title: Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers.
abstract: BACKGROUND
  The development in an extremely short time of an efficacious and safe vaccine against the pandemi A/H1N1 virus was a challenge that involved the entire scientific community.
  
  
  OBJECTIVE
  To assess the immunological and clinical efficacy of the new H1N1v monovalent influenza vaccine (Focetria Novartis Vaccines, Siena, Italy) in a group of health care workers (HCWs).
  
  
  METHODS
  A total of 148 volunteer HCWs were enrolled between Mid-Novembre 2009 and December 2009. After measuring antibody titers, a single intramuscular dose of 7.5 microg of Focetria monovalent vaccine against A/H1N1/2009 influenza virus with MF59C.1 adjuvant was administered.
  
  
  RESULTS
  Antibody titers (median value) before and after a single dose of vaccine, measured by means of standard beam-agglutination inhibition test (HAI), increased from 32 to 256 (p < 0.001). After vaccination, 79.7% of the subjects showed antibody seroconversion, and in 97.3% seroprotection was achieved. The ratio between the geometric means of antibody titers (GMTR) was 6.69. For the 3 subjects who reported symptoms of ILI (Influenza-like illness), a regular nasal-pharyngeal swab sample was taken to identify the virus type by RT-PCR, the laboratory results of tests performed on these samples were negative for pandemic A/H1N1/2009 virus. During the entire follow-up period of 6 months no severe adverse events occurred.
  
  
  CONCLUSIONS
  The vaccine against pandemic A/H1N1/2009 virus provided protection against the virus and not only contributed to a significant immunization (according to EMEA criteria), but kept all 148 subjects under study free from A/H1N1/2009 influenza illness.
authors: Clinical Unit of Occupational Health, Desio Hospital, Desio (MB), Italy. paolo.mascagni@aovimercate.org
authors: P
authors: P
authors: Mascagni
authors: Elisa
authors: E
authors: Vicenzi
authors: Anna
authors: A
authors: Kajaste-Rudnitski
authors: G
authors: G
authors: Pellicciotta
authors: A
authors: A
authors: Monti
authors: Carla
authors: C
authors: Cervi
authors: Roberta
authors: R
authors: Vitalucci
authors: F
authors: F
authors: Toffoletto
mesh_terms: D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D005260:Female; D006282:Health Personnel; D006801:Humans; D007114:Immunization; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012449:Safety; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines