Yearly licensing studies from 1997 to 2007 of the inactivated whole virus seasonal influenza vaccine fluval--a useful approach to pandemic vaccine development even in less well developed countries?
OBJECTIVE
Seasonal vaccination has been consistently shown to significantly reduce morbidity and mortality because of influenza epidemics, even in healthy, working adults. Here we report the results of the yearly licensing studies of the past 11 influenza seasons (1997-2007) with a trivalent, inactivated whole virus vaccine with an aluminum phosphate adjuvant system.


METHODS
Sixty healthy volunteers per age group (18-60 years and 60 years and older) were enrolled to receive vaccination each year, thus, a total of 1080 subjects were studied. Serum antibody titers were measured by hemagglutination inhibition (HI).


RESULTS
The vaccine met the criteria for licensing each year, meaning seroprotection (achievement of an HI titer of >1:40 in >70% of subjects); seroconversion, i.e. a >4-fold increase in HI antibody titer, or reaching a titer of >1:40, in >40% of subjects; and an increase in geometric mean titers by >2.5-fold. Side effects were rare and mild. The same method was used to produce a pre-pandemic vaccine against influenza A (H5N1), which has been shown to be safe and immunogenic in humans.


CONCLUSIONS
We conclude that the method presented is safe, effective and may serve as a useful approach to seasonal and pandemic vaccine production even in less well-developed countries by means of technological transfer.
Vajo
Zoltan
Z
National Center for Allergy and Immunology, Budapest, Hungary.
Kosa
Lajos
L
Szilvasy
Istvan
I
Pauliny
Zsuzsanna
Z
Bartha
Kálmán
K
Visontay
Ildiko
I
Jankovics
Mate
M
Kis
Agnes
A
Jankovics
Istvan
I
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017607:Aluminum Compounds / Q000008:administration & dosage / Q000494:pharmacology; D000914:Antibodies, Viral / Q000097:blood; D017277:Drug Approval; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage / Q000494:pharmacology; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000276:Adjuvants, Immunologic; D017607:Aluminum Compounds; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D010710:Phosphates; D015164:Vaccines, Inactivated; C012714:aluminum phosphate