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

Clinical Unit of Occupational Health, Desio Hospital, Desio (MB), Italy.
La Medicina del lavoro (Impact Factor: 0.55). 05/2012; 103(3):220-9.
Source: PubMed


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.
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).
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.
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.
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.

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    ABSTRACT: During April-June 2010, the Kenya Ministry of Public Health and Sanitation distributed free monovalent influenza A(H1N1)pdm09 vaccines to health care personnel (HCP) and other vulnerable groups. We conducted a prospective, cohort study among HCP to characterize influenza A(H1N1)pdm09 vaccine uptake, and to assess influenza A(H1N1)pdm09 vaccine effectiveness. We enrolled HCP from 5 hospitals and followed them for 6 months. At enrollment, we asked HCP if they had received the influenza A(H1N1)pdm09 vaccine and their reasons for their decision. We administered weekly questionnaires to participants about respiratory symptoms suffered during the previous week. Participants who had acute respiratory illness were asked to contact our surveillance clinician and nasopharyngeal and oropharyngeal specimens were collected and later tested for influenza by real-time reverse-transcriptase polymerase-chain-reaction. Vaccine effectiveness was estimated by comparing the incidence of acute respiratory illness, absenteeism from work due to respiratory illness and laboratory-confirmed influenza among vaccinated and unvaccinated HCP. We enrolled 3803 HCP from the five hospitals; 64% received influenza vaccine. Vaccinated HCP were more likely to develop acute respiratory illness (ARI) and more likely to report missed days of work due to respiratory illness compared to non-vaccinated HCP (adjusted incidence rate ratio (aIRR) 1.50, 95% confidence intervals (CI): 1.33-1.70) and (aIRR 2.02, 95% CI: 1.41-2.88), respectively. Of 531 samples collected from vaccinated and non-vaccinated HCP, 30 were influenza A and 3 were influenza B. Two influenza A(H1N1)pdm09 subtypes were isolated; one from vaccinated and the other from non-vaccinated HCP. A majority of Kenyan HCP surveyed reported receiving the influenza A(H1N1)pdm09 vaccine. Because of low circulation of influenza A(H1N1)pdm09 virus during the study period, vaccine effectiveness could not be determined. The findings of increased ARI events and missed days of work among vaccinated HCP were likely confounded by vaccine-seeking behavioral factors.
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