Influenza Clinical Trial
Official title:
A Single Center, Open-label, Phase I/II Study of Two 90 Microgram Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
This is a single center, open-label, Phase I/II study in up to 100 adult subjects, aged 18
years and older who are at occupational risk of exposure to live H5N1 viruses. This study is
designed to investigate the safety, reactogenicity, and immunogenicity of two 90 µg doses of
an investigational inactivated influenza A/H5N1 virus vaccine given approximately 28 days
apart. A blood sample will be collected for immunogenicity evaluation prior to each
vaccination. Subjects will maintain a memory aid (appendix C4 and C13) to record oral
temperature and systemic and local AEs for 7 days after immunization. Subjects will be
encouraged to take their temperature around the same time each day. All subjects will
receive a safety follow-up telephone call at 1 to 3 days after each vaccination
(approximately Day 2) to elicit any AE and concomitant medication information. Subjects will
return to the clinic 7 days after each vaccination for assessment of AEs and concomitant
medications, a targeted physical examination (if indicated), and review of the memory aid.
At approximately Day 28 after the first vaccination, subjects will return to the clinic for
evaluation of vital signs, blood sample collection and safety follow-up, confirmation of
eligibility criteria and a second vaccination. Safety follow-up will be identical to that
performed after the first vaccination. At approximately Day 56 (or about 28 days after the
second vaccination), subjects will return to the clinic for immunogenicity blood sample
collection, AE and concomitant medication assessment, and targeted physical examination and
vital sign assessment (if indicated). At approximately Day 180 (6 months after the first
vaccination), subjects will return to the clinic for a final immunogenicity blood sample
collection and safety assessment.
Blood samples collected prior to each vaccination (Days 0 and 28) and on Days 56 and 180
after the first vaccination will be tested at the CDC Influenza Division Laboratory for the
levels of neutralizing and HAI antibodies and CMI responses.
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and
proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers
against the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses
(including frequencies of 4 fold or greater rise in titer; GMTs; and proportions of subjects
achieving protective titers of neutralizing antibody 1 month and 6 months after first dose)
will also be assessed. A secondary outcome measure will be CMI responses evaluated 1 month
after the receipt of each dose of vaccine and 6 months after the receipt of the first dose
of vaccine.
This is a single center, open-label, Phase I/II study in up to 100 adult subjects, aged 18
years and older who are at occupational risk of exposure to live H5N1 viruses. This study is
designed to investigate the safety, reactogenicity, and immunogenicity of two 90 µg doses of
an investigational inactivated influenza A/H5N1 virus vaccine given approximately 28 days
apart. A blood sample will be collected for immunogenicity evaluation prior to each
vaccination. Subjects will maintain a memory aid (appendix C4 and C13) to record oral
temperature and systemic and local AEs for 7 days after immunization. Subjects will be
encouraged to take their temperature around the same time each day. All subjects will
receive a safety follow-up telephone call at 1 to 3 days after each vaccination
(approximately Day 2) to elicit any AE and concomitant medication information. Subjects will
return to the clinic 7 days after each vaccination for assessment of AEs and concomitant
medications, a targeted physical examination (if indicated), and review of the memory aid.
At approximately Day 28 after the first vaccination, subjects will return to the clinic for
evaluation of vital signs, blood sample collection and safety follow-up, confirmation of
eligibility criteria and a second vaccination. Safety follow-up will be identical to that
performed after the first vaccination. At approximately Day 56 (or about 28 days after the
second vaccination), subjects will return to the clinic for immunogenicity blood sample
collection, AE and concomitant medication assessment, and targeted physical examination and
vital sign assessment (if indicated). At approximately Day 180 (6 months after the first
vaccination), subjects will return to the clinic for a final immunogenicity blood sample
collection and safety assessment.
Blood samples collected prior to each vaccination (Days 0 and 28) and on Days 56 and 180
after the first vaccination will be tested at the CDC Influenza Division Laboratory for the
levels of neutralizing and HAI antibodies and CMI responses.
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and
proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers
against the influenza A/H5N1 virus on Day 56. Serum HAI and neutralizing antibody responses
(including frequencies of 4 fold or greater rise in titer; GMTs; and proportions of subjects
achieving protective titers of neutralizing antibody 1 month and 6 months after first dose)
will also be assessed. A secondary outcome measure will be CMI responses evaluated 1 month
after the receipt of each dose of vaccine and 6 months after the receipt of the first dose
of vaccine.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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