Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 11/21/2015 |
Start Date: | August 2015 |
End Date: | May 2016 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults
The study will evaluate the safety and immunogenicity of 3 consistency lots and a high-dose
lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this
study is to demonstrate consistency in the immune responses of participants receiving 3
separate lots of V920 (at release dose) through 28 days postvaccination. Safety of the
vaccines and matching placebo will be evaluated for all participants through 6 months
postvaccination.
lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this
study is to demonstrate consistency in the immune responses of participants receiving 3
separate lots of V920 (at release dose) through 28 days postvaccination. Safety of the
vaccines and matching placebo will be evaluated for all participants through 6 months
postvaccination.
Inclusion Criteria:
- Not of reproductive potential, or of reproductive potential and agrees to avoid
becoming pregnant or impregnating a partner for 2 months following study vaccination.
Exclusion Criteria:
- Is currently participating in or has participated in an interventional clinical trial
with an investigational compound or device within 90 days of participation in this
trial.
- Has previously been randomized in another clinical trial and received V920 or any
other Ebola vaccine.
- Has been exposed to Ebola virus at any time prior to study entry.
- Is pregnant or breastfeeding or plans to conceive within 2 months following study
vaccination.
- Has direct household exposure to a pregnant or lactating woman at the time of
participation in this trial.
- Has known or suspected impairment of immunological function (e.g., HIV positive).
- Has direct household exposure to a person with known or suspected impairment of
immunological function (e.g., HIV positive).
- Has a clinically significant history of intravenous (IV) drug abuse within 12 months
prior to study entry.
- Has a known allergy/sensitivity or contraindication to investigational product(s) or
its/their excipients (e.g., albumin).
- Has a history of malignancy <=5 years prior to study entry except for adequately
treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
child) who is investigational site or sponsor staff directly involved with this
trial.
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