Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses

April 14, 2025 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • 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 - Page 2 of 5 - 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30333
        • Centers for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Non-pregnant
  • Non-immune compromised adults 18 years and older
  • At occupational risk of exposure to live H5N1 viruses
  • Must be eligible for care by the CDC occupational health clinic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Influenza A/H5N1 Vaccine
Two 90ug Doses of Intramuscular Inactivated Influenza A/H5N1 Vaccine
Biological: inactivated influenza A/H5N1 vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Time Frame: 28 days, 56 days, 180 days
28 days, 56 days, 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolyn Bridges, MD, Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2006

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDC-NCIRD-5000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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