Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-16 @ 9:33 AM
Study NCT ID:
NCT02860650
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-02', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse events (AEs)', 'timeFrame': 'Up to 28 days after the last vaccination'}, {'measure': 'Number of Participants With Reactogenicity (ie, Solicited Local and Systemic Adverse Events)', 'timeFrame': 'One Week after each study vaccine administration'}, {'measure': 'Number of Participants With Serious Adverse Events', 'timeFrame': 'Up to the end of long-term follow-up (Day 360)'}], 'secondaryOutcomes': [{'measure': 'Binding Antibody Responses Against Ebola Virus (EBOV), Marburg Virus (MARV), and Sudan Virus (SUDV) Glycoproteins (GPs)', 'timeFrame': 'Up to Day 360'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36197845', 'type': 'DERIVED', 'citation': 'Bockstal V, Shukarev G, McLean C, Goldstein N, Bart S, Gaddah A, Anumenden D, Stoop JN, Marit de Groot A, Pau MG, Hendriks J, De Rosa SC, Cohen KW, McElrath MJ, Callendret B, Luhn K, Douoguih M, Robinson C. First-in-human study to evaluate safety, tolerability, and immunogenicity of heterologous regimens using the multivalent filovirus vaccines Ad26.Filo and MVA-BN-Filo administered in different sequences and schedules: A randomized, controlled study. PLoS One. 2022 Oct 5;17(10):e0274906. doi: 10.1371/journal.pone.0274906. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index (BMI) of greater than or equal to (\\>=) 18.5 and less than (\\<) 35.0 kilogram per square meter (kg/m\\^2)\n* Healthy on the basis of physical examination, medical history, and the investigator's clinical judgment\n* All women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[beta-hCG\\]) pregnancy test at screening, have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration\n* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction from the start of screening onwards until at least 3 months after the last vaccination\n* Participant must be available and willing to participate for the duration of the study visits and follow-up\n\nExclusion Criteria:\n\n* Has been vaccinated with a candidate filovirus vaccine\n* Has received any Ad26- or MVA-based candidate vaccines in the past\n* Has been diagnosed with disease caused by Ebola virus (EBOV), Marburg virus (MARV), Sudan virus (SUDV), or Taï Forest virus (TAFV) or exposed to EBOV, MARV, SUDV, or TAFV, including participants who traveled to epidemic filovirus areas in West Africa during the last 2 years (that is, since the start of the last Ebolavirus outbreak) should be excluded from the study\n* Chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively\n* Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (\\>=) 38.0 degree Celsius on Day 1"}, 'identificationModule': {'nctId': 'NCT02860650', 'briefTitle': 'A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Vaccines & Prevention B.V.'}, 'officialTitle': 'A Phase 1, First-in-human Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adult', 'orgStudyIdInfo': {'id': 'CR108144'}, 'secondaryIdInfos': [{'id': 'VAC69120FLV1001', 'type': 'OTHER', 'domain': 'Janssen Vaccines & Prevention B.V.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: AD26.Filo/MVA-BN-Filo or Placebo', 'description': 'Participants will receive Ad26.Filo or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.', 'interventionNames': ['Biological: Ad26.Filo', 'Biological: MVA-BN-Filo', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: MVA-BN-Filo/AD26.Filo or Placebo', 'description': 'Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 57.', 'interventionNames': ['Biological: Ad26.Filo', 'Biological: MVA-BN-Filo', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: MVA-BN-Filo/AD26.Filo or Placebo', 'description': 'Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.Filo or placebo on Day 15.', 'interventionNames': ['Biological: Ad26.Filo', 'Biological: MVA-BN-Filo', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Subset of Group 3: AD26.Filo or Placebo', 'description': 'The first 8 participants in Group 3 who are willing to enroll in the subset for third vaccination, will receive a third vaccination at Day 92. Participants who previously received placebo will receive placebo a third time and participants who previously received MVA-BN-Filo/Ad26.Filo vaccination will receive Ad26.Filo as third vaccination. After enrollment of the 8 participants, the unblinded monitor and unblinded pharmacist will assess whether 7 participants who previously received MVA-BN-Filo/Ad26.Filo vaccination have been enrolled. If less than 7 participants of the active vaccine regimen have been enrolled, 2 additional participants will be enrolled. If at least 7 participants of the active vaccine regimen have been enrolled, no further will be enrolled. The aim is to enroll 7 or 8 participants who will receive Ad26.Filo as third vaccination.', 'interventionNames': ['Biological: Ad26.Filo', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo', 'description': 'Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 57.', 'interventionNames': ['Biological: Ad26.ZEBOV', 'Biological: Placebo', 'Biological: MVA-BN-Filo']}], 'interventions': [{'name': 'Ad26.Filo', 'type': 'BIOLOGICAL', 'description': 'Ad26.Filo intramuscular (IM) injection at a dose of 9\\*10\\^10 viral particles (vp).', 'armGroupLabels': ['Group 1: AD26.Filo/MVA-BN-Filo or Placebo', 'Group 2: MVA-BN-Filo/AD26.Filo or Placebo', 'Group 3: MVA-BN-Filo/AD26.Filo or Placebo', 'Subset of Group 3: AD26.Filo or Placebo']}, {'name': 'MVA-BN-Filo', 'type': 'BIOLOGICAL', 'description': 'MVA-BN-Filo intramuscular (IM) injection at a dose of 5\\*10\\^8 infectious units (Inf U).', 'armGroupLabels': ['Group 1: AD26.Filo/MVA-BN-Filo or Placebo', 'Group 2: MVA-BN-Filo/AD26.Filo or Placebo', 'Group 3: MVA-BN-Filo/AD26.Filo or Placebo']}, {'name': 'Ad26.ZEBOV', 'type': 'BIOLOGICAL', 'description': 'Ad26.ZEBOV intramuscular (IM) injection at a dose of 5\\*10\\^10 vp.', 'armGroupLabels': ['Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'IM injection of 0.9 percent saline.', 'armGroupLabels': ['Group 1: AD26.Filo/MVA-BN-Filo or Placebo', 'Group 2: MVA-BN-Filo/AD26.Filo or Placebo', 'Group 3: MVA-BN-Filo/AD26.Filo or Placebo', 'Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo', 'Subset of Group 3: AD26.Filo or Placebo']}, {'name': 'MVA-BN-Filo', 'type': 'BIOLOGICAL', 'description': 'MVA-BN-Filo intramuscular (IM) injection at a dose of 1\\*10\\^8 Inf U.', 'armGroupLabels': ['Group 4: Ad26.ZEBOV/MVA-BN-Filo or placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Janssen Vaccines & Prevention B.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Vaccines & Prevention B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Vaccines & Prevention B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}