Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044095

Enrollment

Registered

2010-01-07

Start date

2009-11-30

Completion date

2012-06-30

Last updated

2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

seasonal influenza vaccine, avian influenza H5N1, cross reactivity, prime boost

Brief summary

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.

Interventions

BIOLOGICALFluMist® live, attenuated, intranasal seasonal influenza vaccine

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

BIOLOGICALFluzone® inactivated influenza virus vaccine

Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

Healthy volunteers

Yes

Inclusion criteria

1. Aged 18-49 years. 2. Healthy as determined by the PI or designate 3. Willing to give informed consent. 4. Willing to attend follow-up appointments and undergo study procedures. 5. US passport holder residing in Bangkok 6. If military, have a letter of approval for participation from the chain of command (Unit Commander).

Exclusion criteria

1. History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine. 2. Severe or life-threatening reaction to any previous vaccine. 3. History of chronic respiratory illness, including asthma and sinusitis. 4. History of heart disease 5. History of kidney disease 6. Metabolic disease such as diabetes 7. Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual. 8. History of Guillain-Barre syndrome. 9. Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records). 10. Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine. 11. Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up. 12. Blood donation within the preceding 3 months, or screening hemoglobin value of \<12.5 g/dl. 13. Receipt of blood products including immunoglobulins within the preceding 3 months. 14. Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs, 15. Receipt of any antiviral agents within 48 hours of vaccine administration. 16. HIV positive on screening blood tests. 17. Any other condition that in the opinion of the study investigator warrants exclusion from the study.

Design outcomes

Primary

Measure	Time frame
antibody titers	12 weeks

Secondary

Measure	Time frame
safety of 2 doses of seasonal influenza vaccine in healthy adults	12 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026