A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 4/4/2019 |
Start Date: | November 26, 2017 |
End Date: | October 3, 2019 |
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.
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.
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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