Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults

November 19, 2007 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic

Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

According to the World Health Organization, the current pandemic risk associated with avian influenza H5N1 infection is serious, as an increasing number of humans are infected. Currently, H5N1 influenza transmission occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily among humans. The development of a safe and effective vaccine is necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca).

This study will last approximately 16 weeks. Participation in this study includes a hospital stay in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days prior to each vaccination. A targeted physical exam will occur daily following each vaccination until discharge. Participants will not be discharged until nasal washes are negative. Vital signs measurement will be done at least twice daily for the duration of the inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each vaccination. Blood and urine collection will occur at selected timepoints throughout the study.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

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
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health

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

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health
  • Available for the duration of the study
  • Willing to use acceptable forms of contraception for the duration of the study

Exclusion Criteria:

  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
  • Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
  • Previously enrolled in an H5N1 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibitor [HI] titer greater than 1:8)
  • Illegal drug use or dependency determined by urine test
  • History of severe allergic reaction
  • Allergy to oseltamivir
  • Asthma or reactive airways disease within 2 years prior to study entry
  • History of Guillain-Barre syndrome
  • HIV infected
  • Hepatitis C virus infected
  • Positive for hepatitis B surface antigen (HBsAg)
  • Known immunodeficiency syndrome
  • Use of corticosteroid or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
  • Live vaccines within 4 weeks prior to study vaccination
  • Killed vaccines within 2 weeks prior to study vaccination
  • Absence of spleen
  • Blood products within 6 months prior to study vaccination
  • Current smoker unwilling to stop smoking for the duration of the study
  • Have traveled to the Southern Hemisphere or Asia within 14 days prior to study vaccination
  • Have traveled on a cruise ship within 14 days prior to study vaccination
  • Work in the poultry industry
  • Other investigational vaccine or drug within 30 days prior to study vaccination
  • Allergy to eggs or egg products
  • Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
  • Have family member with immunodeficiency-related condition
  • Other condition that, in the opinion of the investigator, may interfere with the study
  • Pregnancy or breastfeeding

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Two, 0.5 ml doses of vaccine in nasal spray form administered at study entry and sometime between 4 and 8 weeks after initial vaccination
Biological: H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Intranasal vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, defined as the frequency of vaccine-related reactogenicity events
Time Frame: During the acute monitoring (in-patient) phase of the study
During the acute monitoring (in-patient) phase of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity, determined by anti-H5N1 antibody titer
Time Frame: At Days 0, 7, 9, and 28 with respect to vaccination
At Days 0, 7, 9, and 28 with respect to vaccination

Collaborators and Investigators

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 18, 2007

First Posted (Estimate)

June 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2007

Last Update Submitted That Met QC Criteria

November 19, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR 239

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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