A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults

Browse trials for

• Hemorrhagic Fever, Ebola 102
• Virus Diseases 913

Keywords

• Healthy
• Ebola viruses
• Ebola Viral Disease (EVD)
• Filoviruses
• Monovalent vaccine
• Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
• Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo)
• Safety
• Immunogenicity
• Inserm and University of Oxford

Hemorrhagic Fever, Ebola

102 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.

This study's enrollment of 423 is above the median of 91 across 79 interventional studies indexed under Hemorrhagic Fever, Ebola.

Lead sponsor

Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.

Study arms

• Experimental
  Group 1

  Participants will receive intramuscular (IM) injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 29.

  Biological: MVA-BN-Filo · Biological: Ad26.ZEBOV · Biological: Placebo

• Experimental
  Group 2

  Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 57.

  Biological: MVA-BN-Filo · Biological: Ad26.ZEBOV · Biological: Placebo

• Experimental
  Group 3

  Participants will receive IM injection of Ad26.ZEBOV/Placebo on Day 1 followed by IM injection of MVA-BN-Filo/Placebo on Day 85.

  Biological: MVA-BN-Filo · Biological: Ad26.ZEBOV · Biological: Placebo

Interventions

• BiologicalMVA-BN-Filo

  One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit \[Inf. U.\] on Day 29, 57, or 85.

• BiologicalAd26.ZEBOV

  One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.

• BiologicalPlacebo

  One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.

Primary outcomes

1. Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3)

   An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.

   Time frame: Up to 42-day post dose 2 visit (Day 1 to Day 127)

2. Number of Participants With Serious Adverse Events (Groups 1, 2 and 3)

   A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

   Time frame: Up to Day 365

3. Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3)

   The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.

   Time frame: Up to Day 365

4. Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

   Time frame: 7 days post-dose 1 (Day 8)

5. Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

   Time frame: 7 days post-dose 2 (Up to Day 92)

6. Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

   Time frame: 7 days post-dose 1 (Day 8)

7. Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

   Time frame: 7 days post-dose 2 (Up to Day 92)

Secondary outcomes

1. Number of Participants With Unsolicited Adverse Events (Group 4)

   An AE is any untoward medical occurrence in a clinical study subject administered a medicinal product, it does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal product. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.

   Time frame: Up to 28-day post dose 1 (Day 29)

2. Number of Participants With Serious Adverse Events (Group 4)

   A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

   Time frame: Up to Day 180

3. Number of Participants With Immediate Reportable Events (Group 4)

   The following neuroinflammatory disorders were considered immediate reportable events which had to be reported to the sponsor within 24 hours of becoming aware of the event. Neuroinflammatory disorders included: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.

   Time frame: Up to Day 180

4. Number of Participants With Solicited Local Adverse Events (Group 4)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site.

   Time frame: 7 days after each vaccination (Up to Day 8)

5. Number of Participants With Solicited Systemic Adverse Events (Group 4)

   An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills.

   Time frame: 7 days after each vaccination (Up to Day 8)

6. Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA) (Groups 1, 2 and 3)

   GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) (36.11 ELISA units/mL). The outcome measure was planned to be reported at 21-day post dose 2. Therefore, the results are reported for Group 1, 2 and 3 only.

   Time frame: At 21-days post dose 2 (Day 50 for Group 1; Day 78 for Group 2; and Day 106 for Group 3)

Baseline characteristics

Publications

• Pollard AJ, Launay O, Lelievre JD, Lacabaratz C, Grande S, Goldstein N, Robinson C, Gaddah A, Bockstal V, Wiedemann A, Leyssen M, Luhn K, Richert L, Betard C, Gibani MM, Clutterbuck EA, Snape MD, Levy Y, Douoguih M, Thiebaut R; EBOVAC2 EBL2001 study group. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2021 Apr;21(4):493-506. doi: 10.1016/S1473-3099(20)30476-X. Epub 2020 Nov 17. PubMed 33217361 ↗

Study documents

• Statistical analysis plan · May 30, 2018
• Study protocol · Apr 20, 2017

Documents are hosted by the registry — open the source record to download them.