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

Sponsor

Janssen Vaccines & Prevention B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT03356561

Collaborator

(none)

100

Enrollment

Locations

Arms

21.9

Actual Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 510^10 viral particles (vp) and 110^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: Ad26.ZIKV.001 510^10 vp Biological: Ad26.ZIKV.001 110^11 vp Biological: Placebo	Phase 1

Study Design

Study Type:

Interventional

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 :

Nov 26, 2017

Actual Primary Completion Date :

Sep 23, 2019

Actual Study Completion Date :

Sep 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Ad26.ZIKV.001 510^10 Viral Particles (vp) Participants will receive Ad26.ZIKV.001 at 510^10 viral particles (vp) via intramuscular (IM) route on Days 1 and 57.	Biological: *Ad26.ZIKV.001 510^10 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.001 510^10 vp and Placebo Participants will receive Ad26.ZIKV.001 510^10 vp on Day 1 and placebo on Day 57 via IM route.	Biological: *Ad26.ZIKV.001 510^10 vp** Participants will receive Ad26.ZIKV.001 at a dose of 510^10 vp via IM route. Other Names: JNJ-66684657 Biological: Placebo* Participants will receive placebo via IM route.
Experimental: Group 3: Ad26.ZIKV.001 110^11 vp Participants will receive Ad26.ZIKV.001 at 110^11 vp via IM route on Days 1 and 57.	Biological: *Ad26.ZIKV.001 110^11 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.001 110^11 vp and Placebo Participants will receive Ad26.ZIKV.001 110^11 vp on Day 1 and placebo on Day 57 via IM route.	Biological: *Ad26.ZIKV.001 110^11 vp** Participants will receive Ad26.ZIKV.001 at a dose of 110^11 vp via IM route. Other Names: 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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) [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).
Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) [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).
Number of Participants with Solicited Systemic AEs [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).
Number of Participants with Solicited Systemic AEs [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).
Number of Participants with Unsolicited AEs [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).
Number of Participants with Unsolicited AEs [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).
Number of Participants with Serious Adverse Events (SAEs) [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.
Number of Participants with Immediate Reportable Events (IREs) [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

Neutralizing Antibodies to the Vaccine Strain (or Other Strain) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johnson County Clinical Trials	Lenexa	Kansas	United States	66219
2	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Vaccines & Prevention B.V.

ClinicalTrials.gov Identifier:

NCT03356561

Other Study ID Numbers:

CR108417
VAC26911ZIK1001

First Posted:

Nov 29, 2017

Last Update Posted:

Oct 15, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 15, 2019

Arm	Intervention/Treatment
Experimental: Group 1: Ad26.ZIKV.001 510^10 Viral Particles (vp) Participants will receive Ad26.ZIKV.001 at 510^10 viral particles (vp) via intramuscular (IM) route on Days 1 and 57.	Biological: *Ad26.ZIKV.001 510^10 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.001 510^10 vp and Placebo Participants will receive Ad26.ZIKV.001 510^10 vp on Day 1 and placebo on Day 57 via IM route.	Biological: *Ad26.ZIKV.001 510^10 vp** Participants will receive Ad26.ZIKV.001 at a dose of 510^10 vp via IM route. Other Names: JNJ-66684657 Biological: Placebo* Participants will receive placebo via IM route.
Experimental: Group 3: Ad26.ZIKV.001 110^11 vp Participants will receive Ad26.ZIKV.001 at 110^11 vp via IM route on Days 1 and 57.	Biological: *Ad26.ZIKV.001 110^11 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.001 110^11 vp and Placebo Participants will receive Ad26.ZIKV.001 110^11 vp on Day 1 and placebo on Day 57 via IM route.	Biological: *Ad26.ZIKV.001 110^11 vp** Participants will receive Ad26.ZIKV.001 at a dose of 110^11 vp via IM route. Other Names: 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.