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A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT03356561
Recruitment Status : Active, not recruiting
First Posted : November 29, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5*10^10 viral particles (vp) and 1*10^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.ZIKV.001 5*10^10 vp Biological: Ad26.ZIKV.001 1*10^11 vp Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, First-in-Human Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Actual Study Start Date : November 26, 2017
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: 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.
Biological: Ad26.ZIKV.001 5*10^10 vp
Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.
Other Name: JNJ-66684657

Experimental: 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.
Biological: Ad26.ZIKV.001 5*10^10 vp
Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.
Other Name: JNJ-66684657

Biological: Placebo
Participants will receive placebo via IM route.

Experimental: 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.
Biological: Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.
Other Name: JNJ-66684657

Experimental: 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.
Biological: Ad26.ZIKV.001 1*10^11 vp
Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.
Other Name: JNJ-66684657

Biological: Placebo
Participants will receive placebo via IM route.

Placebo Comparator: Group 5: Placebo
Participants will receive placebo via IM route on Days 1 and 57.
Biological: Placebo
Participants will receive placebo via IM route.




Primary Outcome Measures :
  1. Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) [ Time Frame: 7 days post vaccination on Day 1 (Day 1 up to Day 8) ]
    Number of participants with solicited injection site (local) AEs will be evaluated. Solicited local AEs including pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary from Day 1 to Day 8. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  2. Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) [ Time Frame: 7 days post vaccination on Day 57 (Day 57 up to Day 64) ]
    Number of participants with solicited injection site (local) AEs will be evaluated. Solicited local AEs including pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary from Day 57 to Day 64. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  3. Number of Participants with Solicited Systemic AEs [ Time Frame: 7 days post vaccination on Day 1 (Day 1 up to Day 8) ]
    Number of participants with solicited systemic AEs will be evaluated. Following solicited systemic AEs: fever, chills, headache, fatigue, nausea, myalgia, and arthralgia, will be noted in the participant diary from Day 1 to Day 8. Systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  4. Number of Participants with Solicited Systemic AEs [ Time Frame: 7 days post vaccination on Day 57 (Day 57 up to Day 64) ]
    Number of participants with solicited systemic AEs will be evaluated. Following solicited systemic AEs: fever, chills, headache, fatigue, nausea, myalgia, and arthralgia, will be noted in the participant diary from Day 1 to Day 8. Systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  5. Number of Participants with Unsolicited AEs [ Time Frame: 28 days post vaccination on Day 1 (Day 1 up to Day 29) ]
    Number of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  6. Number of Participants with Unsolicited AEs [ Time Frame: 28 days post vaccination on Day 57 (Day 57 up to Day 85) ]
    Number of participants with unsolicited AEs will be evaluated. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  7. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination to the end of the study (approximately up to 12 months) ]
    Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

  8. Number of Participants with Immediate Reportable Events (IREs) [ Time Frame: First vaccination to the end of the study (approximately up to 12 months) ]
    Number of Participants with IREs will be evaluated. Any events of neuroimmunologic significance will be categorized as IREs.


Secondary Outcome Measures :
  1. Neutralizing Antibodies to the Vaccine Strain (or Other Strain) [ Time Frame: Days 1, 8, 15, 29, 57, 64, 71, 85, 239, and 365 ]
    Zika virus (ZIKV) neutralizing titers of the vaccine-induced immune response will be assessed using a virus neutralization assay (VNA).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be healthy, without significant medical illness, on the basis of physical examination, medical history, and vital signs performed at screening
  • 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 a known history of flavivirus infection or previous receipt of flavivirus vaccine such as dengue virus (DENV) types 1-4, yellow fever virus (YFV), Japanese encephalitis virus (JEV), and West Nile virus (WNV)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356561


Locations
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03356561     History of Changes
Other Study ID Numbers: CR108417
VAC26911ZIK1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No