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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: Ad26.ZIKV.001 5*10^10 vp; Biological: Ad26.ZIKV.001 1*10^11 vp

Study type: Interventional

Funder types: Industry

Identifiers

NCT03356561

VAC26911ZIK1001 (Other Identifier)

CR108417

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups, including a placebo group

Group 1: Ad26.ZIKV.001 5*10^10 Viral Particles (vp)

Experimental group

Description:

Participants will receive Ad26.ZIKV.001 at 5\*10\^10 viral particles (vp) via intramuscular (IM) route on Days 1 and 57.

Treatment:

Biological: Ad26.ZIKV.001 5*10^10 vp

Group 2: Ad26.ZIKV.001 5*10^10 vp and Placebo

Experimental group

Description:

Participants will receive Ad26.ZIKV.001 5\*10\^10 vp on Day 1 and placebo on Day 57 via IM route.

Treatment:

Biological: Placebo

Biological: Ad26.ZIKV.001 5*10^10 vp

Group 3: Ad26.ZIKV.001 1*10^11 vp

Experimental group

Description:

Participants will receive Ad26.ZIKV.001 at 1\*10\^11 vp via IM route on Days 1 and 57.

Treatment:

Biological: Ad26.ZIKV.001 1*10^11 vp

Group 4: Ad26.ZIKV.001 1*10^11 vp and Placebo

Experimental group

Description:

Participants will receive Ad26.ZIKV.001 1\*10\^11 vp on Day 1 and placebo on Day 57 via IM route.

Treatment:

Biological: Placebo

Biological: Ad26.ZIKV.001 1*10^11 vp

Group 5: Placebo

Placebo Comparator group

Description:

Participants will receive placebo via IM route on Days 1 and 57.

Treatment:

Biological: Placebo