St. Jude Open Label H5 Trial

NCT00311675 | Completed Phase 1

• 1 other identifier: 05-0130
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how antibodies (proteins that fight infection) are made after you receive the new H5N1 flu vaccine. The new H5N1 vaccine will be given to 50 healthy adult lab workers, aged 18 years and older. Subjects will receive two 90mcg injections (shots in the arm) of the vaccine about 1 month apart. Subjects will maintain a memory aid to record oral temperature and any response to the vaccine for 7 days after each immunization. Subjects will be contacted by telephone 1 to 3 days after vaccination. They will return to the clinic on Day 7. Blood will be drawn before each vaccination and on Days 56 and 180. Subjects may be involved in the study for about 6 months. It is anticipated that the vaccine will provide safe protection against influenza H5N1.

Conditions

Influenza

Keywords

influenza, A/H5N1, vaccine

Outcome Measures

Primary Outcomes (3)

• Adverse event (AE) or serious AE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment).

  1 - 3 days after each vaccination to review any AEs and SAEs; approximately 1 week after each vaccination review any AEs and collect for 28 days following the 2nd dose of vaccine. SAEs will be collected throughout the study through day 180.

• Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers.

  28 days after receipt of 2nd dose of vaccine.

• Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers against the influenza A/H5N1 virus.

  28 days after receipt of 2nd dose of vaccine.

Secondary Outcomes (3)

• Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group.

  1 month and 7 months after receipt of the first dose of vaccine.

• Geometric mean titer (GMT) and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group.

  1 month and 7 months after receipt of the first dose of vaccine.

• Development of serum antibody responses against antigenically drifted variants of H5N1 influenza viruses.

  Serum for immunogenicity evaluations will be obtained prior to the 1st vaccination (day 0) and prior to the 2nd vaccination (day 28), and on days 56 and 180.

Study Arms (1)

1

EXPERIMENTAL

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

Interventions

Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) BIOLOGICAL

Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in single-dose vials containing 90-mcg/mL A/H5N1 HA. Dosage is two 90 mcg doses administered intramuscularly separated by approximately 28 days.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory personal with potential exposure to live H5N1 viruses.
• Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to each dose of vaccine), aged 18 years and older.
• Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
• Is in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
• Able to understand and comply with planned study procedures.
• Provides informed consent prior to any study procedures and is available for all study visits.

You may not qualify if:

• Has a known allergy to eggs or other components of the vaccine.
• Has a known allergy or sensitivity to latex (in the stopper).
• Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
• Is undergoing immunosuppression as a result of an underlying illness or treatment.
• Has an active neoplastic disease or a history of any hematologic malignancy.
• Is using oral or parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs.
• Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
• Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 6-month study period.
• Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 31805, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 27, 2010

Record last verified: 2008-07

Locations

US (1)