Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Completed · Not applicable

Conditions studied: Influenza

In brief

This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.

Key facts

Study ID

NCT01044095

Run by

Armed Forces Research Institute of Medical Sciences, Thailand

People needed

26

Starts

2009-11-01

Expected to finish

2012-06-01

Last updated by the study team

2013-07-23

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18-49 years.
• Healthy as determined by the PI or designate
• Willing to give informed consent.
• Willing to attend follow-up appointments and undergo study procedures.
• US passport holder residing in Bangkok
• If military, have a letter of approval for participation from the chain of command (Unit Commander).

You may not qualify if…

• History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
• Severe or life-threatening reaction to any previous vaccine.
• History of chronic respiratory illness, including asthma and sinusitis.
• History of heart disease
• History of kidney disease
• Metabolic disease such as diabetes
• Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
• History of Guillain-Barre syndrome.
• Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
• Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
• Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
• Blood donation within the preceding 3 months, or screening hemoglobin value of <12.5 g/dl.
• Receipt of blood products including immunoglobulins within the preceding 3 months.
• Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
• Receipt of any antiviral agents within 48 hours of vaccine administration.
• HIV positive on screening blood tests.
• Any other condition that in the opinion of the study investigator warrants exclusion from the study.

Where it is running

• United States Embassy Medical Unit — Bangkok, Thailand

Full record on ClinicalTrials.gov

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