Abstract
Introduction: The development in an extremely short time of an efficacious and safe vaccine against the pandemic A/H1N1 virus was a challenge that involved the entire scientific community. Aims: 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 μg 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 heamagglutination 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% seroprotecion 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.
| Original language | English |
|---|---|
| Pages (from-to) | 220-229 |
| Number of pages | 10 |
| Journal | Medicina del Lavoro |
| Volume | 103 |
| Issue number | 3 |
| Publication status | Published - May 2012 |
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Keywords
- A/H1N1/2009 virus
- Health care workers
- Pandemic influenza vaccine
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health
Cite this
Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers. / Mascagni, P.; Vicenzi, Elisa; Kajaste-Rudnitski, Anna; Pellicciotta, G.; Monti, A.; Cervi, Carla; Vitalucci, Roberta; Toffoletto, F.
In: Medicina del Lavoro, Vol. 103, No. 3, 05.2012, p. 220-229.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers
AU - Mascagni, P.
AU - Vicenzi, Elisa
AU - Kajaste-Rudnitski, Anna
AU - Pellicciotta, G.
AU - Monti, A.
AU - Cervi, Carla
AU - Vitalucci, Roberta
AU - Toffoletto, F.
PY - 2012/5
Y1 - 2012/5
N2 - Introduction: The development in an extremely short time of an efficacious and safe vaccine against the pandemic A/H1N1 virus was a challenge that involved the entire scientific community. Aims: 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 μg 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 heamagglutination 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% seroprotecion 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.
AB - Introduction: The development in an extremely short time of an efficacious and safe vaccine against the pandemic A/H1N1 virus was a challenge that involved the entire scientific community. Aims: 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 μg 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 heamagglutination 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% seroprotecion 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.
KW - A/H1N1/2009 virus
KW - Health care workers
KW - Pandemic influenza vaccine
UR - http://www.scopus.com/inward/record.url?scp=84861379193&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84861379193&partnerID=8YFLogxK
M3 - Article
C2 - 22838300
AN - SCOPUS:84861379193
VL - 103
SP - 220
EP - 229
JO - Medicina del Lavoro
JF - Medicina del Lavoro
SN - 0025-7818
IS - 3
ER -