Trial Outcomes & Findings for Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo (NCT NCT02661464)

Last Updated: 2024-01-02

Results Overview

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

677 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2024-01-02

Participant Flow

As none of the participants met Cohort 2 eligibility criteria pre-specified in the protocol, therefore no participants were enrolled in Cohort 2. So the results were only presented for Cohorts 1 and 3.

Participant milestones

Participant milestones
Measure	Cohort 1: Ad26.ZEBOV + MVA-BN-Filo Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 1: Placebo Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 3: Ad26.ZEBOV + MVA-BN-Filo Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.	Cohort 3: Placebo Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.
Overall Study STARTED	617	57	2	1
Overall Study Full Analysis Set	614	53	2	1
Overall Study COMPLETED	295	0	1	0
Overall Study NOT COMPLETED	322	57	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Ad26.ZEBOV + MVA-BN-Filo Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 1: Placebo Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 3: Ad26.ZEBOV + MVA-BN-Filo Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.	Cohort 3: Placebo Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.
Overall Study Lost to Follow-up	28	0	0	0
Overall Study Withdrawal by Subject	3	1	0	0
Overall Study Participants terminated prematurely	288	52	1	1
Overall Study Participants who had no post-baseline visits.	3	4	0	0

Baseline Characteristics

Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Ad26.ZEBOV + MVA-BN-Filo n=614 Participants Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 1: Placebo n=53 Participants Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 3: Ad26.ZEBOV + MVA-BN-Filo n=2 Participants Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.	Cohort 3: Placebo n=1 Participants Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.	Total n=670 Participants Total of all reporting groups
Age, Continuous	35.6 years STANDARD_DEVIATION 13 • n=5 Participants	37 years STANDARD_DEVIATION 13.44 • n=7 Participants	1.2 years STANDARD_DEVIATION 0.41 • n=5 Participants	1.3 years STANDARD_DEVIATION NA • n=4 Participants	35.6 years STANDARD_DEVIATION 13.2 • n=21 Participants
Sex: Female, Male Female	254 Participants n=5 Participants	24 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	279 Participants n=21 Participants
Sex: Female, Male Male	360 Participants n=5 Participants	29 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	391 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	569 Participants n=5 Participants	46 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	618 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	249 Participants n=5 Participants	20 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	272 Participants n=21 Participants
Race (NIH/OMB) White	345 Participants n=5 Participants	28 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	373 Participants n=21 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment BURKINA FASO	68 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	79 Participants n=21 Participants
Region of Enrollment FRANCE	139 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	157 Participants n=21 Participants
Region of Enrollment KENYA	56 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	56 Participants n=21 Participants
Region of Enrollment TANZANIA, UNITED REPUBLIC OF	16 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment UGANDA	25 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment UNITED KINGDOM	170 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	180 Participants n=21 Participants
Region of Enrollment UNITED STATES OF AMERICA	140 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	154 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Population: Full analysis set (FAS) included all participants who were enrolled in this study and had at least one post-baseline visit, regardless of the occurrence of protocol deviations.

Outcome measures

Outcome measures
Measure	Cohort 1: Ad26.ZEBOV + MVA-BN-Filo n=614 Participants Male or female participants who received adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) vaccine and/or Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 1: Placebo n=53 Participants Male or female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2 or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after Day 1 of vaccination (including participant's original study duration).	Cohort 3: Ad26.ZEBOV + MVA-BN-Filo n=2 Participants Children born to female participants who received Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.	Cohort 3: Placebo n=1 Participants Children born to female participants who received placebo matching to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase 1, 2, or 3 (NCT02313077, NCT02325050, NCT02376426, NCT02376400, NCT02416453, NCT02564523, NCT02543567, NCT02543268) clinical study of Ad26.ZEBOV and/or MVA-BN-Filo and became pregnant with estimated conception within 28 days after vaccination with placebo matching to MVA-BN-Filo or within 3 months after vaccination with placebo matching to Ad26.ZEBOV in a Phase 1, 2, or 3 clinical study were enrolled in this study. Participants did not receive any vaccination in the current study. Participants were followed up for safety up to 60 months after birth.
Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs)	49 Participants	1 Participants	2 Participants	1 Participants

Adverse Events

Cohort 1: Ad26.ZEBOV + MVA-BN-Filo

Serious events: 49 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1: Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Ad26.ZEBOV + MVA-BN-Filo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Medical Leader

Janssen Vaccines & Prevention B.V.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER