Last reviewed · How we verify

NCT02661464

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

Terminated Phase 3 Results posted Last updated 2 January 2024
What this trial tests

Phase 3 trial testing Ad26.ZEBOV in Hemorrhagic Fever, Ebola in 677 participants. Terminated before completion.

Timeline
31 May 2016
Primary endpoint
13 December 2021
13 December 2021

Quick facts

Lead sponsorJanssen Vaccines & Prevention B.V.
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment677
Start date31 May 2016
Primary completion13 December 2021
Estimated completion13 December 2021
Sites16 locations across France, Tanzania, Burkina Faso, United Kingdom, Kenya, United States, Uganda

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Vaccines & Prevention B.V. — full company profile →

Who can join

Adults 0 to 71, any sex, with Hemorrhagic Fever, Ebola. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs) Primary · Up to 60 months

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.

GroupValue95% CI
Cohort 1: Ad26.ZEBOV + MVA-BN-Filo49
Cohort 1: Placebo1
Cohort 3: Ad26.ZEBOV + MVA-BN-Filo2
Cohort 3: Placebo1

Adverse events — posted to ClinicalTrials.gov

Time frame: Cohorts 1 and 3: Up to 60 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Ad26.ZEBOV + MVA-BN-Filo
Serious: 49/614 (8%)
Deaths: 0/614
Cohort 1: Placebo
Serious: 1/53 (2%)
Deaths: 0/53
Cohort 3: Ad26.ZEBOV + MVA-BN-Filo
Serious: 2/2 (100%)
Deaths: 0/2
Cohort 3: Placebo
Serious: 1/1 (100%)
Deaths: 0/1

Serious adverse events (57 terms)

ReactionSystemCohort 1: Ad26.ZEBOV + MVA…Cohort 1: PlaceboCohort 3: Ad26.ZEBOV + MVA…Cohort 3: Placebo
Inguinal HerniaGastrointestinal disorders
MalariaInfections and infestations
Cholecystitis AcuteHepatobiliary disorders
Abortion SpontaneousPregnancy, puerperium and perinatal conditions
HyperthyroidismEndocrine disorders
CataractEye disorders
Colitis UlcerativeGastrointestinal disorders
Duodenal UlcerGastrointestinal disorders
HaemorrhoidsGastrointestinal disorders
Medical Device DiscomfortGeneral disorders
CholangitisHepatobiliary disorders
Food AllergyImmune system disorders
Abscess LimbInfections and infestations
AppendicitisInfections and infestations
BacteraemiaInfections and infestations
CellulitisInfections and infestations
Chronic SinusitisInfections and infestations
Covid-19Infections and infestations
CystitisInfections and infestations
Hepatitis AInfections and infestations
MeaslesInfections and infestations
Pulmonary TuberculosisInfections and infestations
PyelonephritisInfections and infestations
SepsisInfections and infestations
SinusitisInfections and infestations

Most-reported serious reactions: Inguinal Hernia, Malaria, Cholecystitis Acute, Abortion Spontaneous, Hyperthyroidism, Cataract, Colitis Ulcerative, Duodenal Ulcer.

Data from ClinicalTrials.gov NCT02661464 adverse events section.

Sponsor's own description

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ebola: Lessons on Vaccine Development.
    Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
  2. Ebola vaccines in clinical trial: The promising candidates.
    Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
  3. Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
    Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
  4. Ebola virus disease candidate vaccines under evaluation in clinical trials.
    Martins KA, Jahrling PB, Bavari S, Kuhn JH. · · 2016 · cited 37× · PMID 27160784 · DOI 10.1080/14760584.2016.1187566
  5. Distinct Immunogenicity and Efficacy of Poxvirus-Based Vaccine Candidates against Ebola Virus Expressing GP and VP40 Proteins.
    Lázaro-Frías A, Gómez-Medina S, Sánchez-Sampedro L, Ljungberg K, et al · · 2018 · cited 33× · PMID 29514907 · DOI 10.1128/jvi.00363-18
  6. Ebolavirus: Comparison of Survivor Immunology and Animal Models in the Search for a Correlate of Protection.
    Longet S, Mellors J, Carroll MW, Tipton T. · · 2020 · cited 13× · PMID 33679690 · DOI 10.3389/fimmu.2020.599568
  7. NF-κB as an Important Factor in Optimizing Poxvirus-Based Vaccines against Viral Infections.
    Struzik J, Szulc-Dąbrowska L. · · 2020 · cited 8× · PMID 33260450 · DOI 10.3390/pathogens9121001
  8. Design of a novel multi-epitope vaccine against Marburg virus using immunoinformatics studies.
    Al-Zayadi FQJ, Shakir AS, Kareem AS, Ghasemian A, et al · · 2024 · cited 5× · PMID 38970027 · DOI 10.1186/s12896-024-00873-2

Verify or expand the search:

Other trials of Ad26.ZEBOV

Trials testing the same drug.

Other Janssen Vaccines & Prevention B.V. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02661464.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing