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Emerging variants of SARS-CoV-2 raise concerns about vaccine efficiency. Here, the authors present a post-hoc analysis for the ChAdOx1 nCoV-19 (AZD1222) vaccine trial in Brazil and provide efficacy against symptomatic COVID-19 caused by the Zeta (P.2) and other variants.

In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ). Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment. At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4–97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3–99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant. As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

Background: Vaccines in development against Group B Streptococcus (GBS) should contain the most prevalent capsular genotypes screened in the target population. In low- and middle-income countries epidemiological data on GBS carriage among pregnant women, a prerequisite condition for GBS neonatal sepsis, is needed to inform vaccine strategies. Objective: To investigate the prevalence of different GBS capsular genotypes that colonizes at-risk pregnant women in a private maternity hospital in São Paulo, Brazil. Methods: GBS strains isolated in routine maternity procedures from at-risk pregnant women from 2014 to 2018 were confirmed by mass spectrometry (MALDI-TOF) with subsequent DNA extraction for identification of capsular genotype through polymerase chain reaction (PCR). Demographic and gestational data were analyzed. Results: A total of 820 Todd-Hewitt broths positive for GBS were selected for streptococcal growth. Recovery and confirmation of GBS by MALDI-TOF were possible in 352. Strains were processed for determination of capsular genotype by PCR. From the total of 352 GBS isolates, 125 strains (35.5%) were genotyped as Ia; 23 (6.5%) as Ib; 41 (11.6%) as II; 36 (10.2%) as III; 4 (1.1%) as IV; 120 (34.1%) as V and 1 strain (0.3%) as VIII. Two isolates (0.7%) were not genotyped by used methodology. No statistically significant correlation between gestational risk factors, demographic data and distribution of capsular genotypes were found. Conclusions: GBS capsular genotypes Ia, Ib, II, III, and V were the most prevalent isolates colonizing at risk pregnant women in the present study. The inclusion of capsular genotypes Ia and V in the composition of future vaccines would cover 69.6% of capsular genotypes in the studied population. No statistically significant differences were observed between capsular genotype and gestational and demographic data and risk factors.

IntroductionActive pharmacovigilance studies are pivotal to better characterize vaccine safety.MethodsThese are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS).ResultsA total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination.ConclusionThe results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

Introduction: Immune response to vaccination in infants born prematurely may be lower than in infants born at full-term. Some clinical factors might be associated with humoral immune response. Objectives: The objectives of this study were to compare the immune response to measles and varicella vaccination in infants born prematurely with those born at full-term and to analyze factors associated with measles and varicella antibody levels. Methods: Prospective study including two groups of infants aged 12 months. One group of infants born prematurely with birth-weight

Meningococcal carriage is a prerequisite for invasive infection. This cross-sectional study assessed the pharyngeal carriage prevalence in healthy subjects aged 1–24 years in Embu das Artes city, São Paulo, Brazil. Pharyngeal swabs were examined for the presence of Neisseria meningitidis. The isolates were tested for different serogroups using agglutination and polymerase chain reaction. A logistic regression model assessed any independent association between Neisseria meningitidis carriage and various risk factors. A total of 87/967 subjects (9%, 95% Confidence Interval (CI): 7.3–11.0) tested positive for N. meningitidis: 6.2% (95% CI: 3.8–9.4) in 1–4 years, 8.5% (95% CI: 5.1–13.0) in 5–9 years, 12.5% (95% CI: 7.8–18.6) in 10–14 years, 12.6% (95% CI: 7.4–19.7) in 15–19 years and 9% (95% CI: 4.9–14.9) in 20–24 years age groups. Highest carriage prevalence was observed in adolescents 10–19 years old. Serogroup C was predominant (18.4%) followed by serogroup B (12.6%). The 15–19 years age group showed a significant association between number of household members and carriers of N. meningitidis. This cross-sectional study is the first in Brazil to evaluate meningococcal carriage prevalence and associated factors in a wide age range. Keywords: Carriage, Meningococcal disease, Neisseria meningitidis, Pharyngeal, Serogroup

OBJECTIVE:To identify the viruses involved in acute respiratory tract infections and to analyze the rates of hospitalization and death in children on palivizumab prophylaxis.METHODS: Prospective cohort of 198 infants up to one year old who were born before 29 weeks of gestational age and infants under two years old with hemodynamically unstable cardiopathy or chronic pulmonary disease who received prophylactic palivizumab against severe respiratory syncytial virus infections in 2008. During the study period, in each episode of acute respiratory tract infection, nasopharyngeal aspirate was collected to identify respiratory syncytial virus, adenovirus, parainfluenza 1, 2 and 3, influenza A and B by direct immunofluorescence, rhinovirus and metapneumovirus by polymerase chain reaction preceded by reverse transcription. Data regarding hospitalization and deaths were monitored.RESULTS: Among the 198 studied infants, 117 (59.1%) presented acute respiratory tract infections, with a total of 175 episodes. Of the 76 nasopharyngeal aspirates collected during respiratory tract infections, 37 were positive, as follow: rhinovirus (75.7%), respiratory syncytial virus (18.9%), parainfluenza (8.1%), adenovirus 2 (2.7%), metapneumovirus (2.7%) and three samples presented multiple agents. Of the 198 children, 48 (24.4%) were hospitalized: 30 (15.2%) for non-infectious etiology and 18 (9.1%) for respiratory causes. Among these 18 children, one case of respiratory syncytial virus was identified. Two deaths were reported, but respiratory syncytial virus was not identified.CONCLUSIONS: During the prophylaxis period, low frequency of respiratory syncytial virus infections and low rates of hospitalization were observed, suggesting the benefit of palivizumab prophylaxis.

The purpose of the study was to estimate the prevalence of IgG antibodies against varicella zoster virus (VZV) in the two most populated indigenous ethnic groups from Xingu Indigenous National Park, in Brazil, prior to the introduction of vaccination against the disease, and to determine the positive and the negative predictive values of a history of varicella infection. In 2001, 589 inhabitants of two Kuikuro villages and three Kaiabi villages were evaluated and provided information concerning previous varicella infection. An indirect immunosorbent assay (ELISA) to detect IgG anti-VZV antibodies was performed in 224 blood samples - volunteer selection had no interference of anamnesis. IgG prevalence was 80.8% (95% Confidence Interval: 76% - 86%). The seroepidemiology of varicella in Xingu National Park prior to varicella vaccine introduction was comparable to the Brazilian national seroprevalence described in the literature, and so were the positive (98%) and the negative predictive value (41%) of the referred history.O objetivo do estudo foi aferir a prevalência de anticorpos IgG contra o Vírus Varicela-Zoster (VVZ) nos dois grupos étnicos indígenas mais povoados do Parque Nacional Indígena do Xingu, Brasil, antes da introdução da vacinação contra a doença, e determinar os valores preditivos positivo e negativo da história de infecção de varicela. Em 2001, 589 habitantes de duas aldeias Kuikuro e três aldeias Kaiabi foram avaliados e forneceram dados referentes à infecção prévia por varicela. Um ensaio imunoenzimático indireto (ELISA) foi realizado em 224 amostras de sangue para detectar anticorpos IgG anti-VVZ - a seleção de voluntários não teve interferência da anamnese. A prevalência de IgG foi de 80,8% (Intervalo de Confiança de 95%: 76% - 86%). A soroepidemiologia de varicela no Parque Nacional do Xingu antes da introdução da vacina foi comparável à soroprevalência nacional descrita na literatura, assim como os valores preditivos positivo (98%) e negativo (41%) da história referida.

OBJETIVO: Avaliar a prevalência de anticorpos contra o vírus da hepatite A em crianças e adolescentes expostos e/ou infectados pelo HIV. MÉTODOS: Entre setembro de 1996 e agosto de 2002, foram incluídos neste estudo 352 crianças e adolescentes, filhos de mães soropositivas para o HIV (200 expostos e não-infectados pelo HIV, e 152 expostos e infectados pelo HIV). Essas crianças e adolescentes, com idade entre 1 e 14 anos, acompanhados no Ambulatório de AIDS Pediátrica da Universidade Federal de São Paulo (UNIFESP), fizeram teste sorológico contra hepatite A como parte da avaliação de rotina. A dosagem de anticorpos anti-HAV (anticorpos totais e IgM) foi realizada através do método ELISA (Dia Sorin e Radim). A comparação das faixas etárias entre os grupos foi feita utilizando o teste do qui-quadrado e, para comparar as médias de idade das categorias clínicas entre as crianças infectadas, utilizou-se o teste t. RESULTADOS: A prevalência de anticorpos contra o vírus da hepatite A foi de 34% nos pacientes infectados e expostos ao HIV e 19,7% no grupo de soro-revertidos (expostos ao HIV e não-infectados). Estratificando a amostra por faixa etária, observamos que, para as crianças de 2 a 10 anos, o grupo de infectados pelo HIV apresentou prevalência de anticorpos para o vírus hepatite A (35,5%) maior do que o grupo de soro-revertidos (16,7%) (p = 0,005). Dentro do grupo de infectados pelo HIV, estratificando a amostra em relação à categoria clínica da infecção pelo HIV, observamos que as crianças pertencentes às categorias B e C apresentaram prevalência de anticorpos para o vírus da hepatite A maior (40,5%) do que aquelas pertencentes às categorias N e A (24,1%) (p = 0,042), apesar de apresentarem média de idade sem diferença estatística: 5,66 anos para as categorias N e A e 5,18 anos para as categorias B e C (p = 0,617). CONCLUSÕES: A prevalência de anticorpos contra o vírus da hepatite A na população de crianças e adolescentes infectados e/ou expostos ao HIV na faixa etária de 1 a 14 anos foi de 26%. Considerando-se a possibilidade de agravamento da infecção pelo HIV quando associada à infecção pelo vírus da hepatite A, sugerimos a profilaxia vacinal nesse grupo de indivíduos.OBJECTIVE: To evaluate the prevalence of hepatitis A virus antibodies in HIV-exposed and/or HIV-infected children and adolescents. METHODS: Between September 1996 and August 2002, 352 patients (200 exposed, but not HIV-infected and 152 HIV exposed and infected) were included in this study. These children and adolescents (age ranged between 1 and 14 years) were all followed up at the Pediatric AIDS Clinic of the Federal University of São Paulo (UNIFESP) and had anti-HAV antibodies determined by a commercially available ELISA method (tests for total anti-HAV antibodies and specific IgM antibodies) (Dia Sorin and Radim). Statistical analyses were done with chi-squared and t test. RESULTS: The prevalence of hepatitis A virus antibodies in HIV-infected and HIV-exposed, but uninfected patients was 34% and 19.7%, respectively. We noticed that in the age range between 2 years and 10 years, the group of HIV-infected children presented a higher prevalence of hepatitis A virus antibodies (35.5%) than the group of uninfected children (16.7%) (p = 0.005). In the HIV infected group, children from B and C categories had a prevalence of hepatitis A virus antibodies (40.5%) higher than N and A categories (24.1%) (p = 0.042). Mean age did not differ when children from B and C categories were compared with N and A categories (5.18 and 5.66 years, respectively) (p = 0.617). CONCLUSIONS: The prevalence of hepatitis A virus antibodies in HIV exposed and/or infected children and adolescents between 1 and 14 years old was 26%. Considering the possibility of HIV infection aggravation when associated with hepatitis A virus infection, we suggest that hepatitis A virus inactivated vaccine should be administered to these patients.

We have developed a cheaper an simple in house indirect ELISA that uses the live attenuated VZV vaccine as a coating antigen. The alternative ELISA had an agreement of 94% when compared with a commercial VZV ELISA kit. Moreover, our ELISA proved to be more reliable than the kit when assessing true negative samples. By adding a standard serum, we were able to produce results in international units per millilitre. Also, the addition of an extra step with 8M urea allowed the assessment of VZV IgG avidity without excessive costs. The cost per sample to test VZV IgG was 2.7 times cheaper with our ELISA, allowing the testing of many samples without the burden of production of VZV antigen in the laboratory.Desenvolvemos um ensaio imunoenzimático (ELISA) indireto simples e econômico para detecção de anticorpos contra o vírus da varicela zoster (VVZ) que utiliza a vacina contendo o vírus vivo atenuado como antígeno para recobrir a placa. Este ELISA mostrou uma concordância de 94% quando comparado com um kit de ELISA comercial para anticorpos contra varicela. Além disso, nosso ELISA mostrou ser mais confiável que o kit quando amostras comprovadamente negativas foram testadas. O uso de um soro padrão de referência, calibrado em unidades internacionais por mililitro, possibilitou também que os resultados pudessem ser comparados com outros estudos. O acréscimo de uma etapa extra com solução de uréia 8M permitiu avaliação de avidez de IgG para VVZ sem custos excessivos. O custo por amostra para testar IgG contra VVZ com nosso ELISA foi 2,7 vezes mais barato quando comparado com o kit comercial.

A seroprevalence study to detect total antibodies against Hepatitis A Virus was done with 220 samples from 589 Native Indians from Xingu National Park, Brazil, in five Kaiabi and Kuikuro villages, the most populous ethnic groups. Using a commercial immunoassay kit we detected 97.7% positive samples (95% Confidence Interval: 95%-99%). We noticed a precocious seroconversion, before the age of six years, when the disease is usually asymptomatic. These results are similar to those found in the literature in non-Indian population studies of the Northern, Northeastern and West Central regions of Brazil. They suggest that it is not necessary to introduce vaccination against Hepatitis A in these highly endemic populations.Um estudo de soroprevalência para detectar anticorpos totais contra o Vírus da Hepatite A foi realizado com 220 amostras obtidas de 589 indivíduos de cinco aldeias indígenas das tribos Kaiabi e Kuikuro, as mais populosas do Parque Nacional do Xingu, Brasil. Utilisando um kit comercial de ensaio imunoenzimático, detectamos 97,7% amostras positivas (Intervalo de Confiança de 95%: 95%-99%), com uma soroconversão precoce, antes dos seis anos de idade, quando a doença costuma ser assintomática. Estes resultados são semelhantes aos resultados encontrados na literatura em estudos com populações não-indígenas das regiões Norte, Nordeste e Centro-Oeste do Brasil, e sugere que não há necessidade de introdução de vacinação contra Hepatite A nestas populações de alta endemicidade.

OBJETIVOS: Apresentar uma atualização da situação da poliomielite no mundo, número de casos anuais, regiões mais atingidas pela doença, vacinas disponíveis na atualidade, seus riscos e benefícios, utilização da vacina monovalente, riscos da disseminação de um vírus mutante na comunidade, progressos que têm sido realizados em termos de erradicação mundial e as propostas da Organização Mundial da Saúde (OMS) nesse período de transição entre a erradicação global e o período pós-erradicação. FONTE DE DADOS: Foram consultadas bases de dados no período de 1955 a 2005 em MEDLINE, LILACS, The Web, Doctor's Guide; site da OMS e Organização Pan-Americana da Saúde (OPAS) e livro-texto. SÍNTESE DOS DADOS: Em 1988, a OMS estabeleceu como meta a erradicação da doença e a interrupção da transmissão do vírus selvagem globalmente. Desde então, houve um dramático impacto no declínio da doença, embora em 2005 ainda existam alguns países considerados endêmicos e outros onde a pólio retornou, por conta de vírus importados. As vacinas utilizadas no mundo são as clássicas tOPV e IPV e, dentro desse processo de erradicação, o uso de vacinas mOPV tem sido estimulado nos locais em que circula apenas um tipo de poliovírus. Entretanto, as vacinas OPV, além de disseminarem o vírus na comunidade, podem causar paralisias por reversão do processo de neurovirulência. CONCLUSÕES:Para um mundo livre da doença poliomielite, será preciso retirar o vírus de circulação, o que só será possível se a vacina OPV for descontinuada, conforme propostas da OMS para esse período de transição e para a era pós-erradicação.OBJECTIVES: To present an update on the status of poliomyelitis worldwide, number of cases per year, regions most affected by the disease, vaccines currently available, their risks and benefits, monovalent vaccine use, risks of disseminating a mutant virus in the community, progress that has been made in terms of worldwide eradication and the World Health Organization.s (WHO) proposals in this transition period between global eradication and the post-eradication period. SOURCES OF DATA: Data for the period from 1955 to 2005 were searched in MEDLINE, LILACS, The Web, Doctor's Guide, WHO website and Pan American Health Organization (PAHO) website and text book. SUMMARY OF THE FINDINGS: In 1988, the WHO established the goal of eradicating the disease and interrupting transmission of the wild virus globally. Since then, there has been a dramatic decline of the disease, although in 2005 there were still some countries considered endemic and others where polio returned on account of imported viruses. The vaccines used worldwide are the classical tOPV and IPV, and in this eradication process, the use of mOPV vaccines has been encouraged in places where only one type of poliovirus circulates. In addition to spreading the virus in the community, the OPV vaccines may, however, cause paralyses by reversal of the neurovirulence process. CONCLUSIONS: For a world free of poliomyelitis disease, it would be necessary to interrupt circulation of the virus, which will only be possible if the OPV virus were to be discontinued, in accordance with the WHO proposals for this transition period and the post-eradication period.

SUMMARY BCG adverse events (BCG-AE) are rare conditions with no well-established treatment. This study aims to describe clinical characteristics and outcome of localized BCG-AE. Children with BCG-AEs who were treated at the Reference Center for Special Immunobiologicals of the Federal University of São Paulo from 2009 to 2011 were included. Patients were followed monthly until 3 months after healing. One hundred and twenty-seven patients with localized BCG-AE were followed: 67 (52.7%) had suppurative lymphadenitis; 30 (23.6%) injection-site abscess; five (3.9%) had enlarged lymph node > 3 cm; four (3.1%) had ulcer > 1 cm; and one (0.8%) had a local bacterial infection. Five patients (3.9%) had more than one BCG-AE simultaneously. Fifteen patients (11.8%) had atypical manifestations: seven wart-like lesions; five BCG reactivations; two other dermatologic lesions and one with vasomotor phenomenon. Isoniazid was used in 96 patients with typical BCG-AE (85.7%) until lesion resolution which took place 3.1 months later (in median); the healing rate was 90.6%. Patients with atypical manifestations had an individual approach. Regarding the outcome, 105/112 patients with typical AE and 13/15 patients with atypical AE had resolution of BCG-AE. Localized BCG-AE caused by BCG Moreau RJ had positive outcome when treated with a short course of isoniazid. Atypical BCG-AE are not infrequent.