A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
NCT ID: NCT03356561
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
100 participants
INTERVENTIONAL
2017-11-26
2019-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1: Ad26.ZIKV.001 5*10^10 Viral Particles (vp)
Participants will receive Ad26.ZIKV.001 at 5\*10\^10 viral particles (vp) via intramuscular (IM) route on Days 1 and 57.
Ad26.ZIKV.001 5*10^10 vp
Participants will receive Ad26.ZIKV.001 at a dose of 5\*10\^10 vp via IM route.
Group 2: Ad26.ZIKV.001 5*10^10 vp and Placebo
Participants will receive Ad26.ZIKV.001 5\*10\^10 vp on Day 1 and placebo on Day 57 via IM route.
Ad26.ZIKV.001 5*10^10 vp
Participants will receive Ad26.ZIKV.001 at a dose of 5\*10\^10 vp via IM route.
Placebo
Participants will receive placebo via IM route.
Group 3: Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at 1\*10\^11 vp via IM route on Days 1 and 57.
Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at a dose of 1\*10\^11 vp via IM route.
Group 4: Ad26.ZIKV.001 1*10^11 vp and Placebo
Participants will receive Ad26.ZIKV.001 1\*10\^11 vp on Day 1 and placebo on Day 57 via IM route.
Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at a dose of 1\*10\^11 vp via IM route.
Placebo
Participants will receive placebo via IM route.
Group 5: Placebo
Participants will receive placebo via IM route on Days 1 and 57.
Placebo
Participants will receive placebo via IM route.
Interventions
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Ad26.ZIKV.001 5*10^10 vp
Participants will receive Ad26.ZIKV.001 at a dose of 5\*10\^10 vp via IM route.
Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at a dose of 1\*10\^11 vp via IM route.
Placebo
Participants will receive placebo via IM route.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges, and additionally within the limits representing Food and Drug Administration (FDA) toxicity Grade 1, the participant may be considered eligible only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after the last study vaccine administration
* Participant must be willing to provide verifiable identification
* All female participants of childbearing potential must have:
1. a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening
2. a negative urine (beta-hCG) pregnancy test immediately prior to each study vaccine administration
Exclusion Criteria
* Participant has traveled to an area with active flavivirus transmission (as per Centers for Disease Control and Prevention \[CDC\]'s 'Zika travel notices') or Zika cautionary areas ('Yellow and Red areas') within 4 weeks before screening
* Participant has chronic active hepatitis B or hepatitis C virus infection, verified at screening by hepatitis B surface antigen (HBsAg) or hepatitis C antibody, respectively
* Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
* Participant received or plans to receive licensed live-attenuated vaccines within 28 days before or after each planned study vaccine administration; licensed inactivated, subunit, or conjugate vaccines within 14 days before or after each planned study vaccine administration
18 Years
50 Years
ALL
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Johnson County Clinical Trials
Lenexa, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Salisch NC, Stephenson KE, Williams K, Cox F, van der Fits L, Heerwegh D, Truyers C, Habets MN, Kanjilal DG, Larocca RA, Abbink P, Liu J, Peter L, Fierro C, De La Barrera RA, Modjarrad K, Zahn RC, Hendriks J, Cahill CP, Leyssen M, Douoguih M, van Hoof J, Schuitemaker H, Barouch DH. A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study of Ad26.ZIKV.001, an Ad26-Vectored Anti-Zika Virus Vaccine. Ann Intern Med. 2021 May;174(5):585-594. doi: 10.7326/M20-5306. Epub 2021 Feb 16.
Other Identifiers
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VAC26911ZIK1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108417
Identifier Type: -
Identifier Source: org_study_id
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