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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: Ad26.ZIKV.001 5*10^10 vp
* Biological: Ad26.ZIKV.001 1*10^11 vp
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Ad26.ZIKV.001 5*10^10 Viral Particles (vp)<br>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<br>* Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.<br>* Other names: JNJ-66684657;|
| Experimental: Group 2: Ad26.ZIKV.001 5*10^10 vp and Placebo<br>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<br>* Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.<br>* Other names: JNJ-66684657;Biological: Placebo<br>* Participants will receive placebo via IM route.<br>|
| Experimental: Group 3: Ad26.ZIKV.001 1*10^11 vp<br>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<br>* Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.<br>* Other names: JNJ-66684657;|
| Experimental: Group 4: Ad26.ZIKV.001 1*10^11 vp and Placebo<br>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<br>* Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.<br>* Other names: JNJ-66684657;Biological: Placebo<br>* Participants will receive placebo via IM route.<br>|
| Placebo Comparator: Group 5: Placebo<br>Participants will receive placebo via IM route on Days 1 and 57. | Biological: Placebo<br>* Participants will receive placebo via IM route.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Solicited Injection Site (Local) Adverse Events (AEs) | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing Antibodies to the Vaccine Strain (or Other Strain) | 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 |