The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Objectives: The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age. The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
48
Undetermined
Alabama Vaccine Research Center (UAB)
Birmingham, Alabama, United States
To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults.
Time frame: 56 day observations with 2 year follow-up
Determination of immunogenicity and correlates of protection based on HI titers in vaccinates
Time frame: 28 days and 56 days post vaccination
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