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Article ; Online: The Brief Case: Streptococcus intermedius Brain Abscesses in an Otherwise Healthy Young Man Diagnosed by 16S rRNA Gene Sequencing.

Hauser, Naomi / Werzen, Alissa / Rapaka, Rekha R

2022 Volume 60, Issue 1, Page(s) e0197020

MeSH term(s)	Brain Abscess/diagnosis ; Genes, rRNA ; Humans ; Male ; RNA, Ribosomal, 16S/genetics ; Streptococcal Infections/diagnosis ; Streptococcus intermedius/genetics
Chemical Substances	RNA, Ribosomal, 16S
Language	English
Publishing date	2022-01-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	390499-4
ISSN	1098-660X ; 0095-1137
ISSN (online)	1098-660X
ISSN	0095-1137
DOI	10.1128/JCM.01970-20
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Article ; Online: Are Some COVID-19 Vaccines Better Than Others? Interpreting and Comparing Estimates of Efficacy in Vaccine Trials.

Rapaka, Rekha R / Hammershaimb, Elizabeth A / Neuzil, Kathleen M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2021 Volume 74, Issue 2, Page(s) 352–358

Abstract: Coronavirus disease 2019 (COVID-19) vaccine trials provide valuable insight into the safety and efficacy of vaccines, with individually randomized, placebo-controlled trials being the gold standard in trial design. However, a myriad of variables must be ... ...

Abstract	Coronavirus disease 2019 (COVID-19) vaccine trials provide valuable insight into the safety and efficacy of vaccines, with individually randomized, placebo-controlled trials being the gold standard in trial design. However, a myriad of variables must be considered as clinical trial data are interpreted and used to guide policy decisions. These variables include factors such as the characteristics of the study population and circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains, the force of infection, the definition and ascertainment of endpoints, the timing of vaccine efficacy assessment, and the potential for performance bias. In this Viewpoints article, we discuss critical variables to consider when comparing efficacy measurements across current and future COVID-19 vaccine trials.
MeSH term(s)	COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Humans ; Randomized Controlled Trials as Topic ; Treatment Outcome
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2021-02-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciab213
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Article ; Online: An Immunocompromised Woman with a Brain Lesion.

Hauser, Naomi / Luethy, Paul M / Rapaka, Rekha R

The American journal of medicine

2020 Volume 133, Issue 9, Page(s) e516–e517

MeSH term(s)	Anti-Bacterial Agents/therapeutic use ; Brain Abscess/microbiology ; Female ; Humans ; Immunocompromised Host ; Immunosuppressive Agents/pharmacology ; Middle Aged ; Mycophenolic Acid/pharmacology ; Nocardia ; Nocardia Infections/diagnosis ; Nocardia Infections/microbiology ; Nocardia Infections/pathology ; Nocardia Infections/therapy ; Prednisone/pharmacology
Chemical Substances	Anti-Bacterial Agents ; Immunosuppressive Agents ; Mycophenolic Acid (HU9DX48N0T) ; Prednisone (VB0R961HZT)
Language	English
Publishing date	2020-03-19
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	80015-6
ISSN	1555-7162 ; 1873-2178 ; 0002-9343 ; 1548-2766
ISSN (online)	1555-7162 ; 1873-2178
ISSN	0002-9343 ; 1548-2766
DOI	10.1016/j.amjmed.2020.02.021
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Article: Using Adjuvants to Drive T Cell Responses for Next-Generation Infectious Disease Vaccines.

Rapaka, Rekha R / Cross, Alan S / McArthur, Monica A

Vaccines

2021 Volume 9, Issue 8

Abstract: Using adjuvants to drive features of T cell responses to vaccine antigens is an important technological challenge in the design of new and improved vaccines against infections. Properties such as T helper cell function, T cell memory, and CD8+ T cell ... ...

Abstract	Using adjuvants to drive features of T cell responses to vaccine antigens is an important technological challenge in the design of new and improved vaccines against infections. Properties such as T helper cell function, T cell memory, and CD8+ T cell cytotoxicity may play critical roles in optimal and long-lived immunity through vaccination. Directly manipulating specific immune activation or antigen delivery pathways with adjuvants may selectively augment desired T cell responses in vaccination and may improve the effectiveness and durability of vaccine responses in humans. In this review we outline recently studied adjuvants in their potential for antigen presenting cell and T cell programming during vaccination, with an emphasis on what has been observed in studies in humans as available.
Language	English
Publishing date	2021-07-24
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines9080820
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Article ; Online: Using Adjuvants to Drive T Cell Responses for Next-Generation Infectious Disease Vaccines

Rekha R. Rapaka / Alan S. Cross / Monica A. McArthur

Vaccines, Vol 9, Iss 820, p

2021 Volume 820

Abstract	Using adjuvants to drive features of T cell responses to vaccine antigens is an important technological challenge in the design of new and improved vaccines against infections. Properties such as T helper cell function, T cell memory, and CD8+ T cell cytotoxicity may play critical roles in optimal and long-lived immunity through vaccination. Directly manipulating specific immune activation or antigen delivery pathways with adjuvants may selectively augment desired T cell responses in vaccination and may improve the effectiveness and durability of vaccine responses in humans. In this review we outline recently studied adjuvants in their potential for antigen presenting cell and T cell programming during vaccination, with an emphasis on what has been observed in studies in humans as available.
Keywords	T cell ; adjuvant ; differentiation ; antigen presenting cell ; CD8+ T cell ; CD4+ T cell ; Medicine ; R
Language	English
Publishing date	2021-07-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: CD4

Rapaka, Rekha R / Dai, Guixiang / Zheng, Mingquan / Kolls, Jay K

Infection and immunity

2019 Volume 87, Issue 7

Abstract: ... ...

Abstract	Pneumocystis
MeSH term(s)	Animals ; CD4-Positive T-Lymphocytes/immunology ; Cell Wall/metabolism ; Chitin/analysis ; Chitosan/analysis ; Cross Reactions/immunology ; Immunoglobulin G/immunology ; Lung/metabolism ; Lymphocyte Depletion ; Mice, Inbred BALB C ; Pneumocystis/immunology ; Pneumonia, Pneumocystis/immunology ; T-Lymphocytes, Regulatory/immunology ; beta-Glucans/immunology
Chemical Substances	Immunoglobulin G ; beta-Glucans ; Chitin (1398-61-4) ; Chitosan (9012-76-4)
Language	English
Publishing date	2019-06-20
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	218698-6
ISSN	1098-5522 ; 0019-9567
ISSN (online)	1098-5522
ISSN	0019-9567
DOI	10.1128/IAI.00158-19
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Article ; Online: Immune reconstitution inflammatory syndrome associated with pulmonary pathogens.

Gopal, Radha / Rapaka, Rekha R / Kolls, Jay K

European respiratory review : an official journal of the European Respiratory Society

2017 Volume 26, Issue 143

Abstract: Immune reconstitution inflammatory syndrome (IRIS) is an exaggerated immune response to a variety of pathogens in response to antiretroviral therapy-mediated recovery of the immune system in HIV-infected patients. Although IRIS can occur in many organs, ... ...

Abstract	Immune reconstitution inflammatory syndrome (IRIS) is an exaggerated immune response to a variety of pathogens in response to antiretroviral therapy-mediated recovery of the immune system in HIV-infected patients. Although IRIS can occur in many organs, pulmonary IRIS, associated with opportunistic infections such as Mycobacterium tuberculosis and Pneumocystis jirovecii, is particularly associated with high morbidity and mortality. The pathology of IRIS is associated with a variety of innate and adaptive immune factors, including CD4
MeSH term(s)	Adaptive Immunity ; Animals ; Cytokines/immunology ; Cytokines/metabolism ; Disease Models, Animal ; Host-Pathogen Interactions/immunology ; Humans ; Immune Reconstitution Inflammatory Syndrome/diagnosis ; Immune Reconstitution Inflammatory Syndrome/genetics ; Immune Reconstitution Inflammatory Syndrome/immunology ; Immune Reconstitution Inflammatory Syndrome/metabolism ; Immunity, Innate ; Inflammation Mediators/immunology ; Inflammation Mediators/metabolism ; Lymphocyte Subsets/immunology ; Lymphocyte Subsets/metabolism ; Mice, Knockout ; Primates ; Prognosis ; Respiratory Tract Infections/diagnosis ; Respiratory Tract Infections/genetics ; Respiratory Tract Infections/immunology ; Respiratory Tract Infections/metabolism ; Signal Transduction ; Toll-Like Receptors/immunology ; Toll-Like Receptors/metabolism
Chemical Substances	Cytokines ; Inflammation Mediators ; Toll-Like Receptors
Language	English
Publishing date	2017-01-03
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1077620-5
ISSN	1600-0617 ; 0905-9180
ISSN (online)	1600-0617
ISSN	0905-9180
DOI	10.1183/16000617.0042-2016
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Zs.A 3265: Show issues

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Article ; Online: A Risk Profile Using Simple Hematologic Parameters to Assess Benefits From Baricitinib in Patients Hospitalized With COVID-19: A Post Hoc Analysis of the Adaptive COVID-19 Treatment Trial-2.

Annals of internal medicine

2024 Volume 177, Issue 3, Page(s) 343–352

Abstract: Background: The ACTT risk profile, which was developed from ACTT-1 (Adaptive COVID-19 Treatment Trial-1), demonstrated that hospitalized patients with COVID-19 in the high-risk quartile (characterized by low absolute lymphocyte count [ALC], high ... ...

Abstract	Background: The ACTT risk profile, which was developed from ACTT-1 (Adaptive COVID-19 Treatment Trial-1), demonstrated that hospitalized patients with COVID-19 in the high-risk quartile (characterized by low absolute lymphocyte count [ALC], high absolute neutrophil count [ANC], and low platelet count at baseline) benefited most from treatment with the antiviral remdesivir. It is unknown which patient characteristics are associated with benefit from treatment with the immunomodulator baricitinib. Objective: To apply the ACTT risk profile to the ACTT-2 cohort to investigate potential baricitinib-related treatment effects by risk quartile. Design: Post hoc analysis of ACTT-2, a randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04401579). Setting: Sixty-seven trial sites in 8 countries. Participants: Adults hospitalized with COVID-19 ( Intervention: Baricitinib+remdesivir versus placebo+remdesivir. Measurements: Mortality, progression to invasive mechanical ventilation (IMV) or death, and recovery, all within 28 days; ALC, ANC, and platelet count trajectories. Results: In the high-risk quartile, baricitinib+remdesivir was associated with reduced risk for death (hazard ratio [HR], 0.38 [95% CI, 0.16 to 0.86]; Limitation: Secondary analysis of data collected before circulation of current SARS-CoV-2 variants. Conclusion: The ACTT risk profile identifies a subgroup of hospitalized patients who benefit most from baricitinib treatment and captures a patient phenotype of treatment response to an immunomodulator and an antiviral. Changes in ALC and ANC trajectory suggest a mechanism whereby an immunomodulator limits severe COVID-19. Primary funding source: National Institute of Allergy and Infectious Diseases.
MeSH term(s)	Adult ; Humans ; Antiviral Agents/adverse effects ; Azetidines ; COVID-19 ; COVID-19 Drug Treatment ; Immunologic Factors ; Purines ; Pyrazoles ; SARS-CoV-2 ; Sulfonamides ; Treatment Outcome ; Double-Blind Method
Chemical Substances	Antiviral Agents ; Azetidines ; baricitinib (ISP4442I3Y) ; Immunologic Factors ; Purines ; Pyrazoles ; Sulfonamides
Language	English
Publishing date	2024-02-27
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M23-2593
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Article ; Online: Efficacy and immunogenicity following dengue virus-1 human challenge after a tetravalent prime-boost dengue vaccine regimen: an open-label, phase 1 trial.

Lyke, Kirsten E / Chua, Joel V / Koren, Michael / Friberg, Heather / Gromowski, Gregory D / Rapaka, Rekha R / Waickman, Adam T / Joshi, Sudhaunshu / Strauss, Kathleen / McCracken, Michael K / Gutierrez-Barbosa, Hernando / Shrestha, Biraj / Culbertson, Christopher / Bernal, Paula / De La Barrera, Rafael A / Currier, Jeffrey R / Jarman, Richard G / Edelman, Robert

The Lancet. Infectious diseases

2024

Abstract: Background: Dengue human infection models (DHIMs) are important tools to down-select dengue vaccine candidates and establish tetravalent efficacy before advanced clinical field trials. We aimed to provide data for the safety and immunogenicity of DHIM ... ...

Abstract	Background: Dengue human infection models (DHIMs) are important tools to down-select dengue vaccine candidates and establish tetravalent efficacy before advanced clinical field trials. We aimed to provide data for the safety and immunogenicity of DHIM and evaluate dengue vaccine efficacy. Methods: We performed an open-label, phase 1 trial at the University of Maryland (Baltimore, MD, USA). Eligible participants were healthy individuals aged 18-50 years who either previously received a tetravalent dengue purified inactivated vaccine prime followed by a live-attenuated vaccine boost (ie, the vaccinee group), or were unvaccinated flavivirus-naive participants (ie, the control group). Participants in the vaccinee group with detectable pre-challenge dengue virus-1 neutralising antibody titres and flavivirus-naive participants in the control group were inoculated with dengue virus-1 strain 45AZ5 in the deltoid region, 27-65 months following booster dosing. These participants were followed-up from days 4-16 following dengue virus-1 live virus human challenge, with daily real-time quantitative PCR specific to dengue virus-1 RNA detection, and dengue virus-1 solicited local and systemic adverse events were recorded. The primary outcomes were safety (ie, solicited local and systemic adverse events) and vaccine efficacy (ie, dengue virus-1 RNAaemia) following dengue challenge. This study is registered with ClinicalTrials.gov, number NCT04786457. Findings: In January 2021, ten eligible participants were enrolled; of whom, six (60%) were in the vaccinee group and four (40%) were in the control group. Daily quantitative PCR detected dengue virus-1 RNA in nine (90%) of ten participants (five [83%] of six in the vaccinee group and all four [100%] in the control group). The mean onset of RNAaemia occurred on day 5 (SD 1·0) in the vaccinee group versus day 8 (1·5) in the control group (95% CI 1·1-4·9; p=0·007), with a trend towards reduced RNAaemia duration in the vaccinee group compared with the control group (8·2 days vs 10·5 days; 95% CI -0·08 to 4·68; p=0·056). Mild-to-moderate symptoms (nine [90%] of ten), leukopenia (eight [89%] of nine), and elevated aminotransferases (seven [78%] of nine) were commonly observed. Severe adverse events were detected only in the vaccinee group (fever ≥38·9°C in three [50%] of six, headache in one [17%], and transient grade 4 aspartate aminotransferase elevation in one [17%]). No deaths were reported. Interpretation: Participants who had tetravalent dengue purified inactivated vaccine prime and live-attenuated vaccine boost were unprotected against dengue virus-1 infection and further showed increased clinical, immunological, and transcriptomic evidence for inflammation potentially mediated by pre-existing infection-enhancing antibodies. This study highlights the impact of small cohort, human challenge models studying dengue pathogenesis and downstream vaccine development. Funding: Military Infectious Disease Research Program and Medical Technology Enterprise Consortium and Advanced Technology International.
Language	English
Publishing date	2024-04-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(24)00100-2
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Article ; Online: 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.

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 / Benson, Constance A

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 74, Issue 7, Page(s) 1260–1264

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 ... ...

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.
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Antiviral Agents/therapeutic use ; Clinical Trials as Topic ; Humans ; Respiration, Artificial ; SARS-CoV-2 ; COVID-19 Drug Treatment
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2022-04-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciab695
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