Human Papilloma Virus Vaccination and Cervical Screening in the Italian Regions: An Overview of the Current State of the Art.

Human Papilloma Virus (HPV) infection and HPV-related cancers can be prevented through vaccinations and mass cervical screening programmes. The Ministry of Health in Italy provides recommendations on primary and secondary prevention of HPV-related diseases, but the 19 Italian regions and 2 autonomous provinces have organisational and decision-making autonomy, with differences in the strategies for offering prevention. The aim of this study is to describe the HPV vaccination and cervical screening offered in all Italian regions. Regional official documents up until 31 December 2021 were first identified. Subsequently, primary and secondary prevention experts from each region were interviewed to validate the previously collected data. The National Immunisation Plan (NIP) 2017-2019 recommends HPV vaccination from the age of 11 for both sexes, with a coverage target of 95%. HPV vaccination is offered free of charge or co-payment. All regions have screening programmes for cervical cancer, using PAP or HPV-DNA tests every three to five years. All regions have an electronic registry for vaccination and screening status. All regions have developed awareness-raising campaigns. It is important to harmonise regional policies with the implementation of information systems integration. The collected data could enhance both regional and national public health initiatives, bolstering the resilience of vaccination programs.

Knowledge, attitude and behaviours towards food sustainability in a group of Italian consumers. A cross-sectional study.

Sustainability is crucial for transforming the food system, addressing environmental and nutrition issues and depends on consumer perceptions and values. This cross-sectional study investigates the relationship between sustainability attitudes, knowledge, and eating behaviours. Nearly half reported high level of knowledge regarding food sustainability while 24% expressed high attitude towards food sustainability. Women reported higher levels of knowledge and attitude towards food sustainability. Logistic regression analyses, adjusted for age, sex, and education, revealed that using public transport, biking, or walking was significantly associated with higher odds of having a more positive overall attitude towards food sustainability (OR = 1.77). The overall knowledge score was a strong predictor of a positive overall attitude score (OR = 2.11). Examining individual knowledge-related items, almost all were associated with higher levels of knowledge, except those regarding food and environment interaction. These findings underline a complex scenario where consumers' awareness and knowledge highly influence the applicability of sustainable food choices.

An Italian Validation of the 5-Item Attitudes to Mental Illness Questionnaire (AMIQ): A Useful Tool for Rapid Assessment of Stigma, Acceptance, and Tolerance.

Stigma negatively impacts individuals, families, and communities, affecting relationships, education, and employment and leading to an additional burden on mental health. Assessing public attitudes towards people with mental health conditions is crucial, especially in terms of public health. Therefore, the Attitudes to Mental Illness Questionnaire (AMIQ) was validated and adapted to the Italian cultural context. Translation followed four phases, involving bilingual speakers, comparison, back-translation, and expert review. In the pre-test phase, the questionnaire was administered to 21 participants anonymously. The validation test involved 213 subjects. Statistical analyses included exploratory and confirmatory factor analysis, and McDonald's Omega and Cronbach's alpha to assess the internal consistency. The results indicate good internal consistency (Omega = 0.71; Alpha = 0.72), and confirmatory factor analysis (CFI = 0.971) validated the questionnaire's construct. The study's findings align with the original validation, underscoring the questionnaire's robustness. Overall, understanding public attitudes is crucial for public health interventions combating stigma and fostering positive attitudes.

Social network characteristics and well-being in Italy: insights from the PHRASI Study.

Background: Mental well-being should be prioritized in public health as it represents a valuable resource for individuals and communities, influencing behavior, social cohesion and social inclusion. The support individuals receive from their social networks can have a significant impact on mental well-being. This study used data from the Public Health Residents' Anonymous Survey in Italy, a nationwide cross-sectional survey. The objective was to assess the level of well-being among the Public Health Residents and investigate the association between the social network characteristics and the well-being in this population. Study design: The current cross-sectional study targeted 1,600 public health residents enrolled in various Italian public health specialization schools between June 14 and July 26, 2022. Methods: Participants self-reported both functional and structural characteristics of social network. Well-being was assessed using the WHO-5 well-being index. Linear regression models, adjusted for age and sex, were applied to examine the association between WHO-5 score and social network characteristics. Results: Out of 379 participants, 51.5% reported bad well-being. Those with bad well-being are more likely women, experience lower peer-to-peer and supervisor support, face higher work-to-private life interference, and less frequently have a partner. Greater peer-to-peer support (ß=1.13, 95% CI=0.68; 1.57), and increased supervisor support (ß=1.26, 95% CI=0.86; 1.67), were associated with higher levels of well-being. Conversely, higher work-to-private life interference was associated with lower perceived well-being. Having a partner resulted in a better perceived well-being (ß=1.96, 95% CI=0.94; 2.98). In logistic regression analysis, higher peer-to-peer support (OR=0.68, 95% CI = 0.55;0.85) greater supervisor support (OR=0.60, 95% CI=0.49;0.74) and having a partner (OR=0.51, 95% CI = 0.32;0.82) were associated with reduced odds of bad well-being. Conversely, increased WLI was associated with higher odds of bad well-being (OR=1.47, 95% CI = 1.19;1.82). Conclusions: The characteristics of an individual's social network play a crucial role in her/his well-being and should be considered both in personal and professional contexts when aimed to enhance mental well-being in communities.

Costs and healthcare utilisation due to respiratory syncytial virus disease in paediatric patients in Italy: a systematic review.

OBJECTIVES: Respiratory syncytial virus (RSV) is a frequent cause of acute lower respiratory infection in children, imposing a substantial economic burden on healthcare systems. This systematic review aimed to assess the economic burden and healthcare utilisation of RSV in children aged 0-59 months in Italy. STUDY DESIGN: Systematic review. METHODS: A systematic search of PubMed, Embase, Scopus, and the International HTA Database, including studies published in English or Italian, was conducted between January 2000 and July 2022. Inclusion criteria required studies to be conducted in Italy and provide data on the economic costs and healthcare resource utilisation related to RSV infections. RESULTS: Out of 20,845 records screened, 18 articles met the inclusion criteria. Only one study provided comprehensive data on RSV disease costs, including hospitalisation, diagnostic tests, and medical procedures for infants with RSV-bronchiolitis. The mean cost per inpatient was higher for RSV-positive children (€5753.43 ± €2041.62) than that for RSV-negative children. Additionally, five studies reported a median length of hospital stay of 5 days for RSV-infected children, and four studies indicated a higher frequency of intensive care unit admissions for RSV-infected children than for those with other viral infections. CONCLUSIONS: This is the first systematic review to examine the economic burden and healthcare utilisation of RSV in children aged 0-59 months in Italy. While limited data were available, the findings underscore the urgency to conduct further research and gather additional evidence on the costs and healthcare resource utilisation associated with RSV infections. Such efforts are essential for informing the development of effective prevention strategies for paediatric RSV infections in Italy.

Social Network Characteristics and Depressive Symptoms of Italian Public Health Medical Residents: The Public Health Residents' Anonymous Survey in Italy (PHRASI).

Despite the high impact of the COVID-19 pandemic on social interactions and healthcare workers' (HWs') mental health, few studies have investigated the association between social network characteristics and HWs' mental health, particularly during the pandemic. Therefore, we aimed to assess the associations between public health residents' (PHRs') social network characteristics and depression. We used data from the Public Health Residents' Anonymous Survey in Italy (PHRASI), a nationwide cross-sectional study. Social network characteristics were self-reported. Depressive symptoms were assessed using the nine-item Patient Health Questionnaire. Linear and logistic models adjusted for age, sex, physical activity, and alcohol were used. A moderation analysis by sex was also performed. A total of 379 PHRs participated in the survey (58% females, median age of 30 years). More peer-to-peer (odds ratio OR = 0.62 (0.47-0.83)) and supervisor support (OR = 0.49 (0.36-0.68)), more social participation ((OR) = 0.36 95% CI (0.25-0.50)), and having a partner (OR = 0.49 (0.25-0.96)) were significantly associated with a lower risk of clinically relevant depressive symptoms. Work-to-private-life interference was significantly associated with a higher risk of clinically relevant depressive symptoms (OR = 1.77 (1.28-2.45)). Promoting a supportive work environment and social participation as well as reducing work-to-private life interference can contribute to reducing the high burden among PHRs.

Assessing vaccine hesitancy and health literacy using a new Italian vaccine confidence index and a modified Italian medical term recognition test: A cross-sectional survey on Italian parents.

The decline in children's vaccination coverage and the resurgence of preventable infectious diseases draw attention to parents' vaccine hesitancy. Our study introduces two validated tools to independently assess vaccine hesitancy and health literacy among parents with school-age children. We developed a Vaccine Confidence Index (VCI) from 10 Likert items, exploring their relationships through exploratory and confirmatory factor analyses. We modified the IMETER (Italian medical term recognition test) to measure health literacy. We assessed the internal consistency of the modified IMETER and the 10 Likert items using Cronbach's alpha test (α) and McDonald's omega total coefficient (ω) with good results (ω = 0.92, α = 0.90; ω = 0.87, α = 0.82 respectively). We used these tools within a questionnaire conducted on 743 parents recruited from pediatric clinic waiting rooms in Italy, collecting demographic data, information sources on vaccines and vaccine-preventable diseases knowledge. The VCI resulting from factor analyses consisted of six items on a ten-point Likert scale, reflecting the ratio of positive to negative items. The survey revealed significant variations in the VCI according to individual features such as education, use of social networks, or Health institutions as sources of information. Multivariate logistic regression identified an association between vaccine intention and the VCI. Health literacy was functional for 91.2% of participants, but knowledge about vaccine-preventable diseases was generally low. The VCI showed no significant association with health literacy and vaccine-preventable diseases knowledge. The VCI and the modified IMETER effectively assess vaccination attitude and health literacy, offering valuable public health tools for tailoring vaccination campaigns to hesitant population subgroups.

Human Respiratory Syncytial Virus Epidemiological Burden in Pediatric Outpatients in Italy: A Systematic Review.

BACKGROUND: Human respiratory syncytial virus (hRSV) is a key contributor to lower respiratory tract infections (LRTIs), affecting children aged 0-5 years and often leading to outpatient visits, emergency department utilization, and hospitalization. With the development of hRSV vaccines for mitigation, understanding the epidemiological impact of hRSV infections among 0-5-year-old pediatric outpatients in Italy is crucial. METHODS: This systematic review conducted searches on PubMed, Embase, Scopus, and the International HTA Database, yielding 20,845 English and Italian records from January 2000 to July 2022. RESULTS: Six eligible articles were identified following inclusion and exclusion criteria. These studies demonstrated hRSV-positivity proportions ranging from 18% to 41% in pediatric outpatients with respiratory infections. However, data comparability was hindered by diverse diagnostic approaches, data sources, sample populations, and study designs. Notably, hRSV-positivity showed temporal variability, rising from 23.8% (2001-2002) to 40.6% (2019-2020). This trend could stem from evolving epidemiological factors, heightened clinician awareness in hRSV diagnosis, or more sensitive molecular techniques. CONCLUSION: As the first review of its kind, this study underscores the need for more comprehensive data to inform effective preventive strategies against hRSV-related burdens in pediatric outpatients.

Efficacy of HPV Vaccination Regarding Vulvar and Vaginal Recurrences in Previously Treated Women: The Need for Further Evidence.

Vulvar and vaginal cancers are relatively rare cancers, but their incidence is increasing worldwide. Overall, 78% of vaginal cancers and 25% of vulvar cancers are associated with Human papillomavirus (HPV) infection. Immunization could be an option for the management of these cases. We researched and assessed the evidence on the efficacy of HPV vaccination administered to women previously treated with surgery, radiotherapy, or chemotherapy with respect to the recurrence of vulvovaginal disease. From 2006 to November 2022, only one study evaluated the efficacy of HPV vaccination with respect to preventing vulvovaginal recurrences in treated women and showed that a quadrivalent HPV vaccine administered after the surgical treatment of vulvar high-grade squamous intraepithelial lesion (HSIL) can reduce vulvar recurrence of the disease. Therefore, the efficacy of HPV vaccination with respect to vulvovaginal recurrence is still an unexplored field. Further studies are needed to produce stronger evidence in order to appropriately support interventions to protect women's health.

Effects of the learning curve on operative time and lymph node harvesting during robotic gastrectomy.

BACKGROUND: Gastric cancer is the fifth most frequent cancer globally. The introduction of minimally invasive surgery for gastric cancer aimed at reducing post-operative morbidity and hospital length of stay. Although the role of laparoscopic gastrectomy has been established, robotic gastric surgery has only recently gained popularity. The purpose of this study was to evaluate, with a multidimensional analysis, the learning curve of a single surgeon with extensive experience in laparoscopic gastrectomy. METHODS: We prospectively collected data from 104 gastric cancer patients who underwent surgery with a robotic approach from June 2015 to June 2019 by a single surgeon. We performed 21 total gastrectomies (TGs) and 83 subtotal gastrectomies (STGs). A D2 lymphadenectomy was performed in all the patients. Proximal and distal resection margins were tumoour-free in all patients. There were no intraoperative complications, and no conversions occurred. RESULTS: The plateau of the learning curve based on harvesting lymph nodes and operative time was not reached for TG. The learning curve of operative time for STG could be divided into three different phases: an early or learning phase from 1 to 27 cases, an intermediate or proficiency phase from 28 to 48 cases, and a late or mastery phase from 49 to 83 cases. The learning curve for harvesting lymph nodes was achieved after 41 cases in the STG group. CONCLUSION: This study shows that robotic gastrectomy is a complex procedure with a significant multiphasic learning curve. Nevertheless, the robotic learning curve seems to be more rapid than that of conventional laparoscopy. Most importantly, our results suggest that the robotic technique can provide oncological adequacy in terms of lymph node harvesting even in the very first phase of the learning curve.

Depressive Symptoms of Public Health Medical Residents during the COVID-19 Pandemic, a Nation-Wide Survey: The PHRASI Study.

Depression is a widespread condition, which increased during the COVID-19 pandemic among healthcare workers as well. The large workload of the pandemic response also affected Public Health Residents (PHRs) who played an important role in infection prevention and control activities. This work aims to assess depression in Italian PHRs, based on data collected through the PHRASI (Public Health Residents' Anonymous Survey in Italy) study. In 2022, 379 PHRs completed the self-administered questionnaire containing Patient Health Questionnaire-9 to evaluate clinically relevant depressive symptoms (PHQ-9 ≥ 10). Multivariate logistic regression shows that the intention (aOR = 3.925, 95% CI = (2.067-7.452)) and the uncertainty (aOR = 4.949, 95% CI = (1.872-13.086)) of repeating the test to enter another postgraduate school/general practitioner course and the simultaneous attendance of two traineeships (aOR = 1.832, 95% CI = (1.010-3.324)) are positively related with depressive symptoms. Conversely, the willingness to work in the current traineeship place (aOR = 0.456, 95% CI = (0.283-0.734)) emerged as a protective factor. Similar results were obtained considering mild-to-severe (PHQ-9 ≥ 5) depressive symptoms and/or stratifying by sex. The findings, suggesting the protective role of job satisfaction toward depression, might entail future interventions to improve the learning experience and promote work-life balance.

Communicating with Patients about COVID-19 Vaccination: A Qualitative Study on Vaccinators in Tuscany Region, Italy.

The rapid development of the vaccine and the infodemia have challenged communication about COVID-19 vaccines. This study aims to characterize-through the experience of vaccinators-the challenges faced during COVID-19 vaccination consultations and the communication strategies adopted. A qualitative study was conducted on COVID-19 vaccinators in Tuscany, Italy. Face-to-face interviews were conducted and examined by thematic analysis. In total, 30 vaccinators were interviewed. Four main themes emerged. The first highlighted distinct profiles of users' attitudes toward COVID-19 vaccination. Barriers and promoters of vaccine uptake emerged in the second theme: concerns over the vaccine, excessive exposure to information, and a lack of clear guidance from institutions were the main factors behind hesitancy. The third theme highlighted users' information-seeking behaviors; vaccinators observed that users ideologically opposed to the vaccine (IOV) unconsciously seek information that confirms their theories. The last theme comprised communication strategies for dealing with hesitancy. Empathy, first-hand examples, transparency, and tailored communication style appear to be effective in building vaccine trust. Lastly, the impossibility of developing a decision-making partnership with IOVs was noticed. These findings may help to better characterize public attitudes toward COVID-19 vaccination and highlight key communication principles and strategies to foster vaccine confidence.

Public Health Residents' Anonymous Survey in Italy (PHRASI): Study Protocol for a Cross-Sectional Study for a Multidimensional Assessment of Mental Health and Its Determinants.

The COVID-19 pandemic has evolved into a severe psychosocial crisis affecting patients, their relatives, friends, and healthcare professionals. In Italy, public health residents (PHRs) remain essential to the national response to the pandemic. To assess their mental sphere, the "Public Mental Health" working group of the medical residents' Assembly of the Italian Society of Hygiene and Preventive Medicine has designed the Public Health Residents' Anonymous Survey in Italy (PHRASI). This is a nation-wide cross-sectional study based on an 88-item self-administered voluntary survey that evaluates how sociodemographic variables are associated with mental issues, including wellness, eating disorders, sleeplessness, alcohol misuse, depression, and anxiety. Data will be gathered by disseminating a Google Forms link across the Assembly network of medical residents. All PHRs enrolled in a four-year program in one of the Italian postgraduate schools of public health will be qualified as participants. PHRASI aims to draw a comprehensive and detailed picture of the mental health state of Italian PHRs. PHRs are a significant group of healthcare professionals that may serve as a future benchmark for developing and enacting regulations intended to support the mental health of healthcare professionals.

The Role of Gender in the Association between Mental Health and Potentially Preventable Hospitalizations: A Single-Center Retrospective Observational Study.

Psychiatric disorders and substance abuse are barriers that limit access to timely treatment and can lead to Potentially Preventable Hospitalizations (PPH). The aim of this study is to identify the role played by gender in the association between mental health and PPH. Hospital discharge records (HDRs) from the Local Health Authority of Pescara (Italy) from 2015 to 2021 were examined and PPH were measured according to Prevention Quality Indicators (PQIs) provided by the Agency for Healthcare Research and Quality. In total, 119,730 HDRs were eligible for the study and 21,217 patients fell into the PQI categories. Mental health disorders and addictions were extracted from the HDRs through the Elixhauser Enhanced ICD-9-CM algorithm. The association between PQI hospitalization and some predictors considered was evaluated with multivariate logistic regression models. In males and females, alcohol abuse showed a protective role towards preventable admissions for PQI-90 (all types of conditions) and PQI-92 (chronic conditions). In contrast, there is a gender gap in accessibility to primary health care, especially for acute conditions leading to PPH. Indeed, in males, PQI-91 admissions for acute conditions were found to be positively associated with drug abuse, psychosis, and depression, whereas this was not the case for females.

Assessing T-Cell Immunity in Kidney Transplant Recipients with Absent Antibody Production after a 3rd Dose of the mRNA-1273 Vaccine.

The vulnerable population of kidney transplant recipients (KTRs) are low responders to COVID-19 vaccines, so specific immune surveillance is needed. The interferon-gamma (IFN-γ) release assay (IGRA) is effective in assessing T cell-mediated immunity. We assessed SARS-CoV-2-directed T cell responses in KTRs with absent antibody production after a third dose of the mRNA-1273 vaccine, using two different IGRAs. A cohort of 57 KTRs, who were actively followed up, received a third dose of the mRNA-1273 vaccine. After the evaluation of humoral immunity to SARS-CoV-2, 14 seronegative patients were tested with two commercial IGRAs (SD Biosensor and Euroimmun). Out of 14 patients, one and three samples were positive by IGRAs with Euroimmun and SD Biosensor, respectively. The overall agreement between the two assays was 85.7% (κ = 0.444). In addition, multivariate linear regression analysis showed no statistically significant association between the IFN-γ concentration, and the independent variables analyzed (age, gender, years since transplant, total lymphocytes cells/mcl, CD3+ cells/mcl, CD3+ CD4+ cells/mcl, CD3+ CD8+ cells/mcl, CD19+ cells/mcl, CD3-CD16+CD56+ cells/mcl) (p > 0.01). In a vulnerable setting, assessing cellular immune response to complement the humoral response may be advantageous. Since the two commercial IGRAs showed a good agreement on negative samples, the three discordant samples highlight the need for further investigations.

Determinants of Actual COVID-19 Vaccine Uptake in a Cohort of Essential Workers: An Area-Based Longitudinal Study in the Province of Prato, Italy.

Identifying determinants of COVID-19 vaccine uptake is essential for developing effective strategies for promoting vaccination. This longitudinal study aimed to explore predictors of actual COVID-19 vaccine uptake in workers involved in essential services during the first lockdown period in the Prato Province (Italy). All essential workers were invited and surveyed before COVID-19 vaccine approval (96.5% participation rate). Participants were followed up to evaluate their actual COVID-19 vaccination uptake using the vaccination register. Multinomial models were performed to assess predictors of delayed vaccination or non-vaccination. A total of 691 participants were included, of whom 21.7% had delayed the vaccination and 4.4% were unvaccinated. Participants with a sufficient level of health literacy were 50.2% in the vaccinated-on-time group and 32.3% in the unvaccinated group. The multinomial model predictors of delayed vaccination were work type (OR = 0.51), age between 50 and 59 years (OR = 1.82), and influenza vaccination uptake in the last season (OR = 2.51). Predictors of being unvaccinated were work type (OR = 0.33) and attitudes related to attributing less importance to COVID-19 preventive measures (OR = 0.47). Findings showed distinct predictors for COVID-19 vaccination delay and for being unvaccinated. Being unvaccinated seems to be associated with a general skepticism toward prevention measures.

Vaccine hesitancy and cognitive biases: Evidence for tailored communication with parents.

Background: Vaccine hesitancy (VH) remains worldwide a reason of concern. Most of the vaccination education strategies followed a "fact-based" approach, based on the assumption that decision making is a rational process, without considering the influence of cognitive biases and heuristics. Our study aimed at identifying factors involved in the parents' vaccination choice to inform and shape communication interventions. Methods: We conducted an online national survey among parents between November 2020 and April 2021. The questionnaire consisted of 42 items organised in 4 parts: (1) personal information, (2) cognitive biases and risk propension, (3) Analytic Thinking (Cognitive Reflection Test), (4) conspiracy mentality, health literacy, and VH. Exploratory factor analysis was conducted to identify latent variables underlying the 19 items related to the 6 cognitive biases. Factors were categorised in quintiles and the corresponding pseudo-continuous variables used as predictors of the VH. Logistic regression model was applied to assess the association of the VH with factors, conspiracy mentality and risk propension. We adjusted for age, gender, economic status, and education levels. Results: The study included 939 parents, 764 women (81.4%), 69.8% had a degree or higher level of education. Considering cognitive biases, four factors explaining 54% of the total variance were identified and characterised as: fear of the side effects of vaccines (scepticism factor); carelessness of the risk and consequences of infections (denial factor); optimistic attitude (optimistic bias factor); preference for natural products (naturalness bias factor). All factors were positively associated to VH (p < 0.001) as were conspiracy mentality (p = 0.007) and risk propension (p = 0.002). Conclusions: This study confirmed the need to amplify the model used to analyse the VH considering cognitive biases as important factor affecting the parents' decision making. These results may be useful to design personalised communication interventions regarding vaccines and vaccination.

Vaccine Literacy and Source of Information about Vaccination among Staff of Nursing Homes: A Cross-Sectional Survey Conducted in Tuscany (Italy).

Vaccine literacy (VL) mediates the transfer of information and facilitates vaccination acceptance. The aims of this study are to validate the HLVa-IT (Health Literacy Vaccinale degli adulti in Italiano­Vaccine health literacy for adults in Italian language) for the staff of nursing homes (NHs), to measure VL in such a peculiar target group, and to assess its relationship with the sources used to obtain information about vaccines and vaccinations. A survey has been conducted in a sample of Tuscan NHs using an online questionnaire. Eight-hundred and fifty-three questionnaires were analyzed. Two dimensions of the HLVa-IT appeared (functional and interactive/communicative/critical VL). The HLVa-IT interactive/communicative/critical subscale score was slightly higher than the functional subscale, although with no statistical significance. General practitioners (GPs) or other professionals have been reported as the main source of information by most of the respondents (66.1%). The HLVa-IT total score was significantly higher among those who have declared to use official vaccination campaigns (mean score: 3.25 ± 0.49; p < 0.001), GPs or other health professionals (3.26 ± 0.47; p < 0.001), and search engines (3.27 ± 0.48; p = 0.040) as the main sources of information. In conclusion, the HLVa-IT could be reliable test to investigate VL for staff of NHs, and also to highlight criticalities related to information sources.

The role of neutralizing antibodies by sVNT after two doses of BNT162b2 mRNA vaccine in a cohort of Italian healthcare workers.

OBJECTIVES: Evaluating anti-SARS-CoV-2 antibody levels is a current priority to drive immunization, as well as to predict when a vaccine booster dose may be required and for which priority groups. The aim of our study was to investigate the kinetics of anti-SARS-CoV-2 Spike S1 protein IgG (anti-S1 IgG) antibodies and neutralizing antibodies (NAbs) in an Italian cohort of healthcare workers (HCWs), following the Pfizer/BNT162b2 mRNA vaccine, over a period of up to six months after the second dose. METHODS: We enrolled 57 HCWs, without clinical history of COVID-19 infection. Fluoroenzyme-immunoassay was used for the quantitative anti-S1 IgG antibodies at different time points T1 (one month), T3 (three months) and T6 (six months) following the second vaccine shot. Simultaneously, a commercial surrogate virus neutralization test (sVNT) was used for the determination of NAbs, expressed as inhibition percentage (% IH). RESULTS: Median values of anti-S1 IgG antibodies decreased from T1 (1,452 BAU/mL) to T6 (104 BAU/mL) with a percent variation of 92.8% while the sVNT showed a percent variation of 34.3% for the same time frame. The decline in anti-S1 IgG antibodies from T1 to T6 was not accompanied by a loss of the neutralizing capacity of antibodies. In fact at T6 a neutralization percentage <20% IH was observed only in 3.51% of HCWs. CONCLUSIONS: Our findings reveal that the decrease of anti-S1 IgG levels do not correspond in parallel to a decrease of NAbs over time, which highlights the necessity of using both assays to assess vaccination effectiveness.

Performance evaluation of four surrogate Virus Neutralization Tests (sVNTs) in comparison to the in vivo gold standard test.

BACKGROUND: Several commercial surrogate Virus Neutralization Tests (sVNTs) have been developed in the last year. Neutralizing anti-SARS-CoV-2 antibodies through interaction with Spike protein Receptor Binding Domain (S-RBD) can block the virus from entering and infecting host cells. However, there is a lack of information about the functional activity of SARS-CoV-2 antibodies that may be associated with protective responses. For these reasons, to counteract viral infection, the conventional virus neutralization test (VNT) is still considered the gold standard. The aim of this study was to contribute more and detailed information about sVNTs' performance, by determining in vitro the anti-SARS-CoV-2 neutralizing antibody concentration using four different commercial assays and then comparing the obtained data to VNT. METHODS: Eighty-eight samples were tested using two chemiluminescence assays (Snibe and Mindray) and two ELISA assays (Euroimmun and Diesse). The antibody titers were subsequently detected and quantified by VNT. RESULTS: The overall agreement between each sVNT and VNT was 95.45% for Euroimmun and 98.86% for Diesse, Mindray and Snibe. Additionally, we investigated whether the sVNTs were closer to the gold standard than traditional anti-SARS-CoV-2 antibody assays S-RBD or S1 based, finding a higher agreement mean value for sVNTs (98.01 ± 1.705% vs 95.45 ± 1.921%; p < 0.05). Furthermore, Spearman's statistical analysis for the correlation of sVNT versus VNT showed r = 0.666 for Mindray; r = 0.696 for Diesse; r = 0.779 for Mindray and r = 0.810 for Euroimmun. CONCLUSIONS: Our data revealed a good agreement between VNT and sVNTs. Despite the VNT still remains the gold standard, the sVNT might be a valuable tool for screening wider populations.