Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus

Armed Forces Research Institute of Medical Sciences, Thailand

Status: Completed

Conditions: Influenza

Treatments: Biological: Fluzone® inactivated influenza virus vaccine; Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01044095

HSRRB No. A-15223 (Other Identifier)

WRAIR1525

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Autologous prime boost regimen 1

Active Comparator group

Description:

FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days)

Treatment:

Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine

Autologous prime boost regimen 2

Active Comparator group

Description:

Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days)

Treatment:

Biological: Fluzone® inactivated influenza virus vaccine

Heterologous prime boost regimen 1

Experimental group

Description:

FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later

Treatment:

Biological: Fluzone® inactivated influenza virus vaccine

Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine

Heterologous prime boost regimen 2

Experimental group

Description:

Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later

Treatment:

Biological: Fluzone® inactivated influenza virus vaccine

Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine