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Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.
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Anticuerpos Antivirales , Vacuna BNT162 , Vacunas contra la COVID-19 , COVID-19 , Huésped Inmunocomprometido , Inmunogenicidad Vacunal , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Anticuerpos Antivirales/sangre , Vacuna BNT162/inmunología , Vacuna BNT162/administración & dosificación , COVID-19/prevención & control , COVID-19/inmunología , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Inmunización Secundaria , Inmunocompetencia/inmunología , Huésped Inmunocomprometido/inmunología , Vacunas de Productos Inactivados/inmunología , Vacunas de Productos Inactivados/administración & dosificaciónRESUMEN
ABSTRACT Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.
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Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.
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Vacunas contra la COVID-19 , COVID-19 , Adulto , Anciano , Anticuerpos Antivirales , Brasil , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Femenino , Humanos , Masculino , Vacunación/efectos adversos , Vacunas de Productos Inactivados/efectos adversos , Espera VigilanteRESUMEN
INTRODUCTION: Solid organ transplant (SOT) recipients are at increased risk of Human Papillomavirus (HPV) persistent infection and disease. This study aimed to evaluate HPV seroprevalence, cervical HPV prevalence, genotype distribution, and frequency of HPV-related cervical lesions in SOT recipients in comparison to immunocompetent women. METHODS: Cross-sectional study including SOT and immunocompetent women aged 18 to 45 years who denied previous HPV-related lesions. Cervical samples were screened for HPV-DNA by a polymerase chain reaction (PCR)-based DNA microarray system (PapilloCheck®) and squamous intraepithelial lesions (SIL) by liquid-based cytology. A multiplexed pseudovirion-based serology assay (PsV-Luminex) was used to measure HPV serum antibodies. RESULTS: 125 SOT and 132 immunocompetent women were enrolled. Cervical samples were collected from 113 SOT and 127 immunocompetent women who had initiated sexual activity. HPV-DNA prevalence was higher in SOT than in immunocompetent women (29.6% vs. 20.2%, p = 0.112), but this difference was not statistically significant. High-risk (HR)-HPV was significantly more frequent in SOT than in immunocompetent women (19.4% vs. 7.9%, p = 0.014). Simultaneous infection with ≥2 HR-HPV types was found in 3.1% of SOT and 0.9% of immunocompetent women. HPV seropositivity for at least one HPV type was high in both groups: 63.8% of 105 SOT and 69.7% of 119 immunocompetent women (p = 0.524). Low-grade (LSIL) and high-grade SIL (HSIL) were significantly more frequent in SOT (9.7% and 5.3%, respectively) than in immunocompetent women (1.6% and 0.8%, respectively) (p = 0.001). CONCLUSIONS: These results may reflect the increased risk of HPV persistent infection and disease progression in SOT women due to chronic immunosuppression.
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Alphapapillomavirus/aislamiento & purificación , Cuello del Útero/patología , Infecciones por Papillomavirus/epidemiología , Displasia del Cuello del Útero/patología , Neoplasias del Cuello Uterino/patología , Adolescente , Adulto , Alphapapillomavirus/genética , Brasil , Cuello del Útero/virología , Estudios Transversales , Femenino , Genotipo , Humanos , Persona de Mediana Edad , Prevalencia , Estudios Seroepidemiológicos , Neoplasias del Cuello Uterino/virología , Adulto Joven , Displasia del Cuello del Útero/virologíaRESUMEN
Background Spiders of the genus Loxosceles are distributed throughout tropical and temperate regions worldwide. Loxosceles spp. bites may evolve to necrosis, with or without intravascular hemolysis. There is no consensus regarding the best treatment to prevent necrosis. The objective of this study was to evaluate the factors associated with the development of necrosis and the impact that antivenom administration has on the evolution of cutaneous loxoscelism. Methodology/Principal findings This was a prospective observational study carried out at a referral center for envenoming. Over a 6-year period, we included 146 patients with a presumptive or definitive diagnosis of loxoscelism. Depending on the symptom severity, a polyvalent anti-arachnid antivenom was administered or not—in 74 cases (50.7%) and 72 cases (49.3%), respectively. Cutaneous and systemic manifestations were assessed at admission and weekly thereafter. Adverse reactions to the antivenom were also evaluated. Cutaneous loxoscelism was observed in 141 cases (96.6%), and the spider was identified in 29 (19.9%). The mean time from bite to antivenom administration was 41.6 ± 27.4 h. After discharge, 130 patients (90.9%) were treated with corticosteroids, antihistamines and analgesics being prescribed as needed. The probability of developing necrosis was significantly lower among the patients who were admitted earlier, as well as among those who received antivenom (p = 0.0245). Among the 74 patients receiving antivenom, early and delayed adverse reactions occurred in seven (9.5%) and four (5.4%), respectively. Local infection was observed only in three (2.3%) of the 128 patients for whom that information was available. Conclusions/Significance Necrosis after a Loxosceles sp. bite appears to more common when hospital admission is delayed or when antivenom is not administered. In addition, the administration of a polyvalent anti-arachnid antivenom appears to be safe, with a relatively low rate of adverse reactions.
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ABSTRACT Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.
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Despite the biological relevance and abundance of non-front-fanged colubroid snakes, little is known about their medical significance. Here, we describe the clinical, epidemiological, and biological aspects of bites by two colubroid species. We retrospectively analyzed cases of Xenodon merremii and Xenodon neuwiedii bites in which the offending snake was clearly identified. Analyses included variables related to the snake and the patient, including demographic data, clinical findings, and treatments. Of the 163 cases, 123 were bites by X. merremii and 40 by X. neuwiedii. Most bites occurred in spring and summer, predominantly during the daytime. Most offending snakes were female. Bites by X. merremii juveniles were more frequent in autumn than in other seasons, whereas those by X. neuwiedii adults were in the summer. Hands and feet were the most frequently affected regions, with no significant difference between upper and lower limbs bitten by either X. merremii or X. neuwiedii. The main clinical findings were pain, transitory bleeding, erythema, and local edema. Local edema was proportionally more frequent with X. neuwiedii bites than with X. merremii bites. No patient had extensive edema or systemic envenomation. A significant association between the snout-vent-length and transitory bleeding in bites by X. merremii, but not in those by X. neuwiedii, was identified. Whole blood clotting tests were normal in all tested patients (62 cases). Sixteen patients were incorrectly treated with anti-Bothrops antivenom. In conclusion, most accidents caused by X. merremii and X. neuwiedii present mild local symptomatology. These snakes can be mistaken for lance-headed vipers, and some bites present symptoms that resemble mild bites by Bothrops sp. Physicians should be aware of X. merremii and X. neuwiedii bites to avoid unnecessary patient distress and overprescription of antivenom.
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Mordeduras de Serpientes , Adulto , Animales , Antivenenos/uso terapéutico , Brasil/epidemiología , Femenino , Humanos , Estudios Retrospectivos , Mordeduras de Serpientes/tratamiento farmacológico , Mordeduras de Serpientes/epidemiología , SerpientesRESUMEN
Despite the biological relevance and abundance of non-front-fanged colubroid snakes, little is known about the medical significance of the majority these species. Herein, we described bites by two green racer species of colubroid snakes, with respect to clinical, epidemiological, and biological features. We retrospectively analyzed proven cases of Philodryas olfersii and Philodryas aestiva bites. Only cases in which the causative animal was brought and identified by an expert were included. Analysis included variables related to the snake, patient demographics, clinical findings, whole blood clotting time (WBCT20), and treatments. Total 155 medical records were analyzed, of which 141 and 14 patients each were bitten by P. olfersii and P. aestiva, respectively. Most bites occurred in spring and summer seasons, predominantly during daytime. Most snakes were female and adult. Bites by P. olfersii adults were more frequent in summer (p < 0.001) and spring (p < 0.001). The hands were most frequently bitten by P. olfersii (59.6%), while the feet and legs (71.4%) were most bitten by P. aestiva. The most common local signs or symptoms observed were pain, edema, erythema, and transitory local bleeding. Severe pain, extensive edema, ecchymosis, and paresthesia were present only in patients bitten by P. olfersii. Significant association was observed between local bleeding and adult snakes (p = 0.019), as well as between the snout-vent-length and pain (p = 0.018), extensive edema (p = 0.024), and erythema (p = 0.047). WBCT20 was normal in the 35 cases in which it was available. Two patients were wrongly treated with anti-Bothrops antivenom. These results indicated that most accidents caused by P. olfersii and P. aestiva present mild local symptomatology. Some bites of P. olfersii bites may present local symptoms, resembling bites by Bothrops-like snakes. Physicians should be informed about these kinds of accidents, to avoid unnecessary distress to the patient and over prescription of antivenom.
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Colubridae , Mordeduras de Serpientes , Adulto , Animales , Brasil , Femenino , Humanos , Estudios Retrospectivos , Mordeduras de Serpientes/tratamiento farmacológico , Mordeduras de Serpientes/epidemiología , Venenos de SerpienteRESUMEN
This observational retrospective study conducted during an yellow fever (YF) outbreak in Sao Paulo, Brazil, in 2017-2018, describes adverse events (AE) following YF vaccination of immunocompromised persons. Risks and benefits of vaccination were individually evaluated by physicians. AE were assessed by phone call or electronic mail, 14 to 90 days after vaccination. Three hundred and eighty one immunocompromised persons received a full-dose of YF vaccine. Their age ranged from 1.4 to 89.3 years (median 50.8 years); 53% were women; 178 (46.7%) had chronic kidney disease, 78 (20.5%) had immune-mediated inflammatory diseases; 94 (24.7%) were using or had recently used immunosuppressive/ immunomodulatory drugs. All of them denied previous YF vaccination. We were able to contact 341 (89.5%) vaccinees: 233 (68.3%) of them received the YF vaccine from BioManguinhos and 108 (31.7%) received the vaccine from Sanofi-Pasteur; 130 (38.1%) vaccinees received other vaccines (up to 4) simultaneously with the the YF vaccine, mostly hepatitis B (59 vaccinees), pneumococcal polysaccharide 23-valent (46), influenza (43) and diphtheria-tetanus (dT, 41). One hundred and eleven vaccinees (32.6%) reported at least one AE: 79 (23.2%) presented systemic AE, 44 (12.9%) had local AE and 12 had both, local and systemic AE. The most common AE was pain at the injection site (41 persons, 12%), myalgia (34; 10%), fever (25; 7.3%) and headache (16; 4.7%). There was no statistically significant difference on the AE frequency according to the vaccine producer. There were four severe AE: one hospitalization and three deaths, considered not related to the YF vaccine.
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Huésped Inmunocomprometido , Vacunación/efectos adversos , Vacuna contra la Fiebre Amarilla/efectos adversos , Fiebre Amarilla/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Brasil , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Insuficiencia Renal Crónica/complicaciones , Estudios Retrospectivos , Fiebre Amarilla/epidemiología , Vacuna contra la Fiebre Amarilla/administración & dosificación , Adulto JovenRESUMEN
OBJECTIVE: We conducted a systematic review and meta-analysis to access HPV vaccines' safety and immunogenicity in Systemic Lupus Erythematosus (SLE) women. METHODS: The search was conducted in the most relevant databases. Meta-analyses to evaluate seroconversion rates for each HPV vaccine type and SLE flare rates after vaccination were performed. RESULTS: We identified 3,467 articles; six papers referring to SLE population were included. Five articles that evaluated vaccine immunogenicity at 7th month after enrollment were included in the meta-analysis. Overall seroconversion rates among SLE participants were 89.3% (95%CI, 0.76-1.00) for HPV6; 92.4% (95%CI, 0.82-1.00) for HPV11; 96.4% (95%CI, 0.93-1.00) for HPV16; and 91.8% (95%CI, 0.85-1.00) for HPV18. Five studies were included in the qualitative analysis of vaccines safety. Pain at the injection site was the most common adverse event (AE). Just one study reported serious AE not related to the vaccine. Flare rate after HPV vaccination was 12,6% (95% CI, 0.04-0.21). CONCLUSION: Few studies, small sample size, evaluated HPV vaccines in SLE women. Seroconversion rates in SLE women were like healthy women, but anti-HPV geometric mean titers (GMT) were slightly lower in SLE women. HPV vaccines were safe in this population.
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Inmunogenicidad Vacunal , Lupus Eritematoso Sistémico/inmunología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/efectos adversos , Vacunas contra Papillomavirus/inmunología , Vacunación/efectos adversos , Femenino , Humanos , Infecciones por Papillomavirus/inmunologíaRESUMEN
Despite the biological relevance and abundance of non-front-fanged colubroid snakes, little is known about their medical significance. Here, we describe the clinical, epidemiological, and biological aspects of bites by two colubroid species. We retrospectively analyzed cases of Xenodon merremii and Xenodon neuwiedii bites in which the offending snake was clearly identified. Analyses included variables related to the snake and the patient, including demographic data, clinical findings, and treatments. Of the 163 cases, 123 were bites by X. merremii and 40 by X. neuwiedii. Most bites occurred in spring and summer, predominantly during the daytime. Most offending snakes were female. Bites by X. merremii juveniles were more frequent in autumn than in other seasons, whereas those by X. neuwiedii adults were in the summer. Hands and feet were the most frequently affected regions, with no significant difference between upper and lower limbs bitten by either X. merremii or X. neuwiedii. The main clinical findings were pain, transitory bleeding, erythema, and local edema. Local edema was proportionally more frequent with X. neuwiedii bites than with X. merremii bites. No patient had extensive edema or systemic envenomation. A significant association between the snout-vent-length and transitory bleeding in bites by X. merremii, but not in those by X. neuwiedii, was identified. Whole blood clotting tests were normal in all tested patients (62 cases). Sixteen patients were incorrectly treated with anti-Bothrops antivenom. In conclusion, most accidents caused by X. merremii and X. neuwiedii present mild local symptomatology. These snakes can be mistaken for lance-headed vipers, and some bites present symptoms that resemble mild bites by Bothrops sp. Physicians should be aware of X. merremii and X. neuwiedii bites to avoid unnecessary patient distress and overprescription of antivenom.
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Despite the biological relevance and abundance of non-front-fanged colubroid snakes, little is known about the medical significance of the majority these species. Herein, we described bites by two green racer species of colubroid snakes, with respect to clinical, epidemiological, and biological features. We retrospectively analyzed proven cases of Philodryas olfersii and Philodryas aestiva bites. Only cases in which the causative animal was brought and identified by an expert were included. Analysis included variables related to the snake, patient demographics, clinical findings, whole blood clotting time (WBCT20), and treatments. Total 155 medical records were analyzed, of which 141 and 14 patients each were bitten by P. olfersii and P. aestiva, respectively. Most bites occurred in spring and summer seasons, predominantly during daytime. Most snakes were female and adult. Bites by P. olfersii adults were more frequent in summer (p < 0.001) and spring (p < 0.001). The hands were most frequently bitten by P. olfersii (59.6%), while the feet and legs (71.4%) were most bitten by P. aestiva. The most common local signs or symptoms observed were pain, edema, erythema, and transitory local bleeding. Severe pain, extensive edema, ecchymosis, and paresthesia were present only in patients bitten by P. olfersii. Significant association was observed between local bleeding and adult snakes (p = 0.019), as well as between the snout-vent-length and pain (p = 0.018), extensive edema (p = 0.024), and erythema (p = 0.047). WBCT20 was normal in the 35 cases in which it was available. Two patients were wrongly treated with anti-Bothrops antivenom. These results indicated that most accidents caused by P. olfersii and P. aestiva present mild local symptomatology. Some bites of P. olfersii bites may present local symptoms, resembling bites by Bothrops-like snakes. Physicians should be informed about these kinds of accidents, to avoid unnecessary distress to the patient and over prescription of antivenom.
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Yellow fever vaccine (YFV) is recommended in endemic areas but represents a risk for egg-allergic patients, as it is cultivated in embryonated eggs. This study aims to describe the outcomes of yellow fever vaccination in patients with confirmed egg allergy (EA). Methods:A prospective study was conducted from January 2018 to September 2019. EA was diagnosed through positive oral food challenge (OFC), recent history of anaphylaxis following egg contact (anaphylaxis in the last 6 months) or immediate allergic reaction in the last 2 months with positive specific IgE. A skinprick test (SPT) with YFV was performed. If the SPT was negative, an intradermal test (ID) was performed at a 1:100 dilution. If the ID was negative, a full dose of YFV was administered. If the skin prick test or ID were positive, the YFV was administered using a graded dosing protocol. Results: It was included 58 patients with confirmed egg allergy (36 M:22F), with a median age of 2.3 years (0.7-13.9 y/o). Forty-two patients had a positive OFC. Nine reported recent anaphylaxis. The other 7 had reactions in the last 2 months with positive specific IgE. During OFC, 15 presented anaphylaxis, while the other 27 presented hives and/or angioedema or vomiting. SPT with YFV was negative in all patients. ID was negative in 48 patients who uneventfully received a full dose of YFV. Ten patients had a positive ID and received YFV in graded doses. Six patients presented a mild reaction controlled with antihistamines, and 4 patients received the vaccine without reactions. Positive ID was significantly related to the vaccine reaction (p < 0.0001). Administration of YFV using a specific protocol was safe even in anaphylactic patients. However, we recommend performing the ID, which can help predict a higher risk of vaccine reaction. An appropriate setting is required to control adverse events.
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Hipersensibilidad al Huevo , Vacunas , Vacuna contra la Fiebre Amarilla , Fiebre Amarilla , Preescolar , Huevos , Humanos , Estudios Prospectivos , Pruebas Cutáneas , Fiebre Amarilla/prevención & control , Vacuna contra la Fiebre Amarilla/efectos adversosRESUMEN
In March 2014, the Quadrivalent human papilloma virus vaccine (4vHPV) was introduced in the female adolescents vaccination schedule of the National Immunization Program (PNI). A school-based vaccination program was implemented. We conducted a retrospective, descriptive study of the adverse events that took place after HPV vaccination, reported to the Adverse Events Following Immunization (AEFI) Information System in Sao Paulo State, from March 2014 to December 2016. All reports that fit the definitions of the 2014 National Manual on AEFI surveillance were included. AEFI risk was estimated by dividing the number of reports by the number of vaccine doses administered in the period. In the three-year period, 3,390,376 HPV vaccine doses were administered and 465 AEFI reports were registered, with 1,378 signs and symptoms. The reporting rate was 13.72 per 100,000 vaccine doses administered. The reports peaked in the first year of the program. The most frequent AEFI was syncope, with 5.7 reports per 100,000 doses administered, followed by dizziness, malaise, headache and nausea. Overall, 39 AEFI cases (8.4%) were classified as severe , with a reporting rate of 1.15 per 100,000 vaccine doses administered. Most cases were classified as severe because of hospitalization. Among them, there were cases of Guillain-Barré Syndrome, deep vein thrombosis, seizures and miscarriage. All young women recovered without sequelae. We identified five clusters of AEFI reports in four cities; the larger AEFI cluster occurred in the city of Bertioga, in September 2014, involving 13 female adolescents. Our data are in accordance with those from other countries and corroborate the safety of HPV vaccines.
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Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/efectos adversos , Adolescente , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Brasil/epidemiología , Niño , Femenino , Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11 , 16, 18/administración & dosificación , Humanos , Esquemas de Inmunización , Infecciones por Papillomavirus/prevención & control , Vigilancia de la Población , Estudios Retrospectivos , Adulto JovenRESUMEN
Abstract Introduction: Vaccination with tetanus-diphtheria-acellular pertussis (Tdap) has been recommended for healthcare workers (HCWs) by Brazilian Ministry of Health since November 2014. Objective: To describe the strategies implemented to improve Tdap uptake, cumulative vaccine coverage after each intervention, variables associated to Tdap vaccination, and reasons for non-vaccination among HCWs of the main building of a quaternary hospital attached to the Sao Paulo University Medical School. Methods: A list of HCWs eligible for pertussis vaccination was generated. From April to December 2015, the following interventions were implemented: note on intern journal reminding the importance of pertussis vaccination; email to the head nurses strengthening vaccine recommendations; lectures on pertussis and Tdap for physicians of Obstetrics and Neonatology Clinics; on-site vaccination by mobile teams at the Obstetrics, Neonatology, and Anesthesiology Clinics. Vaccine coverage was accessed at the end of each month. Multivariate Poisson regression model with a robust error variance was used to evaluate variables associated with Tdap vaccination. Reasons for non-vaccination were evaluated from January to May 2017 through phone calls for HCWs who had not received Tdap. Results: The study included 456 HCWs. After the interventions, Tdap coverage raised from 2.8% to 41.2%. In the multivariate analysis, occupation (physician), working place (obstetrics or anesthesiology) and influenza vaccination in 2015 were independently associated to Tdap vaccination. The main reason for non-vaccination was unawareness of Tdap recommendations. Conclusions: Tdap uptake among HCWs was low in our hospital. Providing vaccination at convenient places/times for HCW seems to be the most efficient strategy to increase vaccine uptake.
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Humanos , Masculino , Femenino , Adulto , Personal de Salud/estadística & datos numéricos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , Cobertura de Vacunación/métodos , Cobertura de Vacunación/estadística & datos numéricos , Hospitales Universitarios/estadística & datos numéricos , Factores de Tiempo , Brasil , Distribución de Poisson , Vigilancia de la Población , Análisis Multivariante , Lugar de Trabajo/estadística & datos numéricos , Programas de Inmunización/métodosRESUMEN
INTRODUCTION: Vaccination with tetanus-diphtheria-acellular pertussis (Tdap) has been recommended for healthcare workers (HCWs) by Brazilian Ministry of Health since November 2014. OBJECTIVE: To describe the strategies implemented to improve Tdap uptake, cumulative vaccine coverage after each intervention, variables associated to Tdap vaccination, and reasons for non-vaccination among HCWs of the main building of a quaternary hospital attached to the Sao Paulo University Medical School. METHODS: A list of HCWs eligible for pertussis vaccination was generated. From April to December 2015, the following interventions were implemented: note on intern journal reminding the importance of pertussis vaccination; email to the head nurses strengthening vaccine recommendations; lectures on pertussis and Tdap for physicians of Obstetrics and Neonatology Clinics; on-site vaccination by mobile teams at the Obstetrics, Neonatology, and Anesthesiology Clinics. Vaccine coverage was accessed at the end of each month. Multivariate Poisson regression model with a robust error variance was used to evaluate variables associated with Tdap vaccination. Reasons for non-vaccination were evaluated from January to May 2017 through phone calls for HCWs who had not received Tdap. RESULTS: The study included 456 HCWs. After the interventions, Tdap coverage raised from 2.8% to 41.2%. In the multivariate analysis, occupation (physician), working place (obstetrics or anesthesiology) and influenza vaccination in 2015 were independently associated to Tdap vaccination. The main reason for non-vaccination was unawareness of Tdap recommendations. CONCLUSIONS: Tdap uptake among HCWs was low in our hospital. Providing vaccination at convenient places/times for HCW seems to be the most efficient strategy to increase vaccine uptake.
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Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , Personal de Salud/estadística & datos numéricos , Hospitales Universitarios/estadística & datos numéricos , Cobertura de Vacunación/métodos , Cobertura de Vacunación/estadística & datos numéricos , Adulto , Brasil , Femenino , Humanos , Programas de Inmunización/métodos , Masculino , Análisis Multivariante , Distribución de Poisson , Vigilancia de la Población , Factores de Tiempo , Lugar de Trabajo/estadística & datos numéricosRESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
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Anticuerpos Antivirales/sangre , Subtipo H1N1 del Virus de la Influenza A/inmunología , Vacunas contra la Influenza/inmunología , Gripe Humana/inmunología , Adolescente , Adulto , Pruebas de Inhibición de Hemaglutinación , Humanos , Vacunas contra la Influenza/efectos adversos , Gripe Humana/prevención & control , Persona de Mediana Edad , Estudios Prospectivos , Estaciones del Año , Adulto JovenRESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
RESUMEN
Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).
RESUMEN
INTRODUCTION:: The World Health Organization (WHO) recommends one single dose of the Yellow Fever (YF) vaccine based on studies of antibody persistency in healthy adults. We assessed the prevalence and titers of YF virus neutralizing antibodies in previously vaccinated persons aged ï³ 60 years, in comparison to younger adults. We also evaluated the correlation between antibody titers and the time since vaccination among participants who received one vaccine dose, and the seropositivity among participants vaccinated prior to or within the past 10 years. METHODS:: previously vaccinated healthy persons aged ï³ 18 years were included. YF virus neutralizing antibody titers were determined by means of the 50% Plaque Reduction Neutralization Test. RESULTS:: 46 persons aged ï³ 60 years and 48 persons aged 18 to 59 years were enrolled. There was no significant difference in the prevalence of YF virus neutralizing antibodies between the two groups (p = 0.263). However, titers were significantly lower in the elderly (p = 0.022). There was no correlation between YF virus neutralizing antibody titers and the time since vaccination. There was no significant difference in seropositivity among participants vaccinated prior to or within the past 10 years. CONCLUSIONS:: the clinical relevance of the observed difference in YF virus neutralizing antibody titers between the two groups is not clear.