Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine

Completed · Phase 1

Conditions studied: Influenza, Virus Diseases

In brief

In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.

Key facts

Study ID

NCT00722774

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

22

Last updated by the study team

2008-11-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• General good health
• Available for the duration of the trial
• If female, agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.

You may not qualify if…

• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
• Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
• Previous enrollment in an H2N2 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H2N2 influenza A virus (serum HAI titer >1:8)
• Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
• Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
• Any condition that, in the opinion of the investigator, would interfere with the study
• History of anaphylaxis
• Allergy to oseltamivir as determined by subject report
• Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
• History of Guillain-Barre Syndrome
• HIV-1-infected
• Hepatitis C-infected
• Positive hepatitis B virus surface antigen
• Known immunodeficiency syndrome
• Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
• Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
• History of a surgical splenectomy
• Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
• Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
• Travel to the Southern Hemisphere within 14 days prior to study entry
• Travel on a cruise ship within 14 days prior to study entry
• Direct contact with live poultry within the 14 days prior to the study or after study completion.
• Receipt of another investigational vaccine or drug within 30 days prior to study entry

Where it is running

• Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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