H9 Priming Study in Healthy Adults

NCT00617331 | Completed Phase 2

• 3 other identifiers: 06-0073N01AI30039CN01AI30039
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to different strengths of the H9N2 flu vaccine. This information may guide vaccine development for this virus as well as other bird flu viruses that have infected humans. Study participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The assignment of vaccines to participants is governed by chance. Study procedures may include medical history, physical exam, and blood samples. Study participation duration is about 7 months.

Conditions

Influenza

Keywords

vaccine, priming, influenza, flu, A/H9N2

Outcome Measures

Primary Outcomes (1)

• Frequency of 4-fold or greater serum hemagglutination inhibition assay (HAI) and neutralizing antibody rises in both age groups to the homologous vaccine antigen.

  28 Days after the first vaccine dose.

Secondary Outcomes (7)

• Frequencies of 4-fold or greater increase in titer between pre- and post-immunization samples.

  28 days after the second vaccination (day 56).

• Frequencies and severity of solicited and local and systemic adverse events in each vaccine dosage/age group.

  7 days after each inoculation.

• Proportion of subjects in each age/vaccine dosage group that achieves an HAI titer of at least 32.

  28 days after each vaccination (Day 28, Day 56).

• Frequencies and GMT of serum HAI and serum neutralizing antibody against a homologous A/H9N2 virus.

  One month after each vaccination (Day 28, Day 56).

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

  Duration of study.

Study Arms (2)

Dose 7.5 mcg

EXPERIMENTAL

7.5 micrograms of vaccine administered on Day 0 and Day 28.

Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine

Dose 30 mcg

EXPERIMENTAL

30 micrograms of vaccine administered on Day 0 and Day 28.

Biological: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine

Interventions

Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine BIOLOGICAL

Inactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms.

Dose 30 mcg; Dose 7.5 mcg

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 38 years, inclusive, or 44-59 years, inclusive.
• Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (e.g., barrier method, abstinence, and licensed hormonal methods) from at least 30 days prior to enrollment and for at least 3 months after receipt of dose 2.
• Able to understand and comply with planned study procedures.
• Provide informed consent prior to initiation of any study procedures and be available for all study visits.

You may not qualify if:

• Has a known allergy to eggs or other components of the vaccine including thimerosal.
• Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential), is breast-feeding, or has the intention to become pregnant within 3 months of receipt of their second dose of vaccine.
• 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 (greater than 800 micrograms/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 a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
• Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
• Has an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination.
• Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to each vaccination in the study, or expects to receive an experimental agent during the 7-month study period.
• Prior receipt of influenza A/H9N2 vaccine, other than the present study.
• Is planning to enroll in another clinical trial at any time during the study period (approximately 7 months total).
• Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.

Sponsors & Collaborators

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

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 18, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

US (1)