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1.
Vaccine ; 37(38): 5796-5802, 2019 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-30497831

RESUMO

Live viral vectors that express heterologous antigens of the target pathogen are being investigated in the development of novel vaccines against serious infectious agents like HIV and Ebola. As some live recombinant vectored vaccines may be replication-competent, a key challenge is defining the length of time for monitoring potential adverse events following immunization (AEFI) in clinical trials and epidemiologic studies. This time period must be chosen with care and based on considerations of pre-clinical and clinical trials data, biological plausibility and practical feasibility. The available options include: (1) adapting from the current relevant regulatory guidelines; (2) convening a panel of experts to review the evidence from a systematic literature search to narrow down a list of likely potential or known AEFI and establish the optimal risk window(s); and (3) conducting "near real-time" prospective monitoring for unknown clustering's of AEFI in validated large linked vaccine safety databases using Rapid Cycle Analysis for pre-specified adverse events of special interest (AESI) and Treescan to identify previously unsuspected outcomes. The risk window established by any of these options could be used along with (4) establishing a registry of clinically validated pre-specified AESI to include in case-control studies. Depending on the infrastructure, human resources and databases available in different countries, the appropriate option or combination of options can be determined by regulatory agencies and investigators.

3.
Lancet HIV ; 4(9): e393-e401, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28579225

RESUMO

BACKGROUND: HIV disease staging with referral laboratory-based CD4 cell count testing is a key barrier to the initiation of antiretroviral treatment (ART). Point-of-care CD4 cell counts can improve linkage to HIV care among people living with HIV, but its effect has not been assessed with a randomised controlled trial in the context of home-based HIV counselling and testing (HBCT). METHODS: We did a two-arm, cluster-randomised, controlled efficacy trial in two districts of western Kenya with ongoing HBCT. Housing compounds were randomly assigned (1:1) to point-of-care CD4 cell counts (366 compounds with 417 participants) or standard-of-care (318 compounds with 353 participants) CD4 cell counts done at one of three referral laboratories serving the study catchment area. In each compound, we enrolled people with HIV not engaged in care in the previous 6 months. All participants received post-test counselling and referral for HIV care. Point-of-care test participants received additional counselling on the result, including ART eligibility if CD4 was less than 350 cells per µL, the cutoff in Kenyan guidelines. Participants were interviewed 6 months after enrolment to ascertain whether they sought HIV care, verified through chart reviews at 23 local clinics. The prevalence of loss to follow-up at 6 months (LTFU) was listed as the main outcome in the study protocol. We analysed linkage to care at 6 months (defined as 1-LTFU) as the primary outcome. All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT02515149. FINDINGS: We enrolled 770 participants between July 1, 2013, and Feb 28, 2014. 692 (90%) had verified linkage to care status and 78 (10%) were lost to follow-up. Of 371 participants in the point-of-care group, 215 (58%) had linked to care within 6 months versus 108 (34%) of 321 in the standard-of-care group (Cox proportional multivariable hazard ratio [HR] 2·14, 95% CI 1·67-2·74; log rank p<0·0001). INTERPRETATION: Point-of-care CD4 cell counts in a resource-limited HBCT setting doubled linkage to care and thereby improved ART initiation. Given the substantial economic and logistic hindrances to providing ART for all people with HIV in resource-limited settings in the near term, point of care CD4 cell counts might have a role in prioritising care and improving linkage to care. FUNDING: US Centers for Disease Control and Prevention.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4/instrumentação , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Sistemas Automatizados de Assistência Junto ao Leito , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Contagem de Linfócito CD4/métodos , Aconselhamento , Feminino , Infecções por HIV/classificação , Infecções por HIV/epidemiologia , Humanos , Quênia/epidemiologia , Perda de Seguimento , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Carga Viral , Adulto Jovem
4.
J Immunol Methods ; 448: 44-50, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28529048

RESUMO

BACKGROUND: CD4+ T-lymphocyte count testing at the point-of-care (POC) may improve linkage to care of persons diagnosed with HIV-1 infection, but the accuracy of POC devices when operated by lay-counselors in the era of task-shifting is unknown. We examined the accuracy of Alere's Pima™ POC device on both capillary and venous blood when performed by lay-counselors and laboratory technicians. METHODS: In Phase I, we compared the perfomance of POC against FACSCalibur™ for 280 venous specimens by laboratory technicians. In Phase II we compared POC performance by lay-counselors versus laboratory technicians using 147 paired capillary and venous specimens, and compared these to FACSCalibur™. Statistical analyses included Bland-Altman analyses, concordance correlation coefficient, sensitivity, and specificity at treatment eligibility thresholds of 200, 350, and 500cells/µl. RESULTS: Phase I: POC sensitivity and specificity were 93.0% and 84.1% at 500cells/µl, respectively. Phase II: Good agreement was observed for venous POC results from both lay-counselors (concordance correlation coefficient (CCC)=0.873, bias -86.4cells/µl) and laboratory technicians (CCC=0.920, bias -65.7cells/µl). Capillary POC had good correlation: lay-counselors (CCC=0.902, bias -71.2cells/µl), laboratory technicians (CCC=0.918, bias -63.0cells/µl). Misclassification at the 500 cells/µl threshold for venous blood was 13.6% and 10.2% for lay-counselors and laboratory technicians and 12.2% for capillary blood in both groups. POC tended to under-classify the CD4 values with increasingly negative bias at higher CD4 values. CONCLUSIONS: Pima™ results were comparable to FACSCalibur™ for both venous and capillary specimens when operated by lay-counselors. POC CD4 testing has the potential to improve linkage to HIV care without burdening laboratory technicians in resource-limited settings.


Assuntos
Contagem de Linfócito CD4/instrumentação , Técnicas de Laboratório Clínico , Agentes Comunitários de Saúde , Conselheiros , Infecções por HIV/diagnóstico , HIV-1/imunologia , Sistemas Automatizados de Assistência Junto ao Leito , Testes Imediatos , Contagem de Linfócito CD4/métodos , Erros de Diagnóstico , Desenho de Equipamento , Infecções por HIV/sangue , Infecções por HIV/imunologia , Infecções por HIV/virologia , Humanos , Quênia , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes
5.
Pharmacoepidemiol Drug Saf ; 26(1): 17-25, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27891698

RESUMO

PURPOSE: In March 1992, eight infants who had died within 36 hours of receiving whole-cell pertussis vaccine (diphtheria, tetanus, and whole-cell pertussis [DTwP]) prompted the Taiwan health authorities to suspend its use. We conducted an investigation of vaccination and sudden unexplained infant death (SUID) and repeated it more recently after Taiwan switched to acellular pertussis vaccine (diphtheria, tetanus, and acellular pertussis [DTaP]) in 2010. METHODS: All SUIDs aged 31-364 days during 1990-1992 and 1996-2013 were selected from the death registration databases. The case-control investigation matched each case to two controls on clinic, sex, and birth date, whereas the follow-up self-controlled case series study compared risk of death during the 30-day post-vaccination risk periods with those in the control periods within the same case. RESULTS: Sudden unexplained infant death was associated with never receiving DTwP (odds ratio 2.28, 95% confidence interval 1.25-4.15) in the case-control investigation. The odds ratios within 0-1, 2-7, 8-14, and 15-30 days of DTwP administration were 1.18, 0.26, 0.50, and 0.77. In the 1996-2013 self-controlled case series studies, this temporal shift between DTwP and SUID was consistently observed for female (incidence rate ratio 1.70, 0.75, 1.01, and 0.84) but not male or DTaP recipients. A pooled analysis showed significant risk within 2 days of receiving DTwP in female infants (incidence rate ratio 1.66, 95% confidence interval 1.05-2.60). CONCLUSIONS: Being unvaccinated and recent receipt of DTwP in female infants was significantly associated with SUID; the latter was consistent with a temporal shift pattern without overall increase in risk. The currently used pertussis vaccine, DTaP, did not increase risk of SUID. Copyright © 2016 John Wiley & Sons, Ltd.


Assuntos
Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Morte Súbita do Lactente/epidemiologia , Estudos de Casos e Controles , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacinas contra Difteria, Tétano e Coqueluche Acelular/efeitos adversos , Feminino , Seguimentos , Humanos , Lactente , Masculino , Risco , Morte Súbita do Lactente/etiologia , Taiwan/epidemiologia , Fatores de Tempo , Vacinação/efeitos adversos , Vacinação/métodos
7.
Vaccine ; 34(51): 6597-6609, 2016 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-27395563

RESUMO

The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viral and other microbial pathogens in their genome (so-called "chimeric virus vaccines"). Many such viral vector vaccines are now at various stages of clinical evaluation. Here, we introduce an attenuated form of recombinant vesicular stomatitis virus (rVSV) as a potential chimeric virus vaccine for HIV-1, with implications for use as a vaccine vector for other pathogens. The rVSV/HIV-1 vaccine vector was attenuated by combining two major genome modifications. These modifications acted synergistically to greatly enhance vector attenuation and the resulting rVSV vector demonstrated safety in sensitive mouse and non-human primate neurovirulence models. This vector expressing HIV-1 gag protein has completed evaluation in two Phase I clinical trials. In one trial the rVSV/HIV-1 vector was administered in a homologous two-dose regimen, and in a second trial with pDNA in a heterologous prime boost regimen. No serious adverse events were reported nor was vector detected in blood, urine or saliva post vaccination in either trial. Gag specific immune responses were induced in both trials with highest frequency T cell responses detected in the prime boost regimen. The rVSV/HIV-1 vector also demonstrated safety in an ongoing Phase I trial in HIV-1 positive participants. Additionally, clinical trial material has been produced with the rVSV vector expressing HIV-1 env, and Phase I clinical evaluation will initiate in the beginning of 2016. In this paper, we use a standardized template describing key characteristics of the novel rVSV vaccine vectors, in comparison to wild type VSV. The template facilitates scientific discourse among key stakeholders by increasing transparency and comparability of information. The Brighton Collaboration V3SWG template may also be useful as a guide to the evaluation of other recombinant viral vector vaccines.


Assuntos
Vacinas contra a AIDS/efeitos adversos , Vacinas contra a AIDS/imunologia , Portadores de Fármacos , Vesiculovirus/genética , Vacinas contra a AIDS/genética , Animais , Ensaios Clínicos Fase I como Assunto , Avaliação Pré-Clínica de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Vetores Genéticos , Humanos , Primatas , Medição de Risco , Linfócitos T/imunologia , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/genética , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/genética , Vacinas Sintéticas/imunologia , Produtos do Gene env do Vírus da Imunodeficiência Humana/genética , Produtos do Gene env do Vírus da Imunodeficiência Humana/imunologia , Produtos do Gene gag do Vírus da Imunodeficiência Humana/genética , Produtos do Gene gag do Vírus da Imunodeficiência Humana/imunologia
8.
Vaccine ; 34(51): 6610-6616, 2016 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-27346303

RESUMO

In 2003 and 2013, the World Health Organization convened informal consultations on characterization and quality aspects of vaccines based on live virus vectors. In the resulting reports, one of several issues raised for future study was the potential for recombination of virus-vectored vaccines with wild type pathogenic virus strains. This paper presents an assessment of this issue formulated by the Brighton Collaboration. To provide an appropriate context for understanding the potential for recombination of virus-vectored vaccines, we review briefly the current status of virus-vectored vaccines, mechanisms of recombination between viruses, experience with recombination involving live attenuated vaccines in the field, and concerns raised previously in the literature regarding recombination of virus-vectored vaccines with wild type virus strains. We then present a discussion of the major variables that could influence recombination between a virus-vectored vaccine and circulating wild type virus and the consequences of such recombination, including intrinsic recombination properties of the parent virus used as a vector; sequence relatedness of vector and wild virus; virus host range, pathogenesis and transmission; replication competency of vector in target host; mechanism of vector attenuation; additional factors potentially affecting virulence; and circulation of multiple recombinant vectors in the same target population. Finally, we present some guiding principles for vector design and testing intended to anticipate and mitigate the potential for and consequences of recombination of virus-vectored vaccines with wild type pathogenic virus strains.


Assuntos
Portadores de Fármacos , Vetores Genéticos , Recombinação Genética , Vacinas Virais/efeitos adversos , Vacinas Virais/genética , Animais , Humanos , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/genética , Virulência , Vírus
9.
Vaccine ; 34(51): 6617-6625, 2016 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-27317264

RESUMO

Vaccines are one of the most effective public health medicinal products with an excellent safety record. As vaccines are produced using biological materials, there is a need to safeguard against potential contamination with adventitious agents. Adventitious agents could be inadvertently introduced into a vaccine through starting materials used for production. Therefore, extensive testing has been recommended at specific stages of vaccine manufacture to demonstrate the absence of adventitious agents. Additionally, the incorporation of viral clearance steps in the manufacturing process can aid in reducing the risk of adventitious agent contamination. However, for live viral vaccines, aside from possible purification of the virus or vector, extensive adventitious agent clearance may not be feasible. In the event that an adventitious agent is detected in a vaccine, it is important to determine its origin, evaluate its potential for human infection and pathology, and discern which batches of vaccine may have been affected in order to take risk mitigation action. To achieve this, it is necessary to have archived samples of the vaccine and ancillary components, ideally from developmental through to current batches, as well as samples of the biological materials used in the manufacture of the vaccine, since these are the most likely sources of an adventitious agent. The need for formal guidance on such vaccine sample archiving has been recognized but not fulfilled. We summarize in this paper several prior major cases of vaccine contamination with adventitious agents and provide points for consideration on sample archiving of live recombinant viral vector vaccines for use in humans.


Assuntos
Contaminação de Medicamentos , Preservação Biológica , Tecnologia Farmacêutica , Vacinas Virais/isolamento & purificação , Cultura de Vírus , Animais , Humanos , Vacinas Atenuadas/isolamento & purificação
10.
Vaccine ; 34(29): 3342-9, 2016 06 17.
Artigo em Inglês | MEDLINE | ID: mdl-27195758

RESUMO

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally.


Assuntos
Comitês Consultivos/organização & administração , Qualidade de Produtos para o Consumidor , Vacinas/normas , Política de Saúde , Humanos , Organização Mundial da Saúde
11.
J Int Assoc Provid AIDS Care ; 15(1): 42-50, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-24309755

RESUMO

Cost-effective HIV prevention programs should target persons at high risk of HIV acquisition. We conducted an observational HIV incidence cohort study in Kisumu, Kenya, where HIV prevalence is triple that of the national rate. We used referral and venue-sampling approaches to enroll HIV-negative persons for a 12-month observational cohort, August 2010 to September 2011, collected data using computer-assisted interviews, and performed HIV testing quarterly. Among 1292 eligible persons, 648 (50%) were excluded for HIV positivity and other reasons. Of the 644 enrollees, 52% were women who were significantly older than men (P<.01). In all, 7 persons seroconverted (incidence rate [IR] per 100 person-years=1.11; 95% confidence interval [CI] 0.45-2.30), 6 were women; 5 (IR=3.14; 95% CI 1.02-7.34) of whom were ≤25 years. Most new infections occurred in young women, an observation consistent with other findings in sub-Saharan Africa that women aged ≤25 years are an important population for HIV intervention trials in Africa.


Assuntos
Infecções por HIV/epidemiologia , Adolescente , Adulto , Feminino , Infecções por HIV/prevenção & controle , Infecções por HIV/psicologia , Humanos , Incidência , Quênia/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Assunção de Riscos , Adulto Jovem
12.
Am J Prev Med ; 49(6 Suppl 4): S364-76, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26590436

RESUMO

Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a "lifecycle" approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries.


Assuntos
Saúde Global , Segurança , Vacinas/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , Países Desenvolvidos , Países em Desenvolvimento , Controle de Medicamentos e Entorpecentes , Humanos , Programas de Imunização , Esquemas de Imunização , Medicina de Precisão , Gestantes , Vigilância de Produtos Comercializados/métodos , Projetos de Pesquisa , Medição de Risco , Biologia de Sistemas
13.
Vaccine ; 33 Suppl 4: D46-54, 2015 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-26433922

RESUMO

Major vaccine safety controversies have arisen in several countries beginning in the last decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away in the near future as more national immunization programs mature with near elimination of target vaccine-preventable diseases that result in relative greater prominence of adverse events following immunizations, both true reactions and temporally coincidental events. There are several ways in which vaccine safety capacity can be improved to potentially mitigate the impact of future vaccine safety controversies. This paper aims to take a "lifecycle" approach, examining some potential pre- and post-licensure opportunities to improve vaccine safety, in both developed (specifically U.S. and Europe) and low- and middle-income countries.


Assuntos
Programas de Imunização , Vacinas/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , Aprovação de Drogas , Europa (Continente) , Humanos , Licenciamento , Vigilância de Produtos Comercializados , Segurança , Estados Unidos , Vacinação
14.
Vaccine ; 33(1): 62-72, 2015 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-25446819

RESUMO

The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viruses inserted into the backbone of another virus (so-called "chimeric virus vaccines"). Many viral vector vaccines are in advanced clinical trials. The first such vaccine to be approved for marketing (to date in Australia, Thailand, Malaysia, and the Philippines) is a vaccine against the flavivirus, Japanese encephalitis (JE), which employs a licensed vaccine (yellow fever 17D) as a vector. In this vaccine, two envelope proteins (prM-E) of YF 17D virus were exchanged for the corresponding genes of JE virus, with additional attenuating mutations incorporated into the JE gene inserts. Similar vaccines have been constructed by inserting prM-E genes of dengue and West Nile into YF 17D virus and are in late stage clinical studies. The dengue vaccine is, however, more complex in that it requires a mixture of four live vectors each expressing one of the four dengue serotypes. This vaccine has been evaluated in multiple clinical trials. No significant safety concerns have been found. The Phase 3 trials met their endpoints in terms of overall reduction of confirmed dengue fever, and, most importantly a significant reduction in severe dengue and hospitalization due to dengue. However, based on results that have been published so far, efficacy in preventing serotype 2 infection is less than that for the other three serotypes. In the development of these chimeric vaccines, an important series of comparative studies of safety and efficacy were made using the parental YF 17D vaccine virus as a benchmark. In this paper, we use a standardized template describing the key characteristics of the novel flavivirus vaccine vectors, in comparison to the parental YF 17D vaccine. The template facilitates scientific discourse among key stakeholders by increasing the transparency and comparability of information. The Brighton Collaboration V3SWG template may also be useful as a guide to the evaluation of other recombinant viral vector vaccines.


Assuntos
Portadores de Fármacos , Vetores Genéticos , Vacinas Virais/efeitos adversos , Vacinas Virais/genética , Vírus da Febre Amarela/genética , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/genética , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/genética
15.
Int J STD AIDS ; 26(13): 929-40, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25505039

RESUMO

We estimated HIV prevalence and identified correlates of HIV infection among 1106 men and women aged 16-34 years residing in Kisumu, Kenya. Demographic, sexual, and other behavioural data were collected using audio computer-assisted self-interview in conjunction with a medical examination, real-time parallel rapid HIV testing, and laboratory testing for pregnancy, gonorrhoea, chlamydia, syphilis, and herpes simplex virus type 2. Multivariate logistic regression was used to identify variables associated with prevalent HIV infection by gender. Overall HIV prevalence was 12.1%. HIV prevalence among women (17.1%) was approximately two-and-one-half times the prevalence among men (6.6%). Odds of HIV infection in men increased with age (aOR associated with one-year increase in age = 1.21, CI = 1.07-1.35) and were greater among those who were uncircumcised (aOR = 4.42, CI = 1.41-13.89) and those who had an herpes simplex virus type 2-positive (aOR = 3.13, CI = 1.12-8.73) test result. Odds of prevalent HIV infection among women also increased with age (aOR associated with one-year increase in age = 1.16, CI = 1.04-1.29). Women who tested herpes simplex virus type 2 positive had more than three times the odds (aOR = 3.85, CI = 1.38-10.46) of prevalent HIV infection compared with those who tested herpes simplex virus type 2 negative. Tailored sexual health interventions and programs may help mitigate HIV age and gender disparities.


Assuntos
Infecções por HIV/epidemiologia , Adolescente , Adulto , Fatores Etários , Circuncisão Masculina , Estudos Transversais , Feminino , Gonorreia/epidemiologia , Herpes Genital/epidemiologia , Humanos , Incidência , Quênia/epidemiologia , Modelos Logísticos , Masculino , Análise Multivariada , Prevalência , Estudos Prospectivos , Fatores de Risco , Fatores Sexuais , Fatores Socioeconômicos , Adulto Jovem
16.
Vaccine ; 33(1): 73-5, 2015 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-25305565

RESUMO

Recombinant viral vectors provide an effective means for heterologous antigen expression in vivo and thus represent promising platforms for developing novel vaccines against human pathogens from Ebola to tuberculosis. An increasing number of candidate viral vector vaccines are entering human clinical trials. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to improve our ability to anticipate potential safety issues and meaningfully assess or interpret safety data, thereby facilitating greater public acceptance when licensed.


Assuntos
Portadores de Fármacos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Vetores Genéticos , Cooperação Internacional , Vacinas Virais/efeitos adversos , Ensaios Clínicos como Assunto , Humanos , Vacinas Sintéticas/efeitos adversos , Vacinas Sintéticas/genética , Vacinas Sintéticas/imunologia , Vacinas Virais/genética , Vacinas Virais/imunologia
17.
J Int Assoc Provid AIDS Care ; 14(1): 33-9, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-24899259

RESUMO

INTRODUCTION: In 2012, the American Academy of Pediatrics (AAP) and the American Congress of Obstetricians and Gynecologists (ACOG) published recommendations that physicians should discuss with parents the benefits and risks of newborn male circumcision. Our objective was to assess physicians' perspectives of newborn male circumcision. METHODS: A self-administered, cross-sectional electronic survey of US physicians was conducted in 2008 (N = 1500). RESULTS: Approximately one-third (33.2%) of the respondents reported that their current perspective was that the medical benefits outweigh the risks associated with newborn male circumcision and less than one-third (31.1%) reported they would recommend the procedure when counseling parents. CONCLUSIONS: In 2008, only about one-third of the physicians surveyed thought that the benefits of male circumcision outweighed the risks and recommended it to parents of newborn sons. These attitudes may be relevant to the declining circumcision rates in the United States. Repeat surveys may be useful, given the new AAP and ACOG recommendations.


Assuntos
Atitude do Pessoal de Saúde , Circuncisão Masculina , Médicos/psicologia , Médicos/estatística & dados numéricos , Adulto , Circuncisão Masculina/efeitos adversos , Circuncisão Masculina/psicologia , Circuncisão Masculina/estatística & dados numéricos , Estudos Transversais , Feminino , Humanos , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Medição de Risco , Estados Unidos/epidemiologia
18.
J Homosex ; 61(12): 1712-26, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25089554

RESUMO

Men who have sex with men (MSM) are a crucial and marginalized at risk population for HIV in Africa but are poorly studied. Like other areas of Africa, homosexuality is illegal in Kenya. We assessed MSM comfort in accessing health services and willingness to participate in HIV prevention research in Kisumu, Kenya-an area of high HIV prevalence. We conducted a two-phase formative study with individual interviews (n = 15) and a structured survey (n = 51). Peer contact or snowball method (n = 43, 84.3%) was the primary recruitment strategy used to locate MSM. Exact logistic regression models were used for survey data analysis. Over 60% (32/51) of survey participants were not very comfortable seeking health services from a public hospital. Almost all MSM (49/51; 96.1%) reported willingness to be contacted to participate in future HIV research studies. Efforts to provide facilities that offer safe and confidential health services and health education for MSM is required. Continued community engagement with the MSM population in Kenya is needed to guide best practices for involving them in HIV prevention research.


Assuntos
Infecções por HIV/prevenção & controle , Acesso aos Serviços de Saúde , Homossexualidade Masculina , Adolescente , Adulto , Pesquisa Biomédica , Coleta de Dados , Infecções por HIV/psicologia , Homossexualidade Masculina/psicologia , Homossexualidade Masculina/estatística & dados numéricos , Humanos , Entrevistas como Assunto , Quênia/epidemiologia , Masculino , Pessoa de Meia-Idade , Sujeitos da Pesquisa/psicologia , Sujeitos da Pesquisa/estatística & dados numéricos , Adulto Jovem
19.
JAMA Pediatr ; 168(7): 625-34, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24820907

RESUMO

IMPORTANCE: Approximately 1.4 million male circumcisions (MCs) are performed annually in US medical settings. However, population-based estimates of MC-associated adverse events (AEs) are lacking. OBJECTIVES: To estimate the incidence rate of MC-associated AEs and to assess whether AE rates differed by age at circumcision. DESIGN: We selected 41 possible MC AEs based on a literature review and on medical billing codes. We estimated a likely risk window for the incidence calculation for each MC AE based on pathogenesis. We used 2001 to 2010 data from SDI Health, a large administrative claims data set, to conduct a retrospective cohort study. SETTING AND PARTICIPANTS: SDI Health provided administrative claims data from inpatient and outpatient US medical settings. MAIN OUTCOMES AND MEASURES: For each AE, we calculated the incidence per million MCs. We compared the incidence risk ratio and the incidence rate difference for circumcised vs uncircumcised newborn males and for males circumcised at younger than 1 year, age 1 to 9 years, or 10 years or older. An AE was considered probably related to MC if the incidence risk ratio significantly exceeded 1 at P < .05 or occurred only in circumcised males. RESULTS: Records were available for 1,400,920 circumcised males, 93.3% as newborns. Of 41 possible MC AEs, 16 (39.0%) were probable. The incidence of total MC AEs was slightly less than 0.5%. Rates of potentially serious MC AEs ranged from 0.76 (95% CI, 0.10-5.43) per million MCs for stricture of male genital organs to 703.23 (95% CI, 659.22-750.18) per million MCs for repair of incomplete circumcision. Compared with boys circumcised at younger than 1 year, the incidences of probable AEs were approximately 20-fold and 10-fold greater for males circumcised at age 1 to 9 years and at 10 years or older, respectively. CONCLUSIONS AND RELEVANCE: Male circumcision had a low incidence of AEs overall, especially if the procedure was performed during the first year of life, but rose 10-fold to 20-fold when performed after infancy.


Assuntos
Circuncisão Masculina/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Fatores Etários , Criança , Pré-Escolar , Circuncisão Masculina/efeitos adversos , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Estados Unidos/epidemiologia
20.
Int J STD AIDS ; 25(12): 851-9, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-24516075

RESUMO

While laboratory aetiological diagnosis is considered the gold standard for diagnosis and management of sexually transmitted infections (STIs), syndromic management has been presented as a simplified and affordable approach for STI management in limited resource settings. STI signs and symptoms were collected using staff-administered computer-assisted personal interview and audio computer-assisted self-interview. Participants underwent a medical examination and laboratory testing for common STIs. The performance of syndromic management was assessed on the agreement between interviewing methods as well as accurate diagnosis. We screened 846 participants, of whom 88 (10.4%) received syndromic STI diagnosis while 272 (32.2%) received an aetiological diagnosis. Agreement between syndromic and aetiological diagnoses was very poor (overall kappa = 0.09). The most prevalent STI was herpes simplex virus type 2 and the percentage of persons with any STI was higher among women (48.6%) than men (15.6%, p < 0.0001). Agreement between audio computer-assisted self-interview and computer-assisted personal interview interviewing methods for syndromic diagnosis of STIs ranged from poor to good. Our findings suggest that syndromic management of STIs is not a sufficient tool for STI diagnosis in this setting; development and improvement of STI diagnostic capabilities through laboratory confirmation is needed in resource-limited settings.


Assuntos
Entrevistas como Assunto/métodos , Doenças Sexualmente Transmissíveis/diagnóstico , Doenças Sexualmente Transmissíveis/etiologia , Adolescente , Adulto , Gerenciamento Clínico , Feminino , Infecções por HIV/epidemiologia , Humanos , Incidência , Quênia/epidemiologia , Masculino , Exame Físico , Prevalência , Autocuidado , Distribuição por Sexo , Doenças Sexualmente Transmissíveis/epidemiologia , Fatores Socioeconômicos
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