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1. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive Coronavirus Disease 2019 Treatment Trial (ACTT) as a Test Case.

Author

Ortega-Villa, Ana M, Hynes, Noreen A, Levine, Corri B, Yang, Katherine, Wiley, Zanthia, Jilg, Nikolaus, Wang, Jing, Whitaker, Jennifer A, Colombo, Christopher J, Nayak, Seema U, Kim, Hannah Jang, Iovine, Nicole M, Ince, Dilek, Cohen, Stuart H, Langer, Adam J, Wortham, Jonathan M, Atmar, Robert L, El Sahly, Hana M, Jain, Mamta K, Mehta, Aneesh K, Wolfe, Cameron R, Gomez, Carlos A, Beresnev, Tatiana, Mularski, Richard A, Paules, Catharine I, Kalil, Andre C, Branche, Angela R, Luetkemeyer, Annie, Zingman, Barry S, Voell, Jocelyn, Whitaker, Michael, Harkins, Michelle S, Davey, Richard T, Grossberg, Robert, George, Sarah L, Tapson, Victor, Short, William R, Ghazaryan, Varduhi, Benson, Constance A, Dodd, Lori E, Sweeney, Daniel A, and Tomashek, Kay M

Subjects
ACTT, COVID-19 clinical trials, representation evaluation, Clinical Research, Infectious Diseases, Prevention, Clinical Trials and Supportive Activities, Good Health and Well Being
Abstract

BackgroundClinical trials initiated during emerging infectious disease outbreaks must quickly enroll participants to identify treatments to reduce morbidity and mortality. This may be at odds with enrolling a representative study population, especially when the population affected is undefined.MethodsWe evaluated the utility of the Centers for Disease Control and Prevention's COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), the COVID-19 Case Surveillance System (CCSS), and 2020 United States (US) Census data to determine demographic representation in the 4 stages of the Adaptive COVID-19 Treatment Trial (ACTT). We compared the cumulative proportion of participants by sex, race, ethnicity, and age enrolled at US ACTT sites, with respective 95% confidence intervals, to the reference data in forest plots.ResultsUS ACTT sites enrolled 3509 adults hospitalized with COVID-19. When compared with COVID-NET, ACTT enrolled a similar or higher proportion of Hispanic/Latino and White participants depending on the stage, and a similar proportion of African American participants in all stages. In contrast, ACTT enrolled a higher proportion of these groups when compared with US Census and CCSS. The proportion of participants aged ≥65 years was either similar or lower than COVID-NET and higher than CCSS and the US Census. The proportion of females enrolled in ACTT was lower than the proportion of females in the reference datasets.ConclusionsAlthough surveillance data of hospitalized cases may not be available early in an outbreak, they are a better comparator than US Census data and surveillance of all cases, which may not reflect the population affected and at higher risk of severe disease.

Published
2023

2. Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial

Author

Potter, Gail E, Bonnett, Tyler, Rubenstein, Kevin, Lindholm, David A, Rapaka, Rekha R, Doernberg, Sarah B, Lye, David C, Mularski, Richard A, Hynes, Noreen A, Kline, Susan, Paules, Catharine I, Wolfe, Cameron R, Frank, Maria G, Rouphael, Nadine G, Deye, Gregory A, Sweeney, Daniel A, Colombo, Rhonda E, Davey, Richard T, Mehta, Aneesh K, Whitaker, Jennifer A, Castro, Jose G, Amin, Alpesh N, Colombo, Christopher J, Levine, Corri B, Jain, Mamta K, Maves, Ryan C, Marconi, Vincent C, Grossberg, Robert, Hozayen, Sameh, Burgess, Timothy H, Atmar, Robert L, Ganesan, Anuradha, Gomez, Carlos A, Benson, Constance A, de Castilla, Diego Lopez, Ahuja, Neera, George, Sarah L, Nayak, Seema U, Cohen, Stuart H, Lalani, Tahaniyat, Short, William R, Erdmann, Nathaniel, Tomashek, Kay M, and Tebas, Pablo

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Clinical Research, Rehabilitation, Complementary and Integrative Health, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Humans, Antiviral Agents, Clinical Trials, Phase III as Topic, Dexamethasone, Double-Blind Method, Randomized Controlled Trials as Topic, Treatment Outcome, COVID-19 Drug Treatment, Medical and Health Sciences, General & Internal Medicine, Clinical sciences
Abstract

BackgroundThe COVID-19 standard of care (SOC) evolved rapidly during 2020 and 2021, but its cumulative effect over time is unclear.ObjectiveTo evaluate whether recovery and mortality improved as SOC evolved, using data from ACTT (Adaptive COVID-19 Treatment Trial).DesignACTT is a series of phase 3, randomized, double-blind, placebo-controlled trials that evaluated COVID-19 therapeutics from February 2020 through May 2021. ACTT-1 compared remdesivir plus SOC to placebo plus SOC, and in ACTT-2 and ACTT-3, remdesivir plus SOC was the control group. This post hoc analysis compared recovery and mortality between these comparable sequential cohorts of patients who received remdesivir plus SOC, adjusting for baseline characteristics with propensity score weighting. The analysis was repeated for participants in ACTT-3 and ACTT-4 who received remdesivir plus dexamethasone plus SOC. Trends in SOC that could explain outcome improvements were analyzed. (ClinicalTrials.gov: NCT04280705 [ACTT-1], NCT04401579 [ACTT-2], NCT04492475 [ACTT-3], and NCT04640168 [ACTT-4]).Setting94 hospitals in 10 countries (86% U.S. participants).ParticipantsAdults hospitalized with COVID-19.InterventionSOC.Measurements28-day mortality and recovery.ResultsAlthough outcomes were better in ACTT-2 than in ACTT-1, adjusted hazard ratios (HRs) were close to 1 (HR for recovery, 1.04 [95% CI, 0.92 to 1.17]; HR for mortality, 0.90 [CI, 0.56 to 1.40]). Comparable patients were less likely to be intubated in ACTT-2 than in ACTT-1 (odds ratio, 0.75 [CI, 0.53 to 0.97]), and hydroxychloroquine use decreased. Outcomes improved from ACTT-2 to ACTT-3 (HR for recovery, 1.43 [CI, 1.24 to 1.64]; HR for mortality, 0.45 [CI, 0.21 to 0.97]). Potential explanatory factors (SOC trends, case surges, and variant trends) were similar between ACTT-2 and ACTT-3, except for increased dexamethasone use (11% to 77%). Outcomes were similar in ACTT-3 and ACTT-4. Antibiotic use decreased gradually across all stages.LimitationUnmeasured confounding.ConclusionChanges in patient composition explained improved outcomes from ACTT-1 to ACTT-2 but not from ACTT-2 to ACTT-3, suggesting improved SOC. These results support excluding nonconcurrent controls from analysis of platform trials in rapidly changing therapeutic areas.Primary funding sourceNational Institute of Allergy and Infectious Diseases.

Published
2022

3. Safety and immunogenicity of a delayed booster dose of the rVSVΔG-ZEBOV-GP vaccine for prevention of Ebola virus disease: a multicentre, open-label, phase 2 randomised controlled trial

Author

Davey, Richard T, Jr., Collins, Gary L, Rouphael, Nadine, Poliquin, Guillaume, McConnell, Rosemary, Grubbs, Gabrielle, Moir, Susan L, Langley, Joanne M, Teitelbaum, Marc, Hewlett, Angela L, McLellan, Susan L F, Bhadelia, Nahid, Raabe, Vanessa N, Mulligan, Mark J, Maljkovic Berry, Irina, Dighero-Kemp, Bonnie, Kurtz, Jonathan R, Hensley, Lisa E, Dozier, Nelson C E, Marron, Lindsay C B, DuChene, Alain, Kuhn, Jens H, Brown, Shawn K, Khurana, Surender, Lane, H Clifford, and Neaton, James D

Published
2024
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4. Remdesivir for the prevention of invasive mechanical ventilation or death in COVID-19 - A post-hoc analysis of the Adaptive COVID-19 Treatment Trial-1 Cohort Data

Author

Paules, Catharine I, Gallagher, Shannon K, Rapaka, Rekha R, Davey, Richard T, Doernberg, Sarah B, Grossberg, Robert, Hynes, Noreen A, Ponce, Philip, Short, William R, Voell, Jocelyn, Wang, Jing, Yang, Otto O, Wolfe, Cameron R, Lye, David C, Dodd, Lori E, and Benson, Constance A

Subjects
Clinical Research, Prevention, Clinical Trials and Supportive Activities, Lung, Neurodegenerative, Good Health and Well Being, Adenosine Monophosphate, Alanine, Antiviral Agents, Clinical Trials as Topic, Humans, Respiration, Artificial, SARS-CoV-2, COVID-19 Drug Treatment, COVID-19, remdesivir, ACTT-1, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

This post hoc analysis of the Adaptive Coronavirus Disease 2019 (COVID-19) Treatment Trial-1 (ACTT-1) shows a treatment effect of remdesivir (RDV) on progression to invasive mechanical ventilation (IMV) or death. Additionally, we create a risk profile that better predicts progression than baseline oxygen requirement alone. The highest risk group derives the greatest treatment effect from RDV.

Published
2022

5. Remdesivir for the prevention of invasive mechanical ventilation or death in COVID-19 - A post-hoc analysis of the Adaptive COVID-19 Treatment Trial-1 Cohort Data.

Author

Paules, Catharine I, Gallagher, Shannon K, Rapaka, Rekha R, Davey, Richard T, Doernberg, Sarah B, Grossberg, Robert, Hynes, Noreen A, Ponce, Philip, Short, William R, Voell, Jocelyn, Wang, Jing, Yang, Otto O, Wolfe, Cameron R, Lye, David C, Dodd, Lori E, and Benson, Constance A

Subjects
ACTT-1, COVID-19, Remdesivir, Lung, Prevention, Rare Diseases, Microbiology, Biological Sciences, Medical and Health Sciences
Abstract

This post-hoc analysis of The Adaptive COVID-19 Treatment Trial-1 shows a treatment effect of remdesivir on progression to invasive mechanical ventilation (IMV) or death. Additionally, we create a risk profile that better predicts progression than baseline oxygen requirement alone. The highest risk group derives the greatest treatment effect from RDV.

Published
2021

6. Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19

Author

Kuriakose, Safia, Singh, Kanal, Pau, Alice K, Daar, Eric, Gandhi, Rajesh, Tebas, Pablo, Evans, Laura, Gulick, Roy M, Lane, H Clifford, Masur, Henry, Aberg, Judith A, Adimora, Adaora A, Baker, Jason, Kreuziger, Lisa Baumann, Bedimo, Roger, Belperio, Pamela S, Cantrill, Stephen V, Coopersmith, Craig M, Davis, Susan L, Dzierba, Amy L, Gallagher, John J, Glidden, David V, Grund, Birgit, Hardy, Erica J, Hinkson, Carl, Hughes, Brenna L, Johnson, Steven, Keller, Marla J, Kim, Arthur Y, Lennox, Jeffrey L, Levy, Mitchell M, Li, Jonathan Z, Martin, Greg S, Naggie, Susanna, Pavia, Andrew T, Seam, Nitin, Simpson, Steven Q, Swindells, Susan, Tien, Phyllis, Waghmare, Alpana A, Wilson, Kevin C, Yazdany, Jinoos, Zachariah, Philip, Campbell, Danielle M, Harrison, Carly, Burgess, Timothy, Francis, Joseph, Sheikh, Virginia, Uyeki, Timothy M, Walker, Robert, Brooks, John T, Ortiz, Laura Bosque, Davey, Richard T, Doepel, Laurie K, Eisinger, Robert W, Han, Alison, Higgs, Elizabeth S, Nason, Martha C, Crew, Page, Lerner, Andrea M, Lund, Claire, and Worthington, Christopher

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Health Services, Clinical Research, Generic health relevance, Good Health and Well Being, Advisory Committees, COVID-19, Child, Data Interpretation, Statistical, Drug Approval, Evidence-Based Medicine, Female, Humans, Interprofessional Relations, National Institutes of Health (U.S.), Pandemics, Practice Guidelines as Topic, Pregnancy, SARS-CoV-2, Stakeholder Participation, United States, COVID-19 Drug Treatment, NIH COVID-19 Treatment Guidelines Panel, Medical and Health Sciences, General & Internal Medicine, Clinical sciences
Abstract

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.

Published
2021

7. Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19

Author

Kalil, Andre C, Patterson, Thomas F, Mehta, Aneesh K, Tomashek, Kay M, Wolfe, Cameron R, Ghazaryan, Varduhi, Marconi, Vincent C, Ruiz-Palacios, Guillermo M, Hsieh, Lanny, Kline, Susan, Tapson, Victor, Iovine, Nicole M, Jain, Mamta K, Sweeney, Daniel A, El Sahly, Hana M, Branche, Angela R, Regalado Pineda, Justino, Lye, David C, Sandkovsky, Uriel, Luetkemeyer, Anne F, Cohen, Stuart H, Finberg, Robert W, Jackson, Patrick EH, Taiwo, Babafemi, Paules, Catharine I, Arguinchona, Henry, Erdmann, Nathaniel, Ahuja, Neera, Frank, Maria, Oh, Myoung-Don, Kim, Eu-Suk, Tan, Seow Y, Mularski, Richard A, Nielsen, Henrik, Ponce, Philip O, Taylor, Barbara S, Larson, LuAnn, Rouphael, Nadine G, Saklawi, Youssef, Cantos, Valeria D, Ko, Emily R, Engemann, John J, Amin, Alpesh N, Watanabe, Miki, Billings, Joanne, Elie, Marie-Carmelle, Davey, Richard T, Burgess, Timothy H, Ferreira, Jennifer, Green, Michelle, Makowski, Mat, Cardoso, Anabela, de Bono, Stephanie, Bonnett, Tyler, Proschan, Michael, Deye, Gregory A, Dempsey, Walla, Nayak, Seema U, Dodd, Lori E, and Beigel, John H

Subjects
Rehabilitation, Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adenosine Monophosphate, Adult, Aged, Alanine, Antiviral Agents, Azetidines, COVID-19, Double-Blind Method, Drug Therapy, Combination, Female, Hospital Mortality, Hospitalization, Humans, Janus Kinase Inhibitors, Male, Middle Aged, Oxygen Inhalation Therapy, Purines, Pyrazoles, Respiration, Artificial, Sulfonamides, Treatment Outcome, COVID-19 Drug Treatment, ACTT-2 Study Group Members, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundSevere coronavirus disease 2019 (Covid-19) is associated with dysregulated inflammation. The effects of combination treatment with baricitinib, a Janus kinase inhibitor, plus remdesivir are not known.MethodsWe conducted a double-blind, randomized, placebo-controlled trial evaluating baricitinib plus remdesivir in hospitalized adults with Covid-19. All the patients received remdesivir (≤10 days) and either baricitinib (≤14 days) or placebo (control). The primary outcome was the time to recovery. The key secondary outcome was clinical status at day 15.ResultsA total of 1033 patients underwent randomization (with 515 assigned to combination treatment and 518 to control). Patients receiving baricitinib had a median time to recovery of 7 days (95% confidence interval [CI], 6 to 8), as compared with 8 days (95% CI, 7 to 9) with control (rate ratio for recovery, 1.16; 95% CI, 1.01 to 1.32; P = 0.03), and a 30% higher odds of improvement in clinical status at day 15 (odds ratio, 1.3; 95% CI, 1.0 to 1.6). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination treatment and 18 days with control (rate ratio for recovery, 1.51; 95% CI, 1.10 to 2.08). The 28-day mortality was 5.1% in the combination group and 7.8% in the control group (hazard ratio for death, 0.65; 95% CI, 0.39 to 1.09). Serious adverse events were less frequent in the combination group than in the control group (16.0% vs. 21.0%; difference, -5.0 percentage points; 95% CI, -9.8 to -0.3; P = 0.03), as were new infections (5.9% vs. 11.2%; difference, -5.3 percentage points; 95% CI, -8.7 to -1.9; P = 0.003).ConclusionsBaricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation. The combination was associated with fewer serious adverse events. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04401579.).

Published
2021

8. Detection of Nucleocapsid Antibody to SARS-CoV-2 is More Sensitive than Antibody to Spike Protein in COVID-19 Patients

Author

Burbelo, Peter D, Riedo, Francis X, Morishima, Chihiro, Rawlings, Stephen, Smith, Davey, Das, Sanchita, Strich, Jeffrey R, Chertow, Daniel S, Davey, Richard T, and Cohen, Jeffrey I

Subjects
Pneumonia, Lung, Pneumonia & Influenza, Infectious Diseases, Biodefense, Emerging Infectious Diseases, Biotechnology, Vaccine Related, Prevention, Infection, Good Health and Well Being, Adult, Antibodies, Viral, Betacoronavirus, COVID-19, COVID-19 Testing, Clinical Laboratory Techniques, Coronavirus Infections, Coronavirus Nucleocapsid Proteins, Female, Hot Temperature, Humans, Immunocompetence, Immunocompromised Host, Immunoprecipitation, Luciferases, Male, Middle Aged, Nucleocapsid Proteins, Pandemics, Phosphoproteins, Pneumonia, Viral, Retrospective Studies, SARS-CoV-2, Sensitivity and Specificity, Spike Glycoprotein, Coronavirus, Time Factors, coronavirus, serology, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is associated with respiratory-related disease and death. Assays to detect virus-specific antibodies are important to understand the prevalence of infection and the course of the immune response.MethodsQuantitative measurements of plasma or serum antibodies to the nucleocapsid and spike proteins were analyzed using luciferase immunoprecipitation system assays in 100 cross-sectional or longitudinal samples from patients with SARS-CoV-2 infection. A subset of samples was tested both with and without heat inactivation.ResultsAt >14 days after symptom onset, antibodies against SARS-CoV-2 nucleocapsid protein showed 100% sensitivity and 100% specificity, whereas antibodies to spike protein were detected with 91% sensitivity and 100% specificity. Neither antibody levels nor the rate of seropositivity were significantly reduced by heat inactivation of samples. Analysis of daily samples from 6 patients with COVID-19 showed anti-nucleocapsid and spike protein antibodies appearing between days 8 and 14 after initial symptoms. Immunocompromised patients generally had a delayed antibody response to SARS-CoV-2, compared with immunocompetent patients.ConclusionsAntibody to the nucleocapsid protein of SARS-CoV-2 is more sensitive than spike protein antibody for detecting early infection. Analyzing heat-inactivated samples with a luciferase immunoprecipitation system assay is a safe and sensitive method for detecting SARS-CoV-2 antibodies.

Published
2020

9. Sensitivity in Detection of Antibodies to Nucleocapsid and Spike Proteins of Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Coronavirus Disease 2019.

Author

Burbelo, Peter D, Riedo, Francis X, Morishima, Chihiro, Rawlings, Stephen, Smith, Davey, Das, Sanchita, Strich, Jeffrey R, Chertow, Daniel S, Davey, Richard T, and Cohen, Jeffrey I

Subjects
Humans, Pneumonia, Viral, Coronavirus Infections, Luciferases, Phosphoproteins, Nucleocapsid Proteins, Antibodies, Viral, Clinical Laboratory Techniques, Sensitivity and Specificity, Retrospective Studies, Immunoprecipitation, Immunocompetence, Immunocompromised Host, Time Factors, Adult, Middle Aged, Female, Male, Hot Temperature, Pandemics, Spike Glycoprotein, Coronavirus, Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Testing, Coronavirus Nucleocapsid Proteins, coronavirus, serology, Antibodies, Viral, Pneumonia, Spike Glycoprotein, Coronavirus, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), is associated with respiratory-related disease and death. Assays to detect virus-specific antibodies are important to understand the prevalence of infection and the course of the immune response.MethodsQuantitative measurements of plasma or serum antibodies to the nucleocapsid and spike proteins were analyzed using luciferase immunoprecipitation system assays in 100 cross-sectional or longitudinal samples from patients with SARS-CoV-2 infection. A subset of samples was tested both with and without heat inactivation.ResultsAt >14 days after symptom onset, antibodies against SARS-CoV-2 nucleocapsid protein showed 100% sensitivity and 100% specificity, whereas antibodies to spike protein were detected with 91% sensitivity and 100% specificity. Neither antibody levels nor the rate of seropositivity were significantly reduced by heat inactivation of samples. Analysis of daily samples from 6 patients with COVID-19 showed anti-nucleocapsid and spike protein antibodies appearing between days 8 and 14 after initial symptoms. Immunocompromised patients generally had a delayed antibody response to SARS-CoV-2, compared with immunocompetent patients.ConclusionsAntibody to the nucleocapsid protein of SARS-CoV-2 is more sensitive than spike protein antibody for detecting early infection. Analyzing heat-inactivated samples with a luciferase immunoprecipitation system assay is a safe and sensitive method for detecting SARS-CoV-2 antibodies.

Published
2020

10. Lassa Virus Infection: a Summary for Clinicians

Author

Beitscher, Adam, Bhadelia, Nahid, Brett-Major, David, Cieslak, Theodore J, Davey, Richard T, Evans, Jared D, Frank, Maria G, Iwen, Peter, Kortepeter, Mark G, Levine, Corri, McLellan, Susan, Mehta, Aneesh K, Sauer, Lauren, Shenoy, Erica S, Zachary, Kimon, Raabe, Vanessa, and Evans, Jared D.

Published
2022
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11. South American Hemorrhagic Fevers: A summary for clinicians

Author

Beitscher, Adam, Bhadelia, Nahid, Cieslak, Theodore J., Davey, Richard T., Dierberg, Kerry, Evans, Jared D., Frank, Maria G., Grein, Jonathan, Kortepeter, Mark G., Kraft, Colleen S., Kratochvil, Chris J., Martins, Karen, McLellan, Susan, Mehta, Aneesh K., Raabe, Vanessa, Risi, George, Sauer, Lauren, Shenoy, Erica S., Uyeki, Tim, and Webb, Camille M.

Published
2021
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12. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author

Beigel, John H, Tebas, Pablo, Elie-Turenne, Marie-Carmelle, Bajwa, Ednan, Bell, Todd E, Cairns, Charles B, Shoham, Shmuel, Deville, Jaime G, Feucht, Eric, Feinberg, Judith, Luke, Thomas, Raviprakash, Kanakatte, Danko, Janine, O'Neil, Dorothy, Metcalf, Julia A, King, Karen, Burgess, Timothy H, Aga, Evgenia, Lane, H Clifford, Hughes, Michael D, Davey, Richard T, Team, IRC002 Study, Quinn, Joseph, Jiang, Yan, Hoelle, Robyn, Iovine, Nicole, Wills, Robert Shawn, Pata, Socorro, Huggins, Monique, Manukian, Belinda, Holland, Carrie, Brait, Kelsey, Hunt, Taylor, Stowell, Christopher, Slater, Amy, Townsends, Mary, Quackenbush, Eugenia B, Park, Yara A, Jordan, Paul Gaither, Blanchet, Cherie, Chronowski, Kevin, Alvarez, Kathleen, Ostrander, Darin, Woessner, Terry, Thoman, Sandra, Lin, James, Ziman, Alyssa, Shankar, Kavita, Blok, Tom, Batts, Don, Beck, Bob, Massey, Gail, Bradley, Carol, Carey, Patricia, Baer, Jenifer, Whitehead, Eva Moore, Kohrs, Sharon, Giulitto, Robert, Schofield, Christina, Fairchok, Mary, Chambers, Susan, Baker, Cindy, RN, Parker, Michelle, Harshbarger, Marta, Nguyen, M Hong, Carey, Mary Ellen, Paronish, Julie, Cornell, Frank, Cramer, Jim, Pakstis, Diana Lynn, Ison, Michael G, Wunderink, Richard, Glesby, Marshall, Ham, Kirsis, Hughes, Valery, Cushing, Melissa, Goss, Cheryl, Grenade, Joanne, Park, Pauline K, Napolitano, Lena M, Raghavendran, Krishnan, Hyzy, Robert C, Davenport, Robertson, Brierley, Kristin, Downs, Theresa, Gong, Michelle Ng, Uehlinger, Joan, Lin, Michael, Fritsche, Janice, and Green, Tondria

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Health Services, Clinical Research, Influenza, Pneumonia & Influenza, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Aged, Blood Component Transfusion, Case-Control Studies, Female, Humans, Influenza, Human, Kaplan-Meier Estimate, Length of Stay, Male, Middle Aged, Plasma, Respiration, Artificial, Treatment Outcome, IRC002 Study Team, Public Health and Health Services, Other Medical and Health Sciences, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundInfluenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza.MethodsIn this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480.FindingsBetween Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days [0-14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients).InterpretationAlthough there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention.FundingNational Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Published
2017

14. Markers of inflammation and activation of coagulation are associated with anaemia in antiretroviral-treated HIV disease

Author

Borges, Álvaro H, Weitz, Jeffrey I, Collins, Gary, Baker, Jason V, Lévy, Yves, Davey, Richard T, Phillips, Andrew N, Neaton, James D, Lundgren, Jens D, and Deeks, Steven G

Subjects
HIV/AIDS, Infectious Diseases, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adult, Anemia, Anti-Retroviral Agents, Blood Coagulation Disorders, C-Reactive Protein, CD4 Lymphocyte Count, Cross-Sectional Studies, Female, Fibrin Fibrinogen Degradation Products, HIV Infections, Hemoglobins, Humans, Inflammation, Interleukin-6, Male, Plasma, Viral Load, anaemia, coagulation, C-reactive protein, D-dimer, HIV, interleukin-6, inflammation, INSIGHT SILCAAT Scientific Committee, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology
Abstract

ObjectiveThe objective of this study is to determine the relationship between inflammatory interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] and coagulation (D-dimer) biomarkers and the presence and type of anaemia among HIV-positive individuals.DesignA cross-sectional study.MethodsCombination antiretroviral therapy (cART)-treated adults participating in an international HIV trial with haemoglobin and mean corpuscular volume (MCV) measurements at entry were categorized by presence of anaemia (haemoglobin ≤14 g/dl in men and ≤12 g/dl in women) and, for those with anaemia, by type [microcytic (MCV 100 fl)]. We analysed the association between inflammation (IL-6 and hsCRP) and coagulation (D-dimer) and haemoglobin, controlling for demographics (age, race and sex), BMI, HIV plasma RNA levels, CD4⁺ T-cell counts (nadir and baseline), Karnofsky score, previous AIDS diagnosis, hepatitis B/C coinfection and use of zidovudine.ResultsAmong 1410 participants, 313 (22.2%) had anaemia. Of these, 4.1, 27.2 and 68.7% had microcytic, normocytic and macrocytic anaemia, respectively. When compared with participants with normal haemoglobin values, those with anaemia were more likely to be older, black, male and on zidovudine. They also had lower baseline CD4⁺ T-cell counts and lower Karnofsky scores. Adjusted relative odds of anaemia per two-fold higher biomarker levels were 1.22 (P = 0.007) for IL-6, 0.99 for hsCRP (P = 0.86) and 1.35 (P

Published
2014

16. Short-Cycle Structured Intermittent Treatment of Chronic HIV Infection with Highly Active Antiretroviral Therapy: Effects on Virologic, Immunologic, and Toxicity Parameters

Author

Dybul, Mark, Chun, Tae-Wook, Yoder, Christian, Hidalgo, Bertha, Belson, Michael, Hertogs, Kurt, Larder, Brendan, Dewar, Robin L., Fox, Cecil H., Hallahan, Claire W., Justement, J. Shawn, Migueles, Stephen A., Metcalf, Julia A., Davey, Richard T., Daucher, Marybeth, Pandya, Punita, Baseler, Michael, Ward, Douglas J., and Fauci, Anthony S.

Published
2001

18. HIV-1 and T Cell Dynamics after Interruption of Highly Active Antiretroviral Therapy (HAART) in Patients with a History of Sustained Viral Suppression

Author

Davey,, Richard T., Bhat, Niranjan, Yoder, Christian, Chun, Tae-Wook, Metcalf, Julia A., Dewar, Robin, Natarajan, Ven, Lempicki, Richard A., Adelsberger, Joseph W., Miller, Kirk D., Kovacs, Joseph A., Polis, Michael A., Walker, Robert E., Falloon, Judith, Masur, Henry, Gee, Dennis, Baseler, Michael, Dimitrov, Dimiter S., Fauci, Anthony S., and Lane, H. Clifford

Published
1999

19. Evaluating Demographic Representation in Clinical Trials: Use of the Adaptive COVID-19 Treatment Trial (ACTT) as a Test Case

Author

Ortega-Villa, Ana M, primary, Hynes, Noreen A, additional, Levine, Corri B, additional, Yang, Katherine, additional, Wiley, Zanthia, additional, Jilg, Nikolaus, additional, Wang, Jing, additional, Whitaker, Jennifer A, additional, Colombo, Christopher J, additional, Nayak, Seema U, additional, Kim, Hannah Jang, additional, Iovine, Nicole M, additional, Ince, Dilek, additional, Cohen, Stuart H, additional, Langer, Adam J, additional, Wortham, Jonathan M, additional, Atmar, Robert L, additional, El Sahly, Hana M, additional, Jain, Mamta K, additional, Mehta, Aneesh K, additional, Wolfe, Cameron R, additional, Gomez, Carlos A, additional, Beresnev, Tatiana, additional, Mularski, Richard A, additional, Paules, Catharine I, additional, Kalil, Andre C, additional, Branche, Angela R, additional, Luetkemeyer, Annie, additional, Zingman, Barry S, additional, Voell, Jocelyn, additional, Whitaker, Michael, additional, Harkins, Michelle S, additional, Davey, Richard T, additional, Grossberg, Robert, additional, George, Sarah L, additional, Tapson, Victor, additional, Short, William R, additional, Ghazaryan, Varduhi, additional, Benson, Constance A, additional, Dodd, Lori E, additional, Sweeney, Daniel A, additional, and Tomashek, Kay M, additional

Published
2023
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20. Comparison of the Outcomes of Individuals With Medically Attended Influenza A and B Virus Infections Enrolled in 2 International Cohort Studies Over a 6-Year Period: 2009–2015

Author

Dwyer, Dominic E, Lynfield, Ruth, Losso, Marcelo H, Davey, Richard T, Cozzi-Lepri, Alessandro, Wentworth, Deborah, Uyeki, Timothy M, Gordin, Fred, Angus, Brian, Qvist, Tavs, Emery, Sean, Lundgren, Jens, Neaton, James D, Aagaard, Bitten, Borges, Álvaro H D, Cozzi-Lepri, Alessandro, Eid, Marius, Jansson, Per O, Jeppesen, Marianne, Joensen, Zillah Maria, Pedersen, Ruth Kjærgaard, Lundgren, Jens, Nielsen, Birgit Riis, Pearson, Mary, Peters, Lars, Qvist, Tavs, Angus, Brian, Babiker, Abdel, Bennett, Rachel, Braimah, Nafisah, Collaco-Moraes, Yolanda, Cursley, Adam, Hudson, Fleur, Pett, Sarah, Russell, Charlotte, Webb, Helen, Carey, Dianne, Courtney-Rodgers, David, Emery, Sean, Shaw, Pamela, Gordin, Fred, Sanchez, Adriana, Standridge, Barbara, Vjecha, Michael, Brekke, Kate, Campbell, Megan, Denning, Eileen, DuChene, Alain, Engen, Nicole, George, Michelle, Harrison, Merrie, Neaton, James D, Nelson, Ray, Quan, Siu-Fun, Schultz, Terri, Wentworth, Deborah, Baxter, John, Brown, Shawn, Hoover, Marie, Beigel, John, Davey, Richard T, Jr., Dewar, Robin, Gover, Erin, McConnell, Rose, Metcalf, Julia, Natarajan, Ven, Rehman, Tauseef, Voell, Jocelyn, Dwyer, Dominic E, Kok, Jen, Uyeki, Timothy M, Munroe, David, Aguila, Damian, Alzogaray, Maria Fernanda, Ballesteros, Maria Fernanda, Barcan, Laura, Barcelona, Laura, Belloso, Waldo, Berdiñas, Veronica, Bonvehi, Pablo, Caeiro, Juan Pablo, Cisneros, Veronica, Crinejo, Ana, David, Daniel, Doldan, Luz, Ebenrstejin, Juan, Lipari, Flavio, Lopardo, Ana, Lopardo, Gustavo, Losso, Marcelo, Lucchetti, Pablo, Lupo, Sergio, Macias, Laura Moreno, de Tesco, Alejandra Moricz, Mykietiuk, Analia, Nannini, Estaban, Nieto, Gabriel, Nieto, Laura, Peroni, Luciana, Retta, Ignacio, Rodriguez, Patricia, Sanchez, Marisa, Sanchez, Pablo, de Paz Sierra, Mariana, Tavella, Silvina, Temporiti, Elena, Trape, Liliana, Vieni, Ines, Warley, Eduardo, Yahni, Diego, Zarate, Abel Humberto, Avihingsanon, Anchalee, Charoentonpuban, Kanlaya, Chetchotisakd, Ploenchan, Kaewon, Peeraporn, Laopraynak, Naphassanant, Manosuthi, Weerawat, Pussadee, Kanitta, Putcharoen, Opass, Ruxrungtham, Kiat, Suwanpimonkul, Gompol, Ubolyam, Sasiwimol, Arduino, Roberto, Atkinson, Barbara, Aulicino, Taryn M, Baker, Jason V, Bardascino, Cindy, Bass, Caitlin, Baxter, John D, Beilke, Mark, Bentley, Beverly D, Lee Bertrand, Mary, Brown, Ann B, Carbonneau, June, Cindrich, Richard, Coburn, Patty, Cohen, Calvin J, Clark, Linda, Cummins, Shirley, Dassow, Paul, DeHovitz, Jack A, Dharan, Nila J, Faber, Leslie, Farrough, Marti, Freiberg, Matthew, Gardner, Edward, Jo Garrett, Kimberly, Geisler, Christiane, Glesby, Marshall, Green, Julia, Grenade, Joanne, Gunderson, Edie, Gunter, John, Ham, Kirsis, Holman, Susan, Hughes, Valery, Hurt, Christopher, Johnson, Mary, Koerbel, Glory, Koletar, Susan, Lan, Audrey, MacArthur, Rodger, Marcus, Cheryl, Markowitz, Norm, Martinez, Maria Laura, McLaughlin, Karen, Nahra, Raquel, Nettles, Mary Jane, Nixon, Daniel, Novak, Richard, Nuffer, Kathleen, Olivet, Hannah B, Omotosho, Bola, Paez, Armando P, Paez-Quinde, Marta, Parker, Sonija, Patil, Namrata, Polenakovik, Hari, Powell, Sandra, Prosser, Rachel A, Reilly, Nancy A, Riska, Paul F, Rizza, Stacey, Schooley, Robert, Schwarber, Marla, Scott, James, Simon, Gary L, Sivoravong, Jon, Skiest, Daniel J, Solorzano, Clemencia, Sondengam, Rita, Swanson, Nicole, Tedaldi, Ellen, Temesgen, Zelalem, Thomas, Doug, Thron, Bill, Traverse, Colleen, Uddin, David E, Uslan, Daniel Z, Vasco, Marina, Vaughan, William M, Vecino, Isabel, Wade, Barbara, Walker, Catrice, Watson, Kathy, Watson, Vicky, Wohl, David, Wolfe, Cameron R, Andry, Leslie, Bielen, Mireille, Clumeck, Nathan, Florence, Eric, Kabeya, Kabamba, Sagaer, Jolanthe, Weckx, Jozef, Anagnostou, Olga, Antoniadou, Anastasia, Daikos, George, Gioukari, Vicky, Kalomenidis, Ioannis, Kantzanou, Maria, Koratzanis, Georgios, Koulouris, Nikolaos, Maltezos, Efstratios, Metallidis, Symeon, Polixronopoulos, Vlassis, Sambatakou, Helen, Skoutelis, Athanasios, Touloumi, Giota, Vasilopoulos, Nikolaos, Bloch, Mark, Cunningham, Nicky, Dwyer, Dominic E, Edwards, Sian, Elliott, Julian, Garlick, Jill, Habel, Philip, Kilkenny, Fiona, Lau, Helen, MacRae, Karen, McBride, John, Moore, Richard, Prone, Isabel, Ram, Ristila, Richmond, Sue, Roth, Norm, Meng Soo, Tuck, Jo-Anne, Thompson, Vincent, Trina, Vlakahis, Emanuel, Woolstencroft, Rachel, Chadwick, David, Clarke, Tristan, Democratis, Jane, Dockrell, David, Heyderman, Robert, Jeffs, Ben, Kutter, Stefan, Llewelyn, Martin, Minton, Jane, Newport, Melanie, Price, Ashley, Benites, Carlos, Castillo, Raul, Chinchay, Romina, Cornelio, Eva, Guevara, Maria, Gutierrez, Luis, Hidalgo, Jose, La Rosa, Alberto, Pinedo, Yvett, Saenz, Maria, Vega, Juan, Baadegaard, Bente, Bach, Karen, Collins, Philippa, Gerstoft, Jan, Hergens, Lene, Jensen, Lene Pors, Joensen, Zillah Maria, Kronborg, Gitte, Loftheim, Iben Rose, Nielsen, Henrik, Oestergaard, Lars, Pedersen, Court, Stauning Pedersen, Jens Aage, Yehdego, Yordanos, Bergmann, Frank, Boesecke, Christoph, Bogner, Johannes R, Brockmeyer, Norbert, Czaja-Harder, Christine, Draenert, Rika, Fätkenheuer, Gerd, Klinker, Hartwig, Kümmerle, Tim, Lehmann, Clara, Müller, Vera, Plettenberg, Andreas, Rockstroh, Jürgen, Schlabe, Stefan, E Schmidt, Wolfgang, Schürmann, Dirk, Schüttfort, Gundolf, Seybold, Ulrich, Stephan, Christoph, Stoehr, Albrecht, Tillmann, Klaus, Wiebecke, Susanne, Wolf, Timo, Arribas, Jose, Carbone, Javier, Fernández Cruz, Eduardo, Dalmau, David, Estrada, Vincente, Herrero, Patricia, Knobel, Hernando, López, Paco, Montejano, Rocío, Sans Moreno, José, Ramón Paño, José, Portas, Begoña, Rodrigo, Maria, Romero, Pilar, Sánchez-Sendín, Domingo, Soriano, Vincente, Bakowska, Elzbieta, Horban, Andrzej Jerzy, Knysz, Brygida, Kowalska, Karolina Pyziak, Zubkiewicz-Zarebska, Anna, Kase, Kerstin, Mülle, Helen, Zilmer, Kai, Allendes, Gladys, Flores, Jimena, Northland, Rebeka, Perez, Carlos, Velasco, Isabel, Wolff, Marcelo, Chu, Man-Yee, Wu, Tak-chiu, Burgmann, Heinz, Tobudic, Selma, Imahashi, Mayumi, Imamura, Junji, Iwatani, Yasumasa, Kogure, Ayumi, Nakahata, Masashi, Sugiura, Wataru, Yokomaku, Yoshiyuki, and Maagaard, Anne

Published
2017
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21. Increased Indoleamine-2,3-Dioxygenase Activity Is Associated With Poor Clinical Outcome in Adults Hospitalized With Influenza in the INSIGHT FLU003Plus Study

Author

Pett, Sarah L, Kunisaki, Ken M, Wentworth, Deborah, Griffin, Timothy J, Kalomenidis, Ioannis, Nahra, Raquel, Montejano Sanchez, Rocio, Hodgson, Shane W, Ruxrungtham, Kiat, Dwyer, Dominic, Davey, Richard T, Wendt, Chris H, Lundgren, J, Jansson, P, Pearson, M, Aagaard, B, Hudson, F, Bennet, R, Pacciarini, F, Angus, B, Paton, N, Collaco Moraes, Y, Cooper, D, Pett, S, Emery, S, Courtney-Rogers, D, Robson, R, Gordin, F, Sanchez, A, Standridge, B, Vjecha, M, Moricz, A, Delfino, M, Belloso, W, Losso, M, Tillmann, K, Touloumi, G, Gioukari, V, Anagnostou, O, La Rosa, A, Saenz, M J, Lopez, P, Herrero, P, Portas, B, Avihingsanon, A, Ruxrungtham, K, Kaewon, P, Ubolyam, S, Brekke, K, Campbell, M, Denning, E, DuChene, A, Engen, N, George, M, Harrison, M, Neaton, J D, Nelson, R, Quan, S F, Schultz, T, Wentworth, D, Baxter, J, Brown, S, Hoover, M, Beigel, J, Davey, R T, Jr., Dewar, R, Gover, E, McConnell, R, Metcalf, J, Natarajan, V, Rehman, T, Voell, J, Dwyer, D E, Kok, J, Uyeki, T, Munroe, D, Paez, A, Bertrand, M, Temesgen, Z, Rizza, S, Wolfe, C, Carbonneau, J, Novak, R, Schwarber, M, Polenakovik, H, Clark, L, Patil, N, Riska, P, Omotosho, J, Faber, L, Markowitz, N, Glesby, M, Ham, K, Parenti, D, Simon, G, Baxter, J, Coburn, P, Freiberg, M, Koerbel, G, Dharan, N, Paez-Quinde, M, Gunter, J, Beilke, M, Lu, Z, Gunderson, E, Baker, J, Koletar, S, Harber, H, Hurt, C, Marcus, C, Allen, M, Cummins, S, Uslan, D, Bonam, T, Paez, A, Santiago, F, States, D, Gardner, E, DeHovitz, J, Holman, S, Watson, V, Nixon, D, Dwyer, D, Kabir, M, Pett, S, Kilkenny, F, Elliott, J, Garlick, J, McBride, J, Richmond, S, Barcan, L, Sanchez, M, Lopardo, G, Barcelona, L, Bonvehi, P, Temporiti, E R, Losso, M, Macias, L, Laplume, H, Daciuk, L, Warley, E, Tavella, S, Fernandez Cruz, E, Paño, J, Estrada, V, Lopetegui, P, Gimenez Julvez, T, Ryan, P, Sanz Moreno, J, Knobel, H, Soriano, V, Dalmau, D, Dockrell, D, Angus, B, Price, D, Newport, M, Chadwick, D, Østergaard, L, Yehdego, Y, Pedersen, C, Hergens, L, Joensen, Z, Aagaard, B, Kronborg, G, Collins, P, Nielsen, H, Gerstoft, J, Baadegaard, B, Koulouris, N, Antoniadou, A, Protopappas, K, Polixronopoulos, V, Diamantea, F, Sambatakou, H, Mariolis, I, Vassilopoulos, N, Gerogiannis, A, Pinedo Ramirez, Y, Cornelio Mauricio, E, Vega Bazalar, J, Castillo Cordova, R, Fãtkenhuerer, G, Thomas, E, Bergmann, F, Fõllmer, U, Rockstroh, J, Englehardt, A, Stephan, C, Thomas, E, Bogner, J, Brockmeyer, N, Klinker, H, Chetchotisakd, P, Jumpimai, T, Avihingsanon, A, Ruxrungtham, K, Clumeck, N, Kameya, K, Chu, M Y, Wu, T C, Horban, A, Bakowska, E, Burgmann, H, Tobudic, S, Maagaard, A, Wolff, M, and Allendes, G

Published
2018
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23. Human antibody repertoire after VSV-Ebola vaccination identifies novel targets and virus-neutralizing IgM antibodies

Author

Khurana, Surender, Fuentes, Sandra, Coyle, Elizabeth M, Ravichandran, Supriya, Davey, Richard T, Jr, and Beigel, John H

Subjects
Vaccines -- Research, Ebola hemorrhagic fever -- Prevention -- Research, Immunoglobulin M -- Research, Biological sciences, Health
Abstract

Development of an effective vaccine against Ebola virus is of high priority. However, knowledge about potential correlates of protection and the durability of immune response after vaccination is limited. Here, we elucidate the human antibody repertoire after administration of vesicular stomatitis virus (VSV)-Ebola vaccine at 3 million, 20 million and 100 million plaque-forming units (PFU) and homologous VSV-Ebola vaccine boost in healthy adult volunteers. Whole genome-fragment phage display libraries, expressing linear and conformational epitopes of Ebola glycoprotein (GP), showed higher diversity of antibody epitopes in individuals vaccinated with 20 million PFU than in those vaccinated with 3 million or 100 million PFU. Surface plasmon resonance kinetics showed higher levels of GP-binding antibodies after a single vaccination with 20 million or 100 million PFU than with 3 million PFU, and these correlated strongly with neutralization titers. A second vaccination did not boost antibody or virus neutralization titers, which declined rapidly, and induced only minimal antibody affinity maturation. Isotype analysis revealed a predominant IgM response even after the second vaccination, which contributed substantially to virus neutralization in vitro. These findings may help identify new vaccine targets and aid development and evaluation of effective countermeasures against Ebola., Author(s): Surender Khurana (corresponding author) [1]; Sandra Fuentes [1]; Elizabeth M Coyle [1]; Supriya Ravichandran [1]; Richard T Davey, Jr [2]; John H Beigel [3] The recent 2014 epidemic of [...]

Published
2016
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25. Remdesivir for the Prevention of Invasive Mechanical Ventilation or Death in Coronavirus Disease 2019 (COVID-19): A Post Hoc Analysis of the Adaptive COVID-19 Treatment Trial-1 Cohort Data

Author

Paules, Catharine I, Gallagher, Shannon K, Rapaka, Rekha R, Davey, Richard T, Doernberg, Sarah B, Grossberg, Robert, Hynes, Noreen A, Ponce, Philip O, Short, William R, Voell, Jocelyn, Wang, Jing, Yang, Otto O, Wolfe, Cameron R, Lye, David C, Dodd, Lori E, and Benson, Constance A

Subjects
Alanine, SARS-CoV-2, Respiration, Prevention, COVID-19, remdesivir, Biological Sciences, Antiviral Agents, Microbiology, Medical and Health Sciences, Adenosine Monophosphate, Rare Diseases, Artificial, ACTT-1, Humans, Lung
Abstract

This post hoc analysis of the Adaptive Coronavirus Disease 2019 (COVID-19) Treatment Trial-1 (ACTT-1) shows a treatment effect of remdesivir (RDV) on progression to invasive mechanical ventilation (IMV) or death. Additionally, we create a risk profile that better predicts progression than baseline oxygen requirement alone. The highest risk group derives the greatest treatment effect from RDV.

Published
2022

26. Use of Ebola Vaccine: Expansion of Recommendations of the Advisory Committee on Immunization Practices To Include Two Additional Populations--United States, 2021

Author

Malenfant, Jason H., Joyce, Allison, Choi, Mary J., Cossaboom, Caitlin M., Whitesell, Amy N., Harcourt, Brian H., Atmar, Robert L., Villanueva, Julie M., Bell, Beth P., Hahn, Christine, Loehr, Jamie, Davey, Richard T., Sprecher, Armand, Kraft, Colleen S., Shoemaker, Trevor, Montgomery, Joel M., Helfand, Rita, Damon, Inger K., Frey, Sharon E., and Chen, Wilbur H.

Subjects
Merck & Company Inc. -- International economic relations, Vaccination -- Usage -- Health aspects, Ebola virus infections -- Prevention, Infection -- Prevention, Drug approval -- Health aspects -- Usage, Vaccines -- Usage, Medical personnel -- Usage -- Health aspects, Pharmaceutical industry -- International economic relations, Ebola virus -- Health aspects -- Usage, Virus diseases -- Prevention, Health, Ervebo (Vaccine) -- Health aspects -- Usage
Abstract

Introduction On December 19, 2019, the Food and Drug Administration (FDA) approved rVSVAG-ZEBOV-GP Ebola vaccine (ERVEBO, Merck) for the prevention of Ebola virus disease (EVD) caused by infection with Ebola [...]

Published
2022

29. A Proof-of-Concept Study of Short-Cycle Intermittent Antiretroviral Therapy with a Once-Daily Regimen of Didanosine, Lamivudine, and Efavirenz for the Treatment of Chronic HIV Infection

Author

Dybul, Mark, Nies-Kraske, Elizabeth, Dewar, Robin, Maldarelli, Frank, Hallahan, Claire W., Daucher, Marybeth, Piscitelli, Stephen C., Ehler, Linda, Weigand, Ann, Palmer, Sarah, Metcalf, Julia A., Davey, Richard T., Kress, Diane M. Rock, Powers, April, Beck, Ingrid, Frenkel, Lisa, Baseler, Michael, Coffin, John, and Fauci, Anthony S.

Published
2004

31. Long-Cycle Structured Intermittent versus Continuous Highly Active Antiretroviral Therapy for the Treatment of Chronic Infection with Human Immunodeficiency Virus: Effects on Drug Toxicity and on Immunologic and Virologic Parameters

Author

Dybul, Mark, Nies-Kraske, Elizabeth, Gaucher, Marybeth, Hertogs, Kurt, Hallahan, Claire W., Csako, Gyorgy, Yoder, Christian, Ehler, Linda, Sklar, Peter A., Belson, Michael, Hidalgo, Bertha, Metcalf, Julia A., Davey, Richard T., Rock Kress, Diane M., Powers, April, and Fauci, Anthony S.

Published
2003

35. A Randomized, Controlled, Phase II Trial Comparing Escalating Doses of Subcutaneous Interleukin-2 plus Antiretrovirals versus Antiretrovirals Alone in Human Immunodeficiency Virus-Infected Patients with CD4⁺ Cell Counts ⩾350/mm³

Author

Vanguard Study Group, Losso, Marcelo H., Belloso, Waldo H., Emery, Sean, Benetucci, Jorge A., Cahn, Pedro E., Lasala, Maria C., Lopardo, Gustavo, Salomon, Horacio, Saracco, Monica, Nelson, Eileen, Law, Matthew G., Davey, Richard T., Allende, Maria C., and Lane, H. Clifford

Published
2000

39. Plasma Viremia as a Sensitive Indicator of the Antiretroviral Activity of L-697,661

Author

Davey,, Richard T., Dewar, Robin L., Reed, George F., Vasudevachari, M. B., Polis, Michael A., Kovacs, Joseph A., Falloon, Judith, Walker, Robert E., Masur, Henry, Haneiwich, Susan E., O'Neill, Donna G., Decker, Marilyn R., Metcalf, Julia A., Deloria, Maria A., Laskin, Oscar L., Salzman, Norman, and Lane, H. Clifford

Published
1993

46. High-throughput, single-copy sequencing reveals SARS-CoV-2 spike variants coincident with mounting humoral immunity during acute COVID-19

Author

Ko, Sung Hee, primary, Bayat Mokhtari, Elham, additional, Mudvari, Prakriti, additional, Stein, Sydney, additional, Stringham, Christopher D., additional, Wagner, Danielle, additional, Ramelli, Sabrina, additional, Ramos-Benitez, Marcos J., additional, Strich, Jeffrey R., additional, Davey, Richard T., additional, Zhou, Tongqing, additional, Misasi, John, additional, Kwong, Peter D., additional, Chertow, Daniel S., additional, Sullivan, Nancy J., additional, and Boritz, Eli A., additional

Published
2021
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47. South American Hemorrhagic Fevers: A summary for clinicians

Author

Frank, Maria G., primary, Beitscher, Adam, additional, Webb, Camille M., additional, Raabe, Vanessa, additional, Bhadelia, Nahid, additional, Cieslak, Theodore J., additional, Davey, Richard T., additional, Dierberg, Kerry, additional, Evans, Jared D., additional, Frank, Maria G., additional, Grein, Jonathan, additional, Kortepeter, Mark G., additional, Kraft, Colleen S., additional, Kratochvil, Chris J., additional, Martins, Karen, additional, McLellan, Susan, additional, Mehta, Aneesh K., additional, Risi, George, additional, Sauer, Lauren, additional, Shenoy, Erica S., additional, and Uyeki, Tim, additional

Published
2021
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48. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies

Author

Arduino, Roberto C., Nannini, Esteban C., Rodriguez-Barradas, Maria, Schrader, Shannon, Losso, Marcelo, Ruxrungtham, Kiat, Allende, Maria C., Emery, Sean, Fosdick, Lisa, Neaton, James, Tavel, Jorge A., Davey, Richard T., and Lane, H. Clifford

Subjects
HIV (Viruses) -- Research, HIV (Viruses) -- Care and treatment, Interleukin-2 -- Usage, Health, Health care industry
Published
2004

50. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of >=300/mm(super 3): CPCRA 059

Author

Abrams, Donald I., Bebchuk, Judith D., Denning, Eileen T., Davey, Richard T., Fox, Lawrence, Lane, H. Clifford, Sampson, James, Verheggen, Rita, Zeh, Douglas, and Markowitz, Norman P.

Subjects
Interleukin-2 -- Health aspects, HIV infection -- Care and treatment, Health
Abstract

Interleukin-2 can increase CD4+ T cell counts in HIV patients even though it has no effect on HIV. This was the conclusion of a study of 511 HIV patients, all of whom were also taking AIDS drugs. Studies have shown that even if a patient responds to an AIDS drug, their immune system may not completely recover.

Published
2002

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