H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers
United States105 participantsStarted 2012-09
Plain-language summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Males and females 18 to 49 years of age.
* Must be in good general health as confirmed by a medical history and physical exam, vital signs, and screening laboratories conducted no more than 30 days prior to study injection administration.
* Female subjects of childbearing potential, regardless of birth control history, must have a negative serum pregnancy test at screening, a negative urine pregnancy test on the day of each study injection, must not be breast-feeding or lactating, and are required to consistently use one of the following methods of contraception through the first three months of the study: hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence (as confirmed by the investigator); or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that H5-VLP + GLA AF or H5-VLP alone might have in a fetus or newborn infant. The subject must have no plan to become pregnant during the first three months of the study period. Females who are post-menopausal (no spotting at all) for at least one (1) year will not require a pregnancy test.
* The following screening laboratory blood tests must have values within the normal ranges (as provided by each clinical site) or not clinically significant as determined by the Principal Inve…