UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan
Number of subjects who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus.
Time frame: Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)
Frequencies of AEs including vaccine-related reactogenicity events.
Time frame: Throughout study period: Day0 to 42
To explore T-cell response in the subset of subjects after each vaccination as determined by proliferation and cytokine production capacity of T-cells re-stimulate by H5N1 A/Vietnam/1203/2004 recombinant virus antigens.
Time frame: Day0, Day 21 and Day 42
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