Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.

Abstract:

Background:Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT). Objective:To determine the safety and efficacy of Triplex. Design:First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933). Setting:3 U.S. HCT centers. Participants:102 CMV-seropositive HCT recipients at high risk for CMV reactivation. Intervention:Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens. Measurements:The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatment, or end-organ disease), nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD), all evaluated through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination that were probably or definitely attributable to injection. Results:A total of 102 patients (51 per group) received the first vaccination, and 91 (89.2%) received both vaccinations (46 Triplex and 45 placebo). Reactivation of CMV occurred in 5 Triplex (9.8%) and 10 placebo (19.6%) recipients (hazard ratio, 0.46 [95% CI, 0.16 to 1.4]; P = 0.075). No Triplex recipient died of nonrelapse causes during the first 100 days or had serious AEs, and no grade 3 or 4 AEs related to vaccination were observed within 2 weeks after vaccination. Incidence of severe acute GVHD after injection was similar between groups (hazard ratio, 1.1 [CI, 0.53 to 2.4]; P = 0.23). Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients. Limitation:The lower-than-expected incidence of CMV events in the placebo group reduced the power of the trial. Conclusion:No vaccine-associated safety concerns were identified. Triplex elicited and amplified CMV-specific immune responses, and fewer Triplex-vaccinated patients had CMV viremia. Primary Funding Source:National Cancer Institute and Helocyte.

journal_name

Ann Intern Med

authors

Aldoss I,La Rosa C,Baden LR,Longmate J,Ariza-Heredia EJ,Rida WN,Lingaraju CR,Zhou Q,Martinez J,Kaltcheva T,Dagis A,Hardwick N,Issa NC,Farol L,Nademanee A,Al Malki MM,Forman S,Nakamura R,Diamond DJ,TRIPLEX VACCINE St

doi

10.7326/M19-2511

subject

Has Abstract

pub_date

2020-03-03 00:00:00

pages

306-316

issue

5

eissn

0003-4819

issn

1539-3704

pii

2760880

journal_volume

172

pub_type

杂志文章,多中心研究,随机对照试验
  • The long-term therapeutic management of epilepsy.

    abstract:OBJECTIVE:To provide a rational strategy for the evaluation and long-term management of epilepsy. DATA SOURCES:Articles written between 1964 and 1993, obtained from a MEDLINE search on epilepsy-related topics as well as from the author's personal files, major reference books on antiepileptic drugs, and references iden...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-120-5-199403010-00010

    authors: French J

    更新日期:1994-03-01 00:00:00

  • Granulomatous hepatitis secondary to carbamazepine.

    abstract::Three cases of carbamazepine-induced granulomatous hepatitis are reported. Each patient had ingested carbamazepine for less than 1 month before presenting with a febrile illness suggestive of biliary tract infection. After withdrawal of carbamazepine, symptoms disappeared rapidly. Histologically, all patients had gran...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-95-1-64

    authors: Levy M,Goodman MW,Van Dyne BJ,Sumner HW

    更新日期:1981-07-01 00:00:00

  • Evidence-based therapies and mortality in patients hospitalized in December with acute myocardial infarction.

    abstract:BACKGROUND:Previous studies suggest that patients hospitalized with acute myocardial infarction (MI) in December have poor outcomes, and some studies have hypothesized that the cause may be the infrequent use of evidence-based therapies during the December holiday season. OBJECTIVE:To compare the care and outcomes of ...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-143-7-200510040-00006

    authors: Meine TJ,Patel MR,DePuy V,Curtis LH,Rao SV,Gersh BJ,Schulman KA,Jollis JG

    更新日期:2005-10-04 00:00:00

  • Physical examination for exclusion of hemodynamically important right ventricular infarction.

    abstract::Fifty-three consecutive patients with inferior myocardial infarction were evaluated prospectively, by physical examination and right heart catheterization within 36 hours of the onset of symptoms, to determine whether physical findings can separate such patients into those with and without associated right ventricular...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-99-5-608

    authors: Dell'Italia LJ,Starling MR,O'Rourke RA

    更新日期:1983-11-01 00:00:00

  • Acute renal infection in women: treatment with trimethoprim-sulfamethoxazole or ampicillin for two or six weeks. A randomized trial.

    abstract::We compared the efficacy of orally administered ampicillin, 2 g/d, with that of trimethoprim-sulfamethoxazole, 320 mg/d-1600 mg/d, given for 2 or 6 weeks for outpatient management of acute uncomplicated renal infection in women. Of 98 women participating in the trial, 60 had renal infections with susceptible strains, ...

    journal_title:Annals of internal medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.7326/0003-4819-106-3-341

    authors: Stamm WE,McKevitt M,Counts GW

    更新日期:1987-03-01 00:00:00

  • Quantitative Results of a National Intervention to Prevent Central Line-Associated Bloodstream Infection: A Pre-Post Observational Study.

    abstract:Background:Central line-associated bloodstream infection (CLABSI) remains prevalent in hospitals in the United States. Objective:To evaluate the impact of a multimodal intervention in hospitals with elevated rates of health care-associated infection. Design:Pre-post observational evaluation of a prospective, national...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,多中心研究

    doi:10.7326/M18-3533

    authors: Patel PK,Greene MT,Jones K,Rolle AJ,Ratz D,Snyder A,Saint S,Chopra V

    更新日期:2019-10-01 00:00:00

  • Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder: Synopsis of the Kidney Disease: Improving Global Outcomes 2017 Clinical Practice Guideline Update.

    abstract:Description:The Kidney Disease: Improving Global Outcomes (KDIGO) 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) is a selective update of the prior CKD-MBD guideline published in 2009. The guideline update an...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,实务指引

    doi:10.7326/M17-2640

    authors: Ketteler M,Block GA,Evenepoel P,Fukagawa M,Herzog CA,McCann L,Moe SM,Shroff R,Tonelli MA,Toussaint ND,Vervloet MG,Leonard MB

    更新日期:2018-03-20 00:00:00

  • Aspirin-induced ultrastructural changes in human gastric mucosa: correlation with potential difference.

    abstract::Aspirin breaks the gastric mucosal barrier. We studied the effect of aspirin on this barrier, correlating changes in potential difference and ultrastructure. Mean control potential difference for seven subjects was -48 +/- 1.0 mV. Oral aspirin, 600 mg in 100 ml of saline, reduced potential difference to -39 +/- 1.4 mV...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-85-3-299

    authors: Baskin WN,Ivey KJ,Krause WJ,Jeffrey GE,Gemmell RT

    更新日期:1976-09-01 00:00:00

  • Descriptive epidemiology of body weight and weight change in U.S. adults.

    abstract::Data on body weight and weight change collected from nationally representative samples of U.S. adults are reviewed. The body mass index (weight [kg]/height [m2]) has a low correlation with height and is used to compare body weights between persons of differing heights. The BMI varies to a greater degree in women than ...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-119-7_part_2-199310011-00004

    authors: Williamson DF

    更新日期:1993-10-01 00:00:00

  • e Antigen in hepatitis B virus infected dialysis patients: assessment of its prognostic value.

    abstract::Many investigations consider the presence of e antigen (HBeAg) valuable in predicting which patients with acute hepatitis B are at risk of remaining infected and developing chronic liver disease. We tested this hypothesis in a retrospective study of serial samples from patients undergoing long-term hemodialysis. We fo...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-89-3-310

    authors: Werner BG,Blumberg BS

    更新日期:1978-09-01 00:00:00

  • Access to care is the centerpiece in the elimination of socioeconomic disparities in health.

    abstract::Many health care professionals have sustained an almost single-minded conviction that disparities in access to health care across socioeconomic groups are the key reason for the major discrepancies in health status between wealthy persons and poor persons. Others, however, have argued that a host of factors work to cr...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-129-5-199809010-00012

    authors: Andrulis DP

    更新日期:1998-09-01 00:00:00

  • Does performance-based remuneration for individual health care practitioners affect patient care?: a systematic review.

    abstract:BACKGROUND:Pay-for-performance (P4P) is increasingly touted as a means to improve health care quality. PURPOSE:To evaluate the effect of P4P remuneration targeting individual health care providers. DATA SOURCES:MEDLINE, EMBASE, Cochrane Library, OpenSIGLE, Canadian Evaluation Society Unpublished Literature Bank, New ...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-157-12-201212180-00009

    authors: Houle SK,McAlister FA,Jackevicius CA,Chuck AW,Tsuyuki RT

    更新日期:2012-12-18 00:00:00

  • Management of influenza in adults older than 65 years of age: cost-effectiveness of rapid testing and antiviral therapy.

    abstract:BACKGROUND:Although antiviral therapy is cost-effective in adults, its cost-effectiveness in older adults has not been studied. OBJECTIVE:To determine the cost-effectiveness of influenza testing and treatment strategies for older adults. DESIGN:Cost-utility decision model. DATA SOURCES:Clinical trials of antiviral d...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-139-5_part_1-200309020-00007

    authors: Rothberg MB,Bellantonio S,Rose DN

    更新日期:2003-09-02 00:00:00

  • Meta-analysis: the effect of steroids on survival and shock during sepsis depends on the dose.

    abstract:BACKGROUND:Previous meta-analyses demonstrated that high-dose glucocorticoids were not beneficial in sepsis. Recently, lower-dose glucocorticoids have been studied. PURPOSE:To compare recent trials of glucocorticoids for sepsis with previous glucocorticoid trials. DATA SOURCES:Systematic MEDLINE search for studies pu...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,meta分析,评审

    doi:10.7326/0003-4819-141-1-200407060-00014

    authors: Minneci PC,Deans KJ,Banks SM,Eichacker PQ,Natanson C

    更新日期:2004-07-06 00:00:00

  • Absence of echocardiographic abnormalities of the anterior mitral valve leaflet in rheumatoid arthritis.

    abstract::Thirty-five consecutives patients with classic or definite rheumatoid arthritis underwent echocardiography to evaluate the motion of the anterior mitral valve leaflet. Adequate echocardiograms were obtained in 31 patients. All 31 patients showed normal valve motion and a normal EF slope. If meticulous technique was no...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-83-4-500

    authors: Davia JE,Cheitlin MD,de Castro CM,Lawless O,Niemi L

    更新日期:1975-10-01 00:00:00

  • Cisplatin, vinblastine, and bleomycin in advanced and recurrent ovarian germ-cell tumors. A trial of the Gynecologic Oncology Group.

    abstract:STUDY OBJECTIVE:To evaluate the efficacy of cisplatin-based combination chemotherapy in patients with advanced ovarian germ-cell tumors. DESIGN:Nonrandom prospective trial with endpoints of tumor response, results of repeat surgical exploration, progression-free interval, and survival. SETTING:Cooperative university-...

    journal_title:Annals of internal medicine

    pub_type: 临床试验,杂志文章

    doi:10.7326/0003-4819-111-1-22

    authors: Williams SD,Blessing JA,Moore DH,Homesley HD,Adcock L

    更新日期:1989-07-01 00:00:00

  • Thromboendarterectomy for chronic, major-vessel thromboembolic pulmonary hypertension. Immediate and long-term results in 42 patients.

    abstract::Since 1970, forty-two patients with pulmonary hypertension due to chronic, thromboembolic obstruction of the major pulmonary arteries have had pulmonary thromboendarterectomy at the University of California, San Diego, and the San Diego Veterans Medical Centers. Duration of symptoms before admission averaged 4.4 years...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-107-4-560

    authors: Moser KM,Daily PO,Peterson K,Dembitsky W,Vapnek JM,Shure D,Utley J,Archibald C

    更新日期:1987-10-01 00:00:00

  • Acute decompensation after removing a central line: practical approaches to increasing safety in the intensive care unit.

    abstract::Intensive care is one of the largest, most expensive, and complex components of U.S. health care. Errors and the resulting adverse events are, however, common in intensive care units (ICUs). Theories about errors in high-risk environments, developed by aviation and other industries, provide insight into why ICUs are p...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-140-12-200406150-00013

    authors: Pronovost PJ,Wu AW,Sexton JB

    更新日期:2004-06-15 00:00:00

  • SGLT2 inhibitors increase risk for diabetic ketoacidosis in type 2 diabetes.

    abstract:SOURCE CITATION:Liu J, Li L, Li S, et al. Sodium-glucose co-transporter-2 inhibitors and the risk of diabetic ketoacidosis in patients with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2020;22:1619-27. 32364674. ...

    journal_title:Annals of internal medicine

    pub_type: 评论,杂志文章

    doi:10.7326/ACPJ202010200-040

    authors: Griffin TP,Dinneen SF

    更新日期:2020-10-20 00:00:00

  • The irritable bowel syndrome: review and a graduated multicomponent treatment approach.

    abstract::The irritable bowel syndrome is a common chronic disorder having a broad clinical spectrum of severity. Although only a small proportion of those afflicted seek medical help for their symptoms, a subset have severe and intractable symptoms. A positive diagnosis should be established from the history and physical exami...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-116-12-1009

    authors: Drossman DA,Thompson WG

    更新日期:1992-06-15 00:00:00

  • Electronic health records: just around the corner? Or over the cliff?

    abstract::We recently implemented a full-featured electronic health record in our independent, 4-internist, community-based practice of general internal medicine. We encountered various challenges, some unexpected, in moving from paper to computer. This article describes the effects that use of electronic health records has had...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-143-3-200508020-00008

    authors: Baron RJ,Fabens EL,Schiffman M,Wolf E

    更新日期:2005-08-02 00:00:00

  • Cost-effectiveness of using pharmacogenetic information in warfarin dosing for patients with nonvalvular atrial fibrillation.

    abstract:BACKGROUND:Variants in genes involved in warfarin metabolism and sensitivity affect individual warfarin requirements and the risk for bleeding. Testing for these variant alleles might allow more personalized dosing of warfarin during the induction phase. In 2007, the U.S. Food and Drug Administration changed the labeli...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-150-2-200901200-00005

    authors: Eckman MH,Rosand J,Greenberg SM,Gage BF

    更新日期:2009-01-20 00:00:00

  • Amantadine effect on peripheral airways abnormalities in influenza. A study in 15 students with natural influenza A infection.

    abstract::Amantadine HCl administration has resulted in accelerated resolution of influenza A illness. Prolonged abnormalities in pulmonary function have been described in uncomplicated influenza A. To study the effect of amantadine on these changes, we evaluated young adults with documented natural influenza A with clear chest...

    journal_title:Annals of internal medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.7326/0003-4819-85-2-177

    authors: Little JW,Hall WJ,Douglas RG Jr,Hyde RW,Speers DM

    更新日期:1976-08-01 00:00:00

  • Press releases by academic medical centers: not so academic?

    abstract:BACKGROUND:The news media are often criticized for exaggerated coverage of weak science. Press releases, a source of information for many journalists, might be a source of those exaggerations. OBJECTIVE:To characterize research press releases from academic medical centers. DESIGN:Content analysis. SETTING:Press rele...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-150-9-200905050-00007

    authors: Woloshin S,Schwartz LM,Casella SL,Kennedy AT,Larson RJ

    更新日期:2009-05-05 00:00:00

  • Chemotherapy of advanced small-cell anaplastic carcinoma. Superiority of a four-drug combination to a three-drug combination.

    abstract::A controlled clinical trial compared three-drug and four-drug combination chemotherapy in 109 patients with advanced small-cell anaplastic carcinoma of the lung. The combination of vincristine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU), cyclophosphamide, and methotrexate was significantly superior to the com...

    journal_title:Annals of internal medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.7326/0003-4819-89-2-177

    authors: Hansen HH,Dombernowsky P,Hansen M,Hirsch F

    更新日期:1978-08-01 00:00:00

  • Barrett's esophagus.

    abstract::Barrett's esophagus denotes the presence of columnar epithelium in the esophagus instead of the usual stratified squamous epithelium. Barrett's esophagus had been thought to represent a mediastinal extension of the stomach in patients with a congenital short esophagus. Subsequent clinical and experimental data have es...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,评审

    doi:10.7326/0003-4819-97-1-103

    authors: Bozymski EM,Herlihy KJ,Orlando RC

    更新日期:1982-07-01 00:00:00

  • Toward Historical Accountability and Remembrance: The German Society for Internal Medicine and Its Legacies From the Nazi Past.

    abstract::After decades of silence, the German Society for Internal Medicine (DGIM) has made considerable efforts to come to terms with its role and actions during the Nazi era (1933 to 1945). This is particularly important because, with more than 27 000 members, the DGIM is the largest medical society in present-day Germany. S...

    journal_title:Annals of internal medicine

    pub_type: 历史文章,杂志文章

    doi:10.7326/M20-0064

    authors: Hofer HG,Forsbach R,Fölsch UR

    更新日期:2020-09-01 00:00:00

  • No initial therapy for stage III and IV non-Hodgkin's lymphomas of favorable histologic types.

    abstract::The question of whether initial treatment is necessary in relatively asymptomatic patients with stage III and IV non-Hodgkin's lymphomas of favorable histologic types was studied by retrospective analysis. Two groups of patients were studied: [1] 44 nonprotocol patients, followed since 1963, in whom initial treatment ...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-90-1-10

    authors: Portlock CS,Rosenberg SA

    更新日期:1979-01-01 00:00:00

  • Gallium nitrate for advanced Paget disease of bone: effectiveness and dose-response analysis.

    abstract:OBJECTIVE:To evaluate whether a brief course of treatment with gallium nitrate can reduce biochemical parameters of accelerated bone turnover in patients with advanced Paget disease. DESIGN:Unblinded trial, decreasing dose schedules of gallium nitrate. SETTING:University hospital with primary orthopedic and metabolic...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章

    doi:10.7326/0003-4819-113-11-847

    authors: Warrell RP Jr,Bosco B,Weinerman S,Levine B,Lane J,Bockman RS

    更新日期:1990-12-01 00:00:00

  • How variability in the institutional review board review process affects minimal-risk multisite health services research.

    abstract:BACKGROUND:The Department of Health and Human Services recently called for public comment on human subjects research protections. OBJECTIVE:To assess variability in reviews across institutional review boards (IRBs) for a multisite, minimal-risk trial of financial incentives for evidence-based hypertension care and to ...

    journal_title:Annals of internal medicine

    pub_type: 杂志文章,多中心研究

    doi:10.7326/0003-4819-156-10-201205150-00011

    authors: Petersen LA,Simpson K,Sorelle R,Urech T,Chitwood SS

    更新日期:2012-05-15 00:00:00