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

NCT02416453 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR107227VAC52150EBL20012015-000596-27
• Study Type: interventional
• Target: 423
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.

Conditions

Ebola Viral Disease

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

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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.

  Up to Day 365

• 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.

  Up to Day 365

• 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.

  7 days post-dose 1 (Day 8)

• 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.

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

• 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.

  7 days post-dose 1 (Day 8)

• 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.

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

Secondary Outcomes (6)

• Number of Participants With Unsolicited Adverse Events (Group 4)

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

• Number of Participants With Serious Adverse Events (Group 4)

  Up to Day 180

• Number of Participants With Immediate Reportable Events (Group 4)

  Up to Day 180

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

  7 days after each vaccination (Up to Day 8)

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

  7 days after each vaccination (Up to Day 8)

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

MVA-BN-Filo BIOLOGICAL

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

Group 1; Group 2; Group 3

Ad26.ZEBOV BIOLOGICAL

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

Group 1; Group 2; Group 3

Placebo BIOLOGICAL

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
• Must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the laboratory screening tests are outside the normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
• Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 2 years or lesser than or equal to \[\<=\] 45 years of age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level \>40 international unit per milliliter \[IU/L\]); permanently sterilized (for example, bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
• Woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
• Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to screening must be willing to use condoms for sexual intercourse beginning prior to enrollment

You may not qualify if:

• Having received any candidate Ebola vaccine
• Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
• Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based vaccine in the past
• Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines including known allergy to egg, egg products and aminoglycosides
• Presence of acute illness or temperature greater than or equal to 38.0 C on Day 1

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University of Oxford: collaborator

Study Sites (11)

Unknown Facility

Créteil, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Pierre-Bénite, France

Location

Unknown Facility

Rennes, France

Location

Unknown Facility

Saint-Etienne, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Tours, France

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Oxford, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

Related Publications (3)

• Lacabaratz C, Durand M, Wiedemann A, Foucat E, Surenaud M, Krief C, Guillaumat L, Robinson C, Luhn K, Bockstal V, Thiebaut R, Richert L, Levy Y. Innate and Cellular Immune Response to the Ebola Vaccine Ad26.ZEBOV, MVA-BN-Filo: An Ancillary Study of the EBL2001 Phase 2 Trial. J Infect Dis. 2025 Feb 4;231(1):230-240. doi: 10.1093/infdis/jiae360.

  PMID: 39012798 DERIVED

• Barry H, Lhomme E, Surenaud M, Nouctara M, Robinson C, Bockstal V, Valea I, Somda S, Tinto H, Meda N, Greenwood B, Thiebaut R, Lacabaratz C. Helminth exposure and immune response to the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. PLoS Negl Trop Dis. 2024 Apr 11;18(4):e0011500. doi: 10.1371/journal.pntd.0011500. eCollection 2024 Apr.

  PMID: 38603720 DERIVED

• 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.

  PMID: 33217361 DERIVED

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

• Inserm Clinical Trials

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: June 15, 2015
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Locations

GB (3); FR (8)