scholarly journals Effects of Pregnancy and Isoniazid Preventive Therapy on Mycobacterium tuberculosis Interferon Gamma Response Assays in Women With HIV

2020 ◽  
Author(s):  
Adriana Weinberg ◽  
Lisa Aaron ◽  
Grace Montepiedra ◽  
Timothy R Sterling ◽  
Renee Browning ◽  
...  
Keyword(s):  
Mycobacterium Tuberculosis ◽  
Interferon Gamma ◽  
Inflammatory Responses ◽  
Latent Tuberculosis ◽  
Preventive Therapy ◽  
Isoniazid Preventive Therapy ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Consequences ◽  
Kappa Agreement

Abstract Background Pregnancy is accompanied by immune suppression. We hypothesized that Mycobacterium tuberculosis-specific inflammatory responses used to identify latent tuberculosis infection (LTBI) lose positivity during pregnancy. We also hypothesized that isoniazid preventive therapy (IPT) may revert LTBI diagnoses because of its sterilizing activity. Methods 944 women with human immunodeficiency virus infection (HIV) participating in a randomized, double-blind, placebo-controlled study comparing 28 weeks of IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST) at delivery and postpartum. Serial QGIT positivity was assessed by logistic regression using generalized estimating equations. Results From entry to delivery, 68 (24%) of 284 QGIT-positive women reverted to QGIT-negative or indeterminate. Of these, 42 (62%) recovered QGIT positivity postpartum. The loss of QGIT positivity during pregnancy was explained by decreased interferon gamma (IFNγ) production in response to TB antigen and/or mitogen. At delivery, LTBI was identified by QGIT in 205 women and by TST in 113 women. Corresponding numbers postpartum were 229 and 122 women. QGIT and TST kappa agreement coefficients were 0.4 and 0.5, respectively. Among QGIT-positive women antepartum or at delivery, 34 (12%) reverted to QGIT-negative after IPT. There were no differences between women who initiated IPT antepartum or postpartum. Conclusions Decreased IFNγ responses in pregnancy reduced QGIT positivity, suggesting that this test cannot reliably rule out LTBI during pregnancy. TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points. IPT was associated with loss of QGIT positivity, the potential clinical consequences of which need to be investigated.

scholarly journals Tuberculose latente entre pessoas com hiv/aids

2018 ◽  
Vol 12 (9) ◽  
pp. 2451
Author(s):  
Josiane Maria Oliveira Souza ◽  
Tayse Tâmara Paixão Duarte ◽  
Sandra Renata Nakashoji ◽  
Michelle Zampieri Ipolito ◽  
Marcia Cristina Silva Magro
Keyword(s):  
Interferon Gamma ◽  
Latent Tuberculosis ◽  
Therapy Response ◽  
Preventive Therapy ◽  
Isoniazid Preventive Therapy ◽  
People Living With Hiv ◽  
De Se ◽  
Tuberculose Latente ◽  
Hiv Aids

RESUMOObjetivo: buscar evidências sobre o uso da terapia preventiva com isoniazida na redução do risco da tuberculose ativa entre as pessoas vivendo com HIV/Aids mediante os resultados dos ensaios de liberação do interferon-gama (IGRA). Método: trata-se de estudo bibliográfico, descritivo, tipo revisão integrativa, com busca de artigos nas bases de dados publicados de 2010 a 2017. Os descritores utilizados foram HIV, AIDS, terapia preventiva com isoniazida, tratamento da infecção latente da tuberculose, interferon-gama, ensaios de liberação do interferon-gama. Resultados: selecionaram-se três artigos, com 1815 PVHA e desenvolvimento de tuberculose em apenas um caso, após 24 meses de terapia preventiva com isoniazida. Altas taxas de reversão e conversão durante o seguimento. Conclusão: consideraram-se os estudos abordando os benefícios da terapia preventiva com isoniazida a partir do resultado do IGRA apresentam-se escassos, com incipiente sugestão da limitação do teste seriado para o seguimento da resposta da terapia entre as PVHA. Além disso, destaca-se a necessidade de se investir em mais estudos que explorem a temática e superem as limitações já encontradas tendo em vista a alta relevância de se investir em novas estratégias que impactem o controle da coinfecção TB/HIV. Descritores: Tuberculose Latente; Teste Tuberculínico; Interferon-gama; HIV; Enfermagem; Prevenção de Doenças. ABSTRACT Objective: to search for evidence on the use of isoniazid preventive therapy in reducing the risk of active tuberculosis among people living with HIV / AIDS through the results of interferon-gamma (IGRA) release trials. Method: a descriptive, descriptive, integrative review type, with search of articles in the databases published from 2010 to 2017. The descriptors used were HIV, AIDS, isoniazid preventive therapy, treatment of latent tuberculosis infection, interferon-gamma, of interferon-gamma release. Results: three articles were selected, with 1815 PLHA and tuberculosis development in only one case, after 24 months of preventive therapy with isoniazid. High rates of reversal and conversion during follow-up. Conclusion: studies addressing the benefits of preventive therapy with isoniazid from the IGRA result are scarce, with an incipient suggestion of limiting the serial test for the follow-up of the therapy response among PLHA. In addition, there is a need to invest in more studies that explore the issue and overcome the limitations already encountered in view of the high relevance of investing in new strategies that impact the control of TB / HIV co-infection. Descriptors: Latent Tuberculosis; Tuberculin Test; Interferon-gamma; HIV; Nursing; Prevention of Diseases. RESUMEN Objetivo: buscar evidencias sobre el uso de la terapia preventiva con isoniazida en la reducción del riesgo de la tuberculosis activa entre las personas que viven con el VIH / SIDA, a través de los resultados de los ensayos de liberación del interferón gamma (IGRA). Método: estudio bibliográfico, descriptivo, tipo revisión integrativa, con búsqueda de artículos en las bases de datos publicados de 2010 a 2017. Los descriptores utilizados fueron: VIH, SIDA, terapia preventiva con isoniazida, tratamiento de la infección latente de la tuberculosis, interferón-gamma, ensayos de liberación del interferón-gamma. 0 se seleccionaron tres artículos, con 1815 PVHA y desarrollo de tuberculosis en apenas un caso, después de 24 meses de terapia preventiva con isoniazida. Altas tasas de reversión y conversión durante el seguimiento. Conclusión: los estudios abordando los beneficios de la terapia preventiva con isoniazida a partir del resultado del IGRA se presentan escasos, con incipiente sugerencia de la limitación de la prueba seriada para el seguimiento de la respuesta de la terapia, entre las PVHA. Además, se destaca la necesidad de invertir en más estudios que puedan explorar la temática y supere las limitaciones ya encontradas, visto la alta relevancia de invertir en nuevas estrategias que impacten en el control de la coinfección TB / VIH. Descritores: Tuberculosis Latente, Prueba de Tuberculina, Interferón Gamma; VIH, Enfermería; Prevención de Enfermedades.

scholarly journals Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 652 ◽  
Author(s):  
Artem P. Tkachuk ◽  
Evgeniia N. Bykonia ◽  
Liubov I. Popova ◽  
Denis A. Kleymenov ◽  
Maria A. Semashko ◽  
...  
Keyword(s):  
Interferon Gamma ◽  
Phase Ii ◽  
Intracellular Cytokine Staining ◽  
Study Drug ◽  
Controlled Study ◽  
Interferon Gamma Release Assay ◽  
Double Blind ◽  
Igra Test ◽  
Th1 Cytokine ◽  
Release Assay

GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette–Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4+ T-cells, and IgG responses and results support further clinical testing of GamTBvac.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

scholarly journals The Use of Interferon Gamma Release Assays in the Diagnosis of Active Tuberculosis

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Silvan M. Vesenbeckh ◽  
Nicolas Schönfeld ◽  
Harald Mauch ◽  
Thorsten Bergmann ◽  
Sonja Wagner ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Mycobacterium Tuberculosis ◽  
Interferon Gamma ◽  
Case Series ◽  
Latent Tuberculosis ◽  
Active Tuberculosis ◽  
Interferon Gamma Release Assays ◽  
Low Incidence ◽  
Low Prevalence

Interferon gamma release assays (IGRAs) arein vitroimmunologic diagnostic tests used to identifyMycobacterium tuberculosisinfection. They cannot differentiate between latent and active infections. The cutoff suggested by the manufacturer is 0.35 IU/mL for latent tuberculosis. As IGRA tests were recently approved for the differential diagnosis of active tuberculosis, we assessed the diagnostic accuracy of the latest generation IGRA for detection of active tuberculosis in a low-incidence area in Germany. Our consecutive case series includes 61 HIV negative,Mycobacterium tuberculosisculture positive patients, as well as 234 control patients. The retrospective analysis was performed over a period of two years. In 11/61 patients with active tuberculosis (18.0%) the test result was <0.35 IU/mL, resulting in a sensitivity of 0.82. We recommend establishing a new cut-off value for the differential diagnosis of active tuberculosis assessed by prospective clinical studies and in various regions with high and low prevalence of tuberculosis.

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