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OpenTrials
Completed

NCT Number: NCT01044095

Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United States Embassy Medical Unit

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

FluMist® live, attenuated, intranasal seasonal influenza vaccine

Biological

FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)

Fluzone® inactivated influenza virus vaccine

Biological

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Primary outcomes

  1. antibody titers

    Time frame: 12 weeks

Secondary outcomes

  1. safety of 2 doses of seasonal influenza vaccine in healthy adults

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Armed Forces Research Institute of Medical Sciences, Thailand

Other Gov

Registry information

Official study title

Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Jul 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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