4 results match your criteria: "Durham (D.C.M.) - both in North Carolina; Quality Clinical Research[Affiliation]"
Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age.
N Engl J Med
May 2022
From the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine - both in Atlanta (E.A.); the Department of Pediatrics, Yale School of Medicine, the Department of Epidemiology of Microbial Diseases, Yale School of Public Health, and the Yale Institute for Global Health - all in New Haven, CT (I.Y.); the Medical University of South Carolina (A.M.A.) and Coastal Pediatric Associates (R.A.C.) - both in Charleston; Boca Raton Clinical Research Global, Edinburg (I.M.B.), Tekton Research, Austin (P.P.), Highland Woods Health, The Woodlands (C.Y.), Texas Health Care, Privia Medical Group-North Texas, Fort Worth, and Forest Lane Pediatrics, Dallas (R.B.) - all in Texas; Capitol Medical Group, Chevy Chase (D.F.), and the Department of Pediatrics, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (J.D.C.) - both in Maryland; Privia Medical Group, Arlington, VA (D.F., C.Y.); Velocity Clinical Research, Banning, CA (J.K.); Javara, Winston-Salem (C.Y., R.B.), and the Department of Surgery, Duke University Medical Center, Durham (D.C.M.) - both in North Carolina; Quality Clinical Research, Omaha, NE (M.D.); and Moderna, Cambridge, MA (J.E.T., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., R.D., J.M.M., S.S.G.).
Background: Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in children 6 to 11 years of age are unknown.
Methods: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled expansion evaluation of the selected dose.
Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.
N Engl J Med
April 2022
From the Divisions of Pulmonary and Critical Care Medicine and Allergy and Immunology, Brigham and Women's Hospital, Harvard Medical School (E.I., N.E.M., V.E.F., P.A.H., J.M.K., J.R.L., B.E.), and patient partner (O.T.), Boston, and the Lahey Hospital and Medical Center, Burlington (V.P.P.) - all in Massachusetts; the Division of Allergy and Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa (J.-C.C., T.B.C.), the Department of Nursing, University of Miami Health System (M.F.), and Miller School of Medicine, University of Miami (R.A.C.C.), Miami, the Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville (K.L.C.), and the University of Central Florida College of Medicine, Orlando (M.P.) - all in Florida; the Department of Family Medicine (J.K.C., W.D.P.) and the Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine (A.L.F.), University of Colorado, Aurora, the Public Leadership Group (G.M.H.), the Department of Medicine, National Jewish Health (M.E.W.), and the Denver Health and Hospital Authority (L.P.H.), Denver - all in Colorado; the American Academy of Family Physicians National Research Network, Leawood, KS (J.K.C., B.K.M., J.B.S.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (L.S., F.W.R.); the Department of Family and Community Health, University of Minnesota, Minneapolis (B.P.Y.), and patient partner, St. Paul (S.M.) - both in Minnesota; patient partner, South Jordan, UT (A.D.C.M.); the Division of Adolescent Medicine (T.C.B.) and the Lung Health Center, Department of Medicine, University of Alabama, Birmingham (J.T.); the American Lung Association, Washington, DC (B.M.K.); the Department of Medicine, Johns Hopkins School of Medicine, Baltimore (C.S.R.); patient partner (J.R.), the Divisions of General Internal Medicine and Pulmonary and Critical Care Medicine (J.P.W.) and Clinical Immunology and Allergy (P.J.B.), Icahn School of Medicine at Mount Sinai, and Montefiore Medical Center, (E.J.), Albert Einstein College of Medicine (M.D.M., S.P.J.) - all in New York; the Center for Clinical Informatics Research and Education, the MetroHealth System, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland (D.C.K.); the Department of Internal Medicine, Section of Allergy and Immunology, University of Puerto Rico, San Juan (S.N.); the Division of Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill (M.L.H.), the Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham (I.L.R.), and the Department of Family Medicine, Atrium Health, Charlotte (H.T.) - all in North Carolina; the Division of Pulmonary, Allergy, and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania (A.J.A.), and the Temple Lung Center, Lewis Katz School of Medicine at Temple University (K.S.) - both in Philadelphia; the University of Illinois at Chicago College of Pharmacy, Chicago (P.M.S.); the Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT (G.C.); and the Division of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles (A.B.).
Article Synopsis
- Black and Latinx adults with moderate-to-severe asthma were involved in a trial comparing a patient-activated inhaled glucocorticoid strategy (intervention) against usual care to address high asthma burdens in these populations.
- The results showed that the intervention group experienced fewer severe asthma exacerbations (0.69 vs. 0.82) and improved asthma control over time compared to the usual-care group.
- The intervention also led to a reduction in missed days due to asthma, enhancing participants' quality of life and indicating a potential benefit for tailored asthma management strategies in these communities.
Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial.
medRxiv
August 2021
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA (P.B.G., Y.F., Y.L., C.Y., B.B., L.v.d.L., M.P.A., J.G.K., L.C., L.N.C.); the Vaccine Research Center (A.M., B.F., B.C.L., S.O., R.A.K.) and the Biostatistics Research Branch (D.F.), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC (C.M., A.E., M.S.-K., D.C.M.); the Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA (D.B.); the Biomedical Advanced Research and Development Authority, Washington, DC (C.R.H., K.M., L.J., F.C., C.H., R.O.D.); Graduate Group in Biostatistics, University of Berkeley, Berkeley, CA (N.H.); Moderna, Inc., Cambridge, MA (W.D., H.Z., J.M., R.P.); Baylor College of Medicine, Houston, TX (H.M.E.S.); Brigham and Women's Hospital, Boston, MA (L.R.B.); Palm Beach Research Center, West Palm Beach, FL (M.B.); Keystone Vitalink Research, Greenville, SC (L.D.L.C.); University of North Carolina, Chapel Hill, NC (C.G.); Vanderbilt University Medical Center, Nashville, TN (S.K.); Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine and the Grady Health System, Atlanta, GA (C.F.K.); Suncoast Research Group, Miami, FL (M.K.); and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD (K.M.N.).
Background: In the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection.
Methods: Through case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80).
Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
N Engl J Med
March 2021
From the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center (L.C., P.B.G., M.J., S.T.K., A.C.C., E.R., Y.H., K.E.M., J. Hural, M.J.M.E., C.B., S.T., N.E., A.K.R., N.K., D.J.D., J.G.K., G.G.), and the Departments of Global Health, Microbiology, and Medicine, University of Washington (J.I.M.), Seattle; the Department of Surgery and Duke Human Vaccine Institute, Duke University Medical Center (D.C.M.), and FHI 360 (N.S., P.A.), Durham, and the Institute for Global Health and Infectious Disease, University of North Carolina, Chapel Hill (M.S.C.) - both in North Carolina; the National Institute for Communicable Diseases of the National Health Laboratory Service (L.M.) and the Antibody Immunity Research Unit, Faculty of Health Sciences (L.M.), and the Perinatal HIV Research Unit, Faculty of Health Sciences (F.L., E.M.L., S.T.), University of the Witwatersrand, Johannesburg, the Desmond Tutu HIV Centre, Department of Medicine and Institute of Infectious Disease and Molecular Medicine (C.O.), and the Division of Medical Virology (C.W.), University of Cape Town, Cape Town, the School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, Pretoria (S.T.), and the South African Medical Research Council, Tygerberg (G.G.) - all in South Africa; the Department of Medicine, Division of Infectious Diseases, Emory University, Atlanta (S.E.); the University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe (N.M.M., P.G.M.); Servicio de Enfermedades Infecciosas y Tropicales, Hospital Nacional Dos de Mayo (P.G.), Asociación Civil Via Libre (R.C.), Asociación Civil Impacta Salud y Educación (J.R.L.), and Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales, Universidad Nacional Mayor de San Marcos (J.S.), Lima, and Association Civil Selva Amazónica, Clinical Research Site, Iquitos (J. Hinojosa) - both in Peru; the Infectious Diseases Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia (I.F.); the Division of Infectious Diseases, Department of Medicine, Columbia University Irving Medical Center, New York (M.E.S.); Botswana Harvard AIDS Institute, Gaborone, Botswana (J.M.); Brigham and Women's Hospital, Harvard Medical School, Boston (L.R.B.); and the Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Rockville (M.M.G.L.), the Prevention Sciences Program, Division of AIDS (D.N.B.), and the Vaccine Research Center (J.E.L., J.R.M.), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, and Johns Hopkins University School of Medicine, Baltimore (E.P.-M.) - all in Maryland.
Background: Whether a broadly neutralizing antibody (bnAb) can be used to prevent human immunodeficiency virus type 1 (HIV-1) acquisition is unclear.
Methods: We enrolled at-risk cisgender men and transgender persons in the Americas and Europe in the HVTN 704/HPTN 085 trial and at-risk women in sub-Saharan Africa in the HVTN 703/HPTN 081 trial. Participants were randomly assigned to receive, every 8 weeks, infusions of a bnAb (VRC01) at a dose of either 10 or 30 mg per kilogram (low-dose group and high-dose group, respectively) or placebo, for 10 infusions in total.