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

October 14, 2019 updated by: Janssen Vaccines & Prevention B.V.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clinical Trials
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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: Placebo
Participants will receive placebo 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 Names:
  • JNJ-66684657
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
7 days post vaccination on Day 1 (Day 1 up to Day 8)
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).
7 days post vaccination on Day 57 (Day 57 up to Day 64)
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).
7 days post vaccination on Day 1 (Day 1 up to Day 8)
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).
7 days post vaccination on Day 57 (Day 57 up to Day 64)
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).
28 days post vaccination on Day 1 (Day 1 up to Day 29)
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).
28 days post vaccination on Day 57 (Day 57 up to Day 85)
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.
First vaccination to the end of the study (approximately up to 12 months)
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.
First vaccination to the end of the study (approximately up to 12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Days 1, 8, 15, 29, 57, 64, 71, 85, 239, and 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Vaccines & Prevention B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108417
  • VAC26911ZIK1001 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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