Clinical trial NCT01044095: Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: seasonal influenza vaccine
avian influenza H5N1
cross reactivity
prime boost
Lead sponsor: Armed Forces Research Institute of Medical Sciences, Thailand
Sponsor class: OTHER_GOV
First posted: 2010-01-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: antibody titers
timeFrame: 12 weeks
Secondary outcomes:
measure: safety of 2 doses of seasonal influenza vaccine in healthy adults
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: United States Embassy Medical Unit
Study officials:
affiliation: Armed Forces Research Institute of Medical Sciences, Thailand
name: Delia B Bethell, BM BCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, Tyner SD, Fukuda MM, Walsh DS, Pichyangkul S. Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial. PLoS One. 2013;8(3):e59674. doi: 10.1371/journal.pone.0059674. Epub 2013 Mar 26.