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Virus Vaccine

Influenza A/H5N1 Vaccine for Influenza

Phase 1 & 2
Waitlist Available
Led By Carolyn Bridges, MD
Research Sponsored by Centers for Disease Control and Prevention
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-pregnant
Non-immune compromised adults 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days, 56 days, 180 days
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Influenza

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days, 56 days, 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days, 56 days, 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The 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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Influenza A/H5N1 VaccineExperimental Treatment1 Intervention
Two 90ug Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Centers for Disease Control and PreventionLead Sponsor
874 Previous Clinical Trials
22,477,424 Total Patients Enrolled
Carolyn Bridges, MDPrincipal InvestigatorCenters for Disease Control and Prevention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025