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Importance: COVID-19 and seasonal influenza vaccines were previously given separately, although their coadministration is warranted for vaccination adherence. Limited data on their coadministration have been published. Objective: To compare the reactogenicity and immunogenicity of COVID-19 and influenza vaccinations administered together with those of COVID-19 vaccination alone. Design, Setting, and Participants: This prospective cohort study included health care workers at a large tertiary medical center in Israel who received the Influvac Tetra (Abbott) influenza vaccine (2022/2023), the Omicron BA.4/BA.5-adapted bivalent (Pfizer/BioNTech) vaccine, or both. Vaccination began in September 2022, and data were collected until January 2023. Vaccines were offered to all employees and were coadministered or given separately. Adverse reaction questionnaires were sent, and serologic samples were also collected. Exposures: Receiving COVID-19 vaccine, influenza vaccine, or both. Main Outcomes and Measures: The main outcomes for the reactogenicity analysis were symptoms following vaccine receipt, assessed by a digital questionnaire: any local symptoms; fever; weakness or fatigue; any systemic symptoms; and their duration. The immunogenicity analysis' outcome was postvaccination anti-spike IgG titer. Results: This study included 2 cohorts for 2 separate analyses. The reactogenicity analysis included 588 participants (of 649 questionnaire responders): 85 in the COVID-19 vaccine-alone group (median [IQR] age, 71 [58-74] years; 56 [66%] female); 357 in the influenza vaccine-alone group (median [IQR] age, 55 [40-65] years; 282 [79%] female); and 146 in the coadministration group (median [IQR] age, 61 [50-71] years; 81 [55%] female). The immunogenicity analysis included 151 participants: 74 participants in the COVID-19 vaccine group (median [IQR] age, 67 [56-73] years; 45 [61%] female) and 77 participants in the coadministration group (median [IQR] age, 60 [49-73] years; 42 [55%] female). Compared with COVID-19 vaccination alone, the risk of systemic symptoms was similar in the coadministration group (odds ratio, 0.82; 95% CI, 0.43-1.56). Geometric mean titers in the coadministration group were estimated to be 0.84 (95% CI, 0.69-1.04) times lower than in the COVID-19 vaccine-alone group. Conclusions and Relevance: In this cohort study of health care workers who received a COVID-19 vaccine, an influenza vaccine, or both, coadministration was not associated with substantially inferior immune response or to more frequent adverse events compared with COVID-19 vaccine administration alone, supporting the coadministration of these vaccines.
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COVID-19 , Vacunas contra la Influenza , Femenino , Humanos , Anciano , Persona de Mediana Edad , Masculino , COVID-19/prevención & control , Vacunas contra la Influenza/efectos adversos , Vacunas contra la COVID-19/efectos adversos , Estudios de Cohortes , Estudios ProspectivosRESUMEN
To study the differences in the immune response to SARS-CoV-2 infection compared to the response to vaccination, we characterized the humoral immune kinetics of these situations. In this prospective longitudinal study, we followed unvaccinated COVID-19-recovered individuals (n = 130) and naïve, two-dose BNT162b2-vaccinated individuals (n = 372) who were age- and BMI-matched for six months during the first pandemic year. Anti-RBD-IgG, neutralizing antibodies (NAbs), and avidity were assessed monthly. For recovered patients, data on symptoms and the severity of the disease were collected. Anti-RBD-IgG and NAbs titers at peak were higher after vaccination vs. after infection, but the decline was steeper (peak log IgG: 3.08 vs. 1.81, peak log NAbs: 5.93 vs. 5.04, slopes: -0.54 vs. -0.26). Peak anti-RBD-IgG and NAbs were higher in recovered individuals with BMI > 30 and in older individuals compared to individuals with BMI < 30, younger population. Of the recovered, 42 (36%) experienced long-COVID symptoms. Avidity was initially higher in vaccinated individuals compared with recovered individuals, though with time, it increased in recovered individuals but not among vaccinated individuals. Here, we show that while the initial antibody titers, neutralization, and avidity are lower in SARS-CoV-2-recovered individuals, they persist for a longer duration. These results suggest differential protection against COVID-19 in recovered-unvaccinated vs. naïve-vaccinated individuals.
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Importance: A correlation between antibody levels and risk of infection has been demonstrated for the wild-type, Alpha, and Delta SARS-COV-2 variants. High rates of breakthrough infections by the Omicron variant emphasized the need to investigate whether the humoral response elicited by mRNA vaccines is also associated with reduced risk of Omicron infection and disease. Objective: To investigate whether the high antibody levels in individuals who have received at least 3 doses of an mRNA vaccine are associated with reduced risk of Omicron infection and disease. Design, Setting, and Participants: This prospective cohort study used serial real time-polymerase chain reaction (RT-PCR) and serological test data from January and May 2022 to assess the association of preinfection immunoglobin G (IgG) and neutralizing antibody titers with incidence of Omicron variant infection, incidence of symptomatic disease, and infectivity. Participants included health care workers who had received 3 or 4 doses of an mRNA COVID-19 vaccine. Data were analyzed from May to August 2022. Exposures: Levels of SARS-CoV-2 anti-receptor binding domain IgG and neutralizing antibodies. Main Outcomes and Measures: The main outcomes were incidence of Omicron infection, incidence of symptomatic disease, and infectivity. Outcomes were measured using SARS-COV-2 PCR and antigen testing and daily online surveys regarding symptomatic disease. Results: This study included 3 cohorts for 3 different analyses: 2310 participants were included in the protection from infection analysis (4689 exposure events; median [IQR] age, 50 [40-60] years; 3590 [76.6%] among female health care workers), 667 participants (median [IQR] age, 46.28 (37.44,54.8); 516 [77.4%] female) in the symptomatic disease analysis, and 532 participants (median [IQR] age, 48 [39-56] years; 403 [75.8%] female) in the infectivity analysis. Lower odds of infection were observed for each 10-fold increase in preinfection IgG (odds ratio [OR], 0.71; 95% CI, 0.56-0.90) and for each 2-fold increase in neutralizing antibody titers (OR, 0.89; 95% CI, 0.83-0.95). The odds of substantial symptomatic disease were reduced for each 10-fold increase in IgG levels (OR, 0.48; 95% CI, 0.29-0.78) and for each 2-fold increase in neutralizing antibodies levels (OR, 0.86; 95% CI, 0.76-0.96). Infectivity, assessed by mean cycle threshold value, was not significantly decreased with increasing IgG or neutralizing antibodies titers. Conclusions and Relevance: In this cohort study of vaccinated health care workers, IgG and neutralizing antibody titer levels were associated with protection against infection with the Omicron variant and against symptomatic disease.
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COVID-19 , Humanos , Femenino , Persona de Mediana Edad , Masculino , Israel , Vacunas contra la COVID-19 , Estudios de Cohortes , Estudios Prospectivos , SARS-CoV-2 , Anticuerpos Neutralizantes , Personal de Salud , Inmunoglobulina GRESUMEN
OBJECTIVES: The capability of the SARS-CoV-2 Omicron variant to escape immunity conferred by mRNA vaccines has led to the development of Omicron-adapted vaccines. In this study, we aimed to compare the immune response with the ancestral strain and with the BA.1 Omicron variant after administration of the original vaccine and the Omicron-adapted vaccine. METHODS: This is an ongoing phase 3, double-blinded randomized controlled trial, comparing the original BNT161b2 vaccine, monovalent Omicron BA.1-adapted BNT161b2 vaccine, and bivalent combinations. Each vaccine was given at a 30 µg and 60 µg dose. Primary outcomes considered included neutralization titers of SARS-CoV-2 ancestral strain and Omicron BA.1. Exploratory endpoints included neutralization titers for Omicron BA.5, and the incidence of COVID-19 cases. RESULTS: Overall, 122 individuals (22, 19, 20, 20, 20, 20, and 21 in each arm) completed a 90-day follow-up. Three months after vaccination, adjusting for baseline levels, neutralizing antibody titers were 0.63 (95% CI: 0.3-1.32) and 0.54 (0.24-1.2) for monovalent/60 µg, 0.9 (0.42-1.92) and 2.69 (1.17-6.17) times for monovalent-Omi.BA.1/30 µg, 1.28 (0.6-2.75) and 2.79 (1.21-6.41) times for monovalent-Omi.BA.1/60 µg, 0.96 (0.46-1.97) and 2.07 (0.93-4.58) times for bivalent-Omi.BA.1/30 µg, and 0.79 (0.38-1.63) and 1.95 (0.88-4.32) times for bivalent-Omi.BA.1/60 µg when compared with BNT162b2/30 µg against the ancestral strain and BA.1 variant, respectively. DISCUSSION: BA.1-adapted mRNA vaccines lead to a stronger neutralizing antibody response against the Omicron BA.1 sub-variant.
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COVID-19 , Vacunas , Humanos , Vacuna BNT162 , Estudios de Seguimiento , COVID-19/prevención & control , SARS-CoV-2/genética , Vacunas de ARNm , Anticuerpos Neutralizantes , Anticuerpos AntiviralesRESUMEN
BACKGROUND: Identifying COVID-19 correlates of protection and immunity thresholds is important for policy makers and vaccine development. We aimed to identify correlates of protection of BNT162b2 (Pfizer-BioNTech) vaccination against COVID-19. METHODS: In this prospective cohort study, households within a radius of 40 km of the Sheba Medical Center in Israel in which a new SARS-CoV-2 infection (defined as the index case) was detected within the previous 24 h were approached between July 25 and Nov 15, 2021. We included adults (aged >18 years) who had received one or two vaccine doses, had an initial negative SARS-CoV-2 PCR and no previous infection reported, and had a valid IgG and neutralising antibody result. The exposure of interest was baseline immune status, including IgG antibody concentration, neutralising antibody titre, and T-cell activation. The outcomes of interest were PCR-positive SARS-CoV-2 infection between day 2 and day 21 of follow-up and intensity of disease symptoms (self-reported via a telephone questionnaire) among participants who had a confirmed infection. Multivariable logistic and ordered logit ordinal regressions were used for the adjusted analysis. To identify immunological thresholds for clinical protection, we estimated the conditional probability of infection and moderate or severe disease for individuals with pre-exposure IgG and neutralising antibody concentrations above each value observed in the study data. FINDINGS: From 16 675 detected index cases in the study region, 5718 household members agreed to participate, 1461 of whom were eligible to be included in our study. 333 (22·8%) of 1461 household members who were not infected with SARS-CoV-2 at baseline were infected within 21 days of follow-up. The baseline (pre-exposure) IgG and neutralising antibodies were higher in participants who remained uninfected than in those who became infected (geometric mean IgG antibody concentration 168·2 binding antibody units [BAU] per mL [95% CI 158·3-178·7] vs 130·5 BAU/mL [118·3-143·8] and geometric mean neutralising antibody titre 197·5 [181·9-214·4] vs 136 ·7 [120·3-155·4]). Increasing IgG and neutralising antibody concentrations were also significantly associated with a reduced probability of increasing disease severity. Odds of infection were significantly reduced each time baseline IgG antibody concentration increased by a factor of ten (odds ratio [OR] 0·43 [95% CI 0·26-0·70]) and each time baseline neutralising antibody titre increased by a factor of two (0·82 [0·74-0·92]). In our cohort, the probability of infection if IgG antibody concentrations were higher than 500 BAU/mL was 11% and the probability of moderate disease severity was 1%; the probability of infection if neutralising antibody titres were above or equal to 1024 was 8% and the probability of moderate disease severity was 2%. T-cell activation rates were not significantly associated with reduced probability of infection (OR 1·04, 95% CI 0·83-1·30). INTERPRETATION: Both IgG and neutralising antibodies are correlates of protection against SARS-CoV-2 infection. Our data suggest that IgG concentrations higher than 500 BAU/mL and neutralising antibody titres of 1024 or more are thresholds for immunological protection from SARS-CoV-2 delta variant infection. Potentially, updated protective thresholds against emerging variants of concern could be calculated, which could support decision makers on administration of new vaccination strategies and on the optimal period between vaccine doses. FUNDING: Israeli Ministry of Health.
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COVID-19 , SARS-CoV-2 , Adulto , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Israel/epidemiología , Vacuna BNT162 , Estudios Prospectivos , Anticuerpos Neutralizantes , Inmunoglobulina GRESUMEN
Background: Endometriosis is a chronic inflammatory disease that has a significant negative impact on the lives of women, causing them pain, anxiety, depression, and a decreased quality of life (QoL). Studies have shown that the practice of yoga with provide relief from lower back pain, menopausal symptoms, stress, and depression. Further, they indicate that it may ameliorate the effects of endometriosis. Objective: The study aimed to examine the effect of practicing endometriosis yoga on the stress and QoL of women diagnosed with endometriosis. Design: This was an AB design study which included 52 women diagnosed with endometriosis. Setting: The research was conducted twice a week online. Participants: Forty-two (42) women participated in the study and were included in the analysis. Interventions: The program included eight weeks of conventional therapy, followed by eight weeks of 90-minute endometriosis yoga classes held twice a week. The women served as their own control group. Their symptoms were assessed at three time points: prior to two months of conservative treatment, after two months of conservative treatment, and following two months of the conservative treatment and yoga intervention. The outcome measures were the Endometriosis Health Profile (EHP-30), a numerical pain rating scale (NPRS), and intensity of bleeding during the last menstrual period. Results: All outcome measures improved after the women completed the endometriosis yoga intervention. The EHP-30 and NPRS questionnaire scores were lower after the intervention program (P = .001) as was the blood-flow intensity (P = .019). Conclusions: The practice of endometriosis yoga is recommended for women with endometriosis to reduce levels of pain and stress and to improve QoL.
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Endometriosis , Yoga , Femenino , Humanos , Calidad de Vida , Endometriosis/terapia , Proyectos Piloto , DolorRESUMEN
BACKGROUND: COVID-19 restrictions have led to social isolation affecting youth's health, particularly at-risk youth. OBJECTIVES: We examined whether an online mentoring health intervention (OMHI) would strengthen characteristics that can prevent risky behaviors: resilience, perceived social support, psychological distress, and crisis concerns. METHODS: Fifty-six secondary-school students participated, 27 in the intervention group and 29 in the control group (mean age 16.18, SD 0.83 vs. 16.62, SD 0.82, respectively). The study took place between March and August 2020. RESULTS: The intervention group was less resilient pre-test, with similar resilience levels as the control group post-test. Intervention group participants presented a significantly higher crisis level pre- and post-test than the control group, as well as an increase in resilience (effect size = 1.88) and social support (effect size = 1.22), while psychological distress significantly decreased (effect size = -1.03). Both groups (intervention vs. control) predicted changes from pre-to-post test for resilience and crisis (adjusted R2 = 0.33, p = 0.001 and R2 = 0.49, p = 0.0001 respectively). CONCLUSIONS: OMHI participation was associated with improved resilience and social support, and decreased psychological distress, making it an effective strategy in health promotion for at-risk youth. An online intervention program combining mentoring in physical activity and interpersonal connections may constitute an effective health promotion strategy for at-risk youth, especially in times of crisis.
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There are limited data concerning the immunogenicity and reactogenicity of COVID-19 vaccines in children. A total of 110 children, 5-11 years old were vaccinated with two doses (with a 3-week interval between doses) of the Pfizer-BioNTech COVID-19 vaccine and were followed for 21, 90, and 180 days after vaccination for immunogenicity, adverse events, and breakthrough infections. Ninety days after the first vaccine dose, the GeoMean (CI 95%) of IgG ascended to 1291.0 BAU (929.6-1790.2) for uninfected children and 1670.0 BAU (1131.0-2466.0) for Infected children. One hundred and eighty days after receiving the first dose of the vaccine, the titers decreased to 535.5 BAU (288.4-993.6) for the uninfected children, while only a small decline was detected among infected children-1479.0 (878.2-2490.0). The neutralizing antibodies titer almost did not change over time in the uninfected children, and even elevated for the infected children. Of the 110 vaccinated children, 75.5% were infected, with only mild COVID-19 infection symptoms. Child vaccination was found to be safe, with mild, mostly local, and of short duration, reported AEs. No serious adverse events (SAEs) were reported after vaccination. The durability of two doses of vaccine in children is longer, thus a booster may not be needed as early as in adults.
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BACKGROUND: The COVID-19 pandemic has been spreading consistently since the beginning of 2020. On February 27, 2020, the first patient with coronavirus was diagnosed in Israel. On March 14, 2020, the Israeli government declared a general lockdown that lasted about a month, which altered the lives of the entire population. OBJECTIVE: The objective of this paper is to evaluate the change in the well-being, physical activity, and sleep quality of undergraduate students of education at 2 time points: before (November 2019) and during (April 2020) the first COVID-19 lockdown. METHODS: In total, 533 undergraduate students of education submitted an online questionnaire before the lockdown and at its end. The questionnaire comprised 4 parts: a (1) sociodemographic and (2) weekly exercise questionnaire taken from the International Physical Activity Questionnaire-Short Form; (3) sleep quality, rated using the Mini Sleep Questionnaire; and (4) well-being, rated using the short version of the Mental Health Inventory. This was a pre-post prospective cohort questionnaire study. RESULTS: It was predicted that there would be a decrease in the aforementioned parameters. Contrary to all expectations, an increase was observed in all 3. Results showed that during the lockdown, there was an increase in the level of exercise students engaged in. Overall, 102 (61.4%) of 166 students engaged in a greater amount of physical activity during the COVID-19 lockdown compared to 150 (40.9%) of 367 students who engaged in a greater amount of physical activity before COVID-19. Levels of sleep quality (mean 5.34 [SD 0.92] vs mean 5.12 [SD 0.46], P=.02) and well-being (mean 3.79 [SD 0.62] vs mean 3.67 [SD 0.59], P=.02) were also higher during the COVID-19 lockdown. CONCLUSIONS: These findings indicate that undergraduate students seem to have taken advantage of the change in lifestyle due to the lockdown, directing the free time toward improving health by engaging in more physical activity, thus improving sleep quality and well-being.
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BACKGROUND: Obesity is an independent risk factor for many diseases. Many studies have investigated the benefits of losing weight as well as the best methods for weight loss. This research evaluated the impact of various weight loss programs on health enhancement among overweight women aged 40-60 years. METHODS: This was a retrospective observational study that analyzed data from 145 overweight women in weight loss programs. Each woman joined one of four programs: 8 weeks of exercise plus diet (exe + nutr), 8 weeks of diet only (nutrition), 8 weeks of exercise only, or a control group. Women completed a psychological questionnaire and also underwent anthropometric tests, blood pressure checks, a predicted maximal oxygen consumption (VO2 max) test on an ergometer bicycle, a one-leg balance test, straight leg test, and a sit and reach test, both before and after the program. Participants also provided a blood sample. RESULTS: All of the measured variables improved in the exe + nutr and nutrition programs when compared with the control group; the exe + nutr group improved the most: body mass index, -1.3 kg/m2; body fat, -2.9%; lean body mass, +1.1; VO2 max, +4.8; body image, +1.02; and p < 0.01. CONCLUSION: The hypothesis-generating findings showed that weight loss programs improved anthropometric, biochemical, physiological, physical, and psychological variables in women aged 40-60 years. The program that included diet restriction with exercise, guidance, and regular counseling showed the best results.
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Dieta Reductora , Ejercicio Físico/fisiología , Obesidad/fisiopatología , Sobrepeso/fisiopatología , Pérdida de Peso/fisiología , Programas de Reducción de Peso/normas , Adulto , Índice de Masa Corporal , Femenino , Humanos , Israel , Persona de Mediana Edad , Obesidad/dietoterapia , Sobrepeso/dietoterapia , Estudios RetrospectivosRESUMEN
Viruses cause a variety of illnesses in humans, yet only a few antiviral drugs have been developed; thus, new antiviral drugs are urgently needed. Plants could be a good source of antiviral drugs, they do not have mobility and can only defend themselves by producing compounds against pathogens such as viruses in their own fix environment. These compounds may have the potential to inhibit animal and human viruses as well. In this study, a fast and reliable method for screening plant extracts for specific antiviral activity against Herpes simplex virus type-1 (HSV-1) was developed. This method distinguishes between host cell death due to infectivity and multiplicity of the virus versus toxicity of the plant extract. Extracts from 80 plant and plant organs were screened using this approach. Six plant extracts showed potential to exert specific HSV-1 growth inhibition activity. In two cases, different organs from the same plant showed similar active results. With this method it is possible to screen a large number of extracts in a rapid and accurate way to detect antiviral substances against HSV-I and other viruses.
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Antivirales/aislamiento & purificación , Evaluación Preclínica de Medicamentos/métodos , Herpesvirus Humano 1/efectos de los fármacos , Extractos Vegetales/aislamiento & purificación , Animales , Antivirales/farmacología , Antivirales/toxicidad , Supervivencia Celular/efectos de los fármacos , Chlorocebus aethiops , Herpesvirus Humano 1/fisiología , Ensayos Analíticos de Alto Rendimiento/métodos , Extractos Vegetales/farmacología , Extractos Vegetales/toxicidad , Células Vero , Replicación Viral/efectos de los fármacosRESUMEN
BACKGROUND: Cell migration, angiogenesis, inflammation, and extracellular matrix remodeling are key events in wound healing. Natural products, including fatty acids (FAs), can accelerate wound healing by modulating the aforementioned events. AIMS: This study aims to evaluate the effect of lucuma (Pouteria lucuma O Kezte) nut oil (LNO) on fibroblasts migration, angiogenesis, inflammation, bacterial and fungal growth, and wound healing. Methods GC-MS analysis of FAs methyl esters (FAMES) was used for chemical characterization of LNO. In vitro studies were carried out with LNO investigating the induction of cell migration, cytoskeleton remodeling of human fibroblasts, inhibition of LPS-induced nitric oxide production in macrophages, and antibacterial and antifungal effects. Two in vivo studies were carried out to study LNO's effect on angiogenesis and wound healing: (i) tail fin regeneration in transgenic zebrafish larvae expressing enhanced green fluorescent protein (EGFP) in vascular endothelial cells was used to study vessel sprouting and wound healing and (ii) the closure of wounds was evaluated in CD-1 mice after topical applications of LNO-containing formulations. RESULTS: Lucuma nut oil is a mixture of FAs, 99.7% of which were characterized. Major components of LNO (w/w) are linoleic acid (38.9%), oleic acid (27.9%), palmitic acid (18.6%), stearic acid (8.9%), and γ linolenic acid (2.9%). In vitro studies showed that LNO significantly promoted migration and vinculin expression in human fibroblasts. LNO decreased LPS-induced nitric oxide production and did not display significant antibacterial or antifungal effects. LNO induced tail fin regeneration in transgenic zebrafish larvae 48 h after tail fin amputation and significantly accelerated cutaneous wound closure in CD-1 mice. CONCLUSIONS: Natural FAs from P. lucuma nut promote skin regeneration and, thus, may have applications in medicine and skin care.
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Aceites de Plantas/uso terapéutico , Piel/efectos de los fármacos , Cicatrización de Heridas/efectos de los fármacos , Animales , Animales Modificados Genéticamente , Movimiento Celular/efectos de los fármacos , Movimiento Celular/fisiología , Fibroblastos/efectos de los fármacos , Fibroblastos/fisiología , Cromatografía de Gases y Espectrometría de Masas , Humanos , Recién Nacido , Macrófagos/efectos de los fármacos , Macrófagos/fisiología , Ratones , Aceites de Plantas/química , Pouteria , Fenómenos Fisiológicos de la Piel , Pez Cebra/genéticaRESUMEN
BACKGROUND: Guidelines issued by the WHO call for immunization against yellow fever (YF) at least 10 days before entering an endemic area. We assessed the extent at which travelers complied with these guidelines. METHODS: A two-phase study at one travel center in Israel. Phase I-travelers planning to visit YF-endemic areas (n = 295) were evaluated in regard to the timing of administration of YF vaccine before travel. Phase II-the specific causes of arriving late were studied prospectively in another group of 132 travelers. RESULTS: Phase I-one-half of the travelers (n = 148) headed to South America (SA), and 147 to Africa. The mean age (+/-SD) of this cohort was 30.9 (+/-14.9) years (range 6-75 years). Overall, 64 (21.7%; 95% confidence interval, 17.4-26.8) received the vaccine less then 10 days before departure. However, only 10.8% of those heading to SA arrived late, as compared to 32.7% of those heading to Africa (p < 0.0001). Phase II-a last minute's decision was the commonest reason given for arriving late (43.2%). CONCLUSION: One-fifth of travelers fail to comply with the WHO guidelines concerning YF vaccination. Travelers and travel agents alike need to be reminded of the importance of timely vaccination against YF.