Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers

P. Mascagni, Elisa Vicenzi, Anna Kajaste-Rudnitski, G. Pellicciotta, A. Monti, Carla Cervi, Roberta Vitalucci, F. Toffoletto

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish
Pages (from-to)220-229
Number of pages10
JournalMedicina del Lavoro
Volume103
Issue number3
Publication statusPublished - May 2012

Fingerprint

Influenza Vaccines
Pandemics
Vaccines
H1N1 Subtype Influenza A Virus
Delivery of Health Care
Safety
Antibodies
Human Influenza
Viruses
Orthomyxoviridae
Nose
Italy
Volunteers
Immunization
Vaccination
Polymerase Chain Reaction
focetria

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 journalArticle

Mascagni, P, Vicenzi, E, Kajaste-Rudnitski, A, Pellicciotta, G, Monti, A, Cervi, C, Vitalucci, R & Toffoletto, F 2012, 'Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers', Medicina del Lavoro, vol. 103, no. 3, pp. 220-229.
Mascagni, P. ; Vicenzi, Elisa ; Kajaste-Rudnitski, Anna ; Pellicciotta, G. ; Monti, A. ; Cervi, Carla ; Vitalucci, Roberta ; Toffoletto, F. / Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers. In: Medicina del Lavoro. 2012 ; Vol. 103, No. 3. pp. 220-229.
@article{06d3e2bc82b24cccb08d065a3ed8eafe,
title = "Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers",
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 {\circledR} 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 {\circledR} 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.",
keywords = "A/H1N1/2009 virus, Health care workers, Pandemic influenza vaccine",
author = "P. Mascagni and Elisa Vicenzi and Anna Kajaste-Rudnitski and G. Pellicciotta and A. Monti and Carla Cervi and Roberta Vitalucci and F. Toffoletto",
year = "2012",
month = "5",
language = "English",
volume = "103",
pages = "220--229",
journal = "Medicina del Lavoro",
issn = "0025-7818",
publisher = "Mattioli 1885 S.p.A.",
number = "3",

}

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 -