ebola
Baseline characteristics by cohort
| Measure |
Group 1
n=350 Participants
Booster vaccine with Ad26.ZEBOV after 1 year
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
Group 2
n=348 Participants
Booster vaccine with Ad26.ZEBOV after 2 years
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 11.5 • n=9 Participants
|
44.6 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
45.0 years
STANDARD_DEVIATION 12.0 • n=267 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
164 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
260 Participants
n=9 Participants
|
274 Participants
n=27 Participants
|
534 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
350 Participants
n=9 Participants
|
348 Participants
n=27 Participants
|
698 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
Congo, The Democratic Republic of the
|
350 participants
n=9 Participants
|
348 participants
n=27 Participants
|
698 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 21 days post-dose 2 vaccination on Day 78To assess binding antibody levels against the EBOV GP using FANG ELISA
Outcome measures
| Measure |
Group 1
n=343 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
Group 2
n=341 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
|---|---|---|
|
Binding Antibody Responses Post-dose 2 Vaccination With MVA-BN-Filo
|
3854.6 ELISA Units/mL
Interval 3340.7 to 4447.5
|
4505.2 ELISA Units/mL
Interval 3903.8 to 5199.3
|
SECONDARY outcome
Timeframe: Serious Adverse Events: 6 months post-booster (up to 1.5 years for group 1, up to 2.5 years for group 2); All other adverse events: 7 days post 1-year (group 1) or 2-year (group 2) boosterTo assess serious adverse events (SAE) during the entire clinical study (up to 1.5 years for group 1, up to 2.5 years for group 2) and to assess solicited local and systemic adverse events until 7 days post booster/dose 3 vaccination with Ad26.ZEBOV
Outcome measures
| Measure |
Group 1
n=350 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
Group 2
n=348 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
|---|---|---|
|
Safety of a Heterologous Vaccine Regimen Utilizing Ad26.ZEBOV as Dose 1, MVA-BN-Filo as Dose 2 and Ad26.ZEBOV as Booster Dose 3
|
15 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 7 days post-booster vaccination on Day 372 (Group 1) or Day 737 (Group 2)To assess binding antibody levels against the EBOV GP using FANG ELISA
Outcome measures
| Measure |
Group 1
n=314 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
Group 2
n=310 Participants
Binding antibody responses post-dose 2 vaccination with MVA-BN-Filo per protocol.
|
|---|---|---|
|
Binding Antibody Responses After Booster Vaccination With Ad26.ZEBOV
|
10781.6 ELISA Units/mL
Interval 9354.4 to 12426.4
|
10746.9 ELISA Units/mL
Interval 9208.7 to 12542.0
|
Adverse Events
Group 1
Serious events: 15 serious events
Other events: 174 other events
Deaths: 2 deaths
Group 2
Serious events: 32 serious events
Other events: 166 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Group 1
n=314 participants at risk；n=350 participants at risk
Booster vaccine with Ad26.ZEBOV after 1 year
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
Group 2
n=310 participants at risk；n=348 participants at risk
Booster vaccine with Ad26.ZEBOV after 2 years
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.57%
2/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
2.0%
7/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Appendicitis
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
1.1%
4/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
General disorders
Asthenia
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Renal and urinary disorders
Calculus bladder
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.57%
2/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.57%
2/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.57%
2/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.57%
2/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
HIV infection
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
Malaria
|
1.1%
4/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.86%
3/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia haemorrhage
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
Pneumonia
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Infections and infestations
Typhoid fever
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
1.1%
4/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Renal and urinary disorders
Urinary retention
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.29%
1/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.00%
0/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/350 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
0.29%
1/348 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
Other adverse events
| Measure |
Group 1
n=314 participants at risk；n=350 participants at risk
Booster vaccine with Ad26.ZEBOV after 1 year
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
Group 2
n=310 participants at risk；n=348 participants at risk
Booster vaccine with Ad26.ZEBOV after 2 years
Ad26.ZEBOV vaccine: The booster vaccination with Ad26.ZEBOV (5x10\^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
|
|---|---|---|
|
General disorders
Local solicited adverse event
|
30.3%
95/314 • Number of events 104 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
30.6%
95/310 • Number of events 126 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
General disorders
Systemic adverse event
|
42.4%
133/314 • Number of events 252 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
41.0%
127/310 • Number of events 313 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
|
General disorders
Unsolicited adverse events
|
20.4%
64/314 • Number of events 94 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
25.5%
79/310 • Number of events 132 • Serious adverse events were collected from enrollment until 6 months after the last received dose (ie, group 1: 1 year and 6 months follow-up period & group 2: 2 years and 6 months follow-up period). Adverse events were collected using a participant diary for 7 days after booster vaccination only.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place