publications from Studies supported by FHI Clinical

Table of Contents

Cardiology

Title
Journal
Date
Indication
Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1
Scientific Reports
2022/03
Cardiovascular disease
Lowering cholesterol, blood pressure, or both to prevent cardiovascular events: results of 8.7 years of follow-up of Heart Outcomes Evaluation Prevention (HOPE)-3 study participants
European Heart Journal
2021/08
Cardiovascular disease
Antihypertensives and statin therapy for primary stroke prevention: A secondary analysis of the HOPE-3 trial
Stroke
2021/05
Cardiovascular disease
Efficacy and safety of sodium zirconium cyclosilicate in patients with baseline serum potassium level ≥ 5.5 mmol/L: pooled analysis from two phase 3 trials
BMC Nephrology
2019/12
Cardiovascular and kidney diseases
The cost implication of primary prevention in the HOPE 3 trial
European Heart Journal
2019/07
Cardiovascular disease
Statin use in primary prevention: A simple trial-based approach compared with guideline-recommended risk algorithms for selection of eligible patients
Canadian Journal of Cardiology
2019/05
Cardiovascular disease
Effects of blood pressure and lipid lowering on cognition: Results from the HOPE-3 study
Neurology
2019/03
Cardiovascular disease
Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab
Journal of Clinical Lipidology
2018/07
Cardiovascular disease
Residual inflammatory risk on treatment with PCSK9 inhibition and statin therapy
Circulation
2018/07
Cardiovascular disease
Cardiovascular efficacy and safety of bococizumab in high-risk patients
New England Journal of Medicine
2017/04
Cardiovascular disease
Blood-pressure lowering in intermediate-risk persons without cardiovascular disease
New England Journal of Medicine
2016/05
Cardiovascular disease
Blood-pressure and cholesterol lowering in persons without cardiovascular disease
New England Journal of Medicine
2016/05
Cardiovascular disease
Cholesterol lowering in intermediate-risk persons without cardiovascular disease
New England Journal of Medicine
2016/05
Cardiovascular disease
Novel approaches in primary cardiovascular disease prevention: The HOPE-3 trial rationale, design, and participants’ baseline characteristics
Canadian Journal of Cardiology
2016/03
Cardiovascular disease
Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial
JAMA Network
2014/12
Cardiovascular and kidney diseases

COVID-19

Title
Journal
Date
Upamostat, a serine protease inhibitor, for outpatient treatment of COVID-19: a placebo-controlled, randomized pilot study
Journal of Medical Microbiology and Immunology Research
2022/07
Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial
The Lancet: Respiratory Medicine
2022/05
Final analysis of efficacy and safety of single-dose Ad26.COV2.S
New England Journal of Medicine
2022/03
A plain language summary of how well the single-dose Janssen vaccine works and how safe it is
Future Virology
2021/11
Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-blind, randomised, placebo-controlled, phase 3 trial
The Lancet Respiratory Medicine
2021/10
A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19
The Journal of Clinical Evaluation
2021/07
Performance analysis of the National Early Warning Score and Modified Early Warning Score in the Adaptive COVID-19 Treatment Trial cohort
Critical Care Explorations
2021/07
Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19
New England Journal of Medicine
2021/06
Challenges for drug repurposing in the COVID-19 pandemic era
Frontiers in Pharmacology
2020/11
Remdesivir for the treatment of Covid-19 — final report
New England Journal of Medicine
2020/10
Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Trials
2020/06

Ebola

Title
Journal
Date
Immunogenicity of rVSVΔG-ZEBOV-GP Ebola vaccine (ERVEBO®) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials
Vaccine
2022/11
PREVAIL IV: A randomized, double-blind, two-phase, phase 2 trial of remdesivir versus placebo for reduction of Ebola virus RNA in the semen of male survivors
Clinical Infectious Diseases
2021/11
REGN-EB3: first approval
Drugs
2021/01
Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries
Trials
2021/01
Ebola-negative neonates born to Ebola-infected mothers after monoclonal antibody therapy: a case series
Lancet Child and Adolescent Health
2020/12
Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus – Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis
Vaccine
2020/06
Pregnancy outcomes among women receiving rVSVΔ-ZEBOV-GP Ebola vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola
Emerging Infectious Diseases
2020/03
A randomized, controlled trial of Ebola virus disease therapeutics
New England Journal of Medicine
2019/12
Scalable, semi-automated fluorescence reduction neutralization assay for qualitative assessment of Ebola virus-neutralizing antibodies in human clinical samples
PLoS One
2019/08
PREVAIL I cluster vaccination study with rVSVΔG-ZEBOV-GP as part of a public health response in Liberia
Journal of Infectious Diseases
2019/05
A longitudinal study of Ebola sequelae in Liberia
New England Journal of Medicine
2019/03
Ebola virus disease-related stigma among survivors declined in Liberia over an 18-month, post-outbreak period: An observational cohort study
PLoS Neglected Tropical Diseases
2019/02
A review of strategies used to retain participants in clinical research during an infectious disease outbreak: The PREVAIL I Ebola vaccine trial experience
Contemporary Clinical Trials Communications
2018/09
Utilizing nurses to staff an Ebola vaccine clinical trial in Sierra Leone during the Ebola outbreak
Journal of Infectious Diseases
2018/06
The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An evaluation of rVSV∆G-ZEBOV-GP vaccine tolerability and safety during the West Africa Ebola outbreak
Journal of Infectious Diseases
2018/06
Rapid establishment of a cold chain capacity of –60°C or colder for the STRIVE Ebola vaccine trial during the Ebola outbreak in Sierra Leone
Journal of Infectious Diseases
2018/06
Participant retention in a randomized clinical trial in an outbreak setting: Lessons from the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
Journal of Infectious Diseases
2018/06
Operationalizing international regulatory standards in a limited-resource setting during an epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) experience
Journal of Infectious Diseases
2018/06
Monitoring serious adverse events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola
Journal of Infectious Diseases
2018/06
Lessons learned in clinical trial communication during an Ebola outbreak: The implementation of STRIVE
Journal of Infectious Diseases
2018/06
Implementing a multisite clinical trial in the midst of an Ebola outbreak: Lessons learned from the Sierra Leone Trial to Introduce a Vaccine Against Ebola
Journal of Infectious Diseases
2018/06
Health conditions in an adult population in Sierra Leone: Data reported from the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
Journal of Infectious Diseases
2018/06
Clinical surveillance and evaluation of suspected Ebola cases in a vaccine trial during an Ebola epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola
Journal of Infectious Diseases
2018/06
Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay
Journal of Virological Methods
2018/05
Phase 2 placebo-controlled trial of two vaccines to prevent Ebola in Liberia
New England Journal of Medicine
2017/10
Cerebrospinal fluid examination in survivors of Ebola virus disease
JAMA Neurology
2017/09
Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic
Vaccine
2017/08
Conventional wisdom versus actual outcomes: challenges in the conduct of an Ebola vaccine trial in Liberia during the International Public Health Emergency
American Journal of Tropical Medicine and Hygiene
2017/07
Establishment of a research pharmacy to support Ebola clinical research in Liberia
Science and Practice Advances in Pharmacy Practice
2017/04
Assessment and optimization of the GeneXpert diagnostic platform for detection of Ebola virus RNA in seminal fluid
Journal of Infectious Diseases
2017/02
Beating the odds: successful establishment of a phase II/III clinical research trial in resource-poor Liberia during the largest-ever Ebola outbreak
Contemporary Clinical Trials Communications
2016/12
A randomized, controlled trial of ZMapp for Ebola virus infection
New England Journal of Medicine
2016/10
Ebola surveillance — Guinea, Liberia, and Sierra Leone
Morbidity and Mortality Weekly Report (MMWR)
2016/07
Ebola virus persistence in semen of male survivors
Clinical Infectious Diseases
2016/06
Fostering collaboration on post-Ebola clinical research in Liberia
The Lancet Global Health
2016/04
Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges
Clinical Trials
2016/02

Hepatitis

Title
Journal
Date
Indication
The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial
Trials
2022/04
Hepatitis B virus, hepatitis C virus, hepatitis E virus, malaria, HIV and human herpesvirus 8

Herpes

Title
Journal
Date
Indication
Tenofovir gel for the prevention of herpes simplex virus type 2 infection
New England Journal of Medicine
2015/08
Herpes simplex viral (HSV) infection
Helicase-primase inhibitor pritelivir for HSV-2 infection
New England Journal of Medicine
2014/01
Genital herpes

HIV

Title
Journal
Date
Point-of-care tenofovir urine testing for the prediction of treatment failure and drug resistance during initial treatment for human immunodeficiency virus type 1 (HIV-1) infection
Clinical Infectious Diseases
2022/09
CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women
BMJ Open
2022/01
Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials
PLoS Pathogens
2021/11
Genetic associations with weight gain among South Africans who initiated dolutegravir-containing and tenofovir-containing regimens
Journal of Acquired Immune Deficiency Syndrome
2021/07
Altered antibody responses in persons infected with HIV-1 while using preexposure prophylaxis
AIDS Research and Human Retroviruses
2021/03
Reduced efficacy of HIV-1 integrase inhibitors in patients with drug resistance mutations in reverse transcriptase
Nature Communications
2020/12
Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial
BMJ Open
2020/11
Dolutegravir with emtricitabine and tenofovir alafenamide or tenofovir disoproxil fumarate versus efavirenz, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection (ADVANCE): week 96 results from a randomised, phase 3, non-inferiority trial
The Lancet: HIV
2020/10
Effect of Enhanced Adherence Package on Early ART Uptake Among HIV-Positive Pregnant Women in Zambia: An Individual Randomized Controlled Trial
AIDS and Behavior
2020/10
Dolutegravir plus two different prodrugs of tenofovir to treat HIV
New England Journal of Medicine
2019/08
First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1
PLoS One
2018/11
Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial
The Lancet: Infectious Diseases
2018/11
Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19)
The Lancet
2018/07
Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir Study
The Lancet: HIV
2017/02
First-in-human evaluation of the safety and immunogenicity of an intranasally administered replication-competent Sendai virus-vectored HIV type 1 Gag vaccine: induction of potent T-cell or antibody responses in prime-boost regimens
Journal of Infectious Diseases
2017/01
HIV-Tat immunization induces cross-clade neutralizing antibodies and CD4(+) T cell increases in antiretroviral-treated South African volunteers: a randomized phase II clinical trial
Retrovirology
2016/06
Repeated cycles of recombinant human interleukin 7 in HIV-infected patients with low CD4 T-cell reconstitution on antiretroviral therapy: results of 2 phase II multicenter studies
Clinical Infectious Behaviors
2016/05
Factors associated with HIV viral load suppression on antiretroviral therapy in Vietnam
Journal of Virus Eradication
2016/04
Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: a randomized trial
Annals of Internal Medicine
2016/03
Factors associated with HIV RNA viral loads in ART-naïve patients: implications for treatment as prevention in concentrated epidemics
Journal of Virus Eradication
2016/01
Assessment of oral fluid HIV test performance in an HIV pre-exposure prophylaxis trial in Bangkok, Thailand
PLoS One
2015/12
A phase I double blind, placebo-controlled, randomized study of the safety and immunogenicity of an adjuvanted HIV-1 Gag-Pol-Nef fusion protein and adenovirus 35 Gag-RT-Int-Nef vaccine in healthy HIV-uninfected African adults
PLoS One
2015/05
Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials
Vaccine
2015/05
The impact of adherence to preexposure prophylaxis on the risk of HIV infection among people who inject drugs
AIDS
2015/04
Renal function of participants in the Bangkok Tenofovir Study—Thailand, 2005–2012
Clinical Infectious Diseases
2014/09
Neither microbial translocation nor TLR responsiveness are likely explanations for preexisting immune activation in women who subsequently acquired HIV in CAPRISA 004
Journal of Acquired Immune Deficiency Syndromes
2013/07
Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial
The Lancet
2013/06
Women with pregnancies had lower adherence to 1% tenofovir vaginal gel as HIV preexposure prophylaxis in CAPRISA 004, a phase IIB randomized-controlled trial
PLoS One
2013/03
Natural killer cell function in women at high risk for HIV acquisition: insights from a microbicide trial
AIDS
2012/09
Enrollment characteristics and risk behaviors of injection drug users participating in the Bangkok Tenofovir Study, Thailand
PLoS One
2011/09
A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204)
PLoS One
2011/08
Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial
Trials
2011/03

Malaria

Title
Journal
Date
Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in western Kenya compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program)
Trials
2022/04
Diagnostic performance and comparison of ultrasensitive and conventional rapid diagnostic test, thick blood smear and quantitative PCR for detection of low-density Plasmodium falciparum infections during a controlled human malaria infection study in Equatorial Guinea
Malaria Journal
2022/03
Tafenoquine exposure assessment, safety, and relapse prevention efficacy in children with Plasmodium vivax malaria: open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 trial
The Lancet Child and Adolescent Health
2022/02
Efficacy, safety and tolerability of pyronaridine-artesunate in asymptomatic malaria-infected individuals: a randomized controlled trial
Clinical Infectious Diseases
2022/01
Pyronaridine–artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study
PLoS Medicine
2021/06
Hepatic safety of repeated treatment with pyronaridine‐artesunate versus artemether–lumefantrine in patients with uncomplicated malaria: a secondary analysis of the WANECAM 1 data from Bobo-Dioulasso, Burkina Faso
Malaria Journal
2021/01
Pharmacogenetic assessment of tafenoquine efficacy in patients with Plasmodium vivax malaria
Pharmacogenetics and Genomics
2020/09
The Equatoguinean Malaria Vaccine Initiative: from the launching of a clinical research platform to malaria elimination planning in central West Africa
American Journal of Tropical Medicine and Hygiene
2020/09
Efficacy of a spatial repellent for control of malaria in Indonesia: a cluster-randomized controlled trial
American Journal of Tropical Medicine and Hygiene
2020/07
Safety, tolerability, pharmacokinetics, and antimalarial activity of the novel Plasmodium phosphatidylinositol 4-kinase inhibitor MMV390048 in healthy volunteers
Antimicrobial Agents and Chemotherapy
2020/03
Evaluation of the effects on the QT-interval of 4 artemisinin-based combination therapies with a correction-free and heart rate-free method
Scientific Reports
2019/01
Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria
New England Journal of Medicine
2019/01
Tafenoquine versus primaquine to prevent relapse of Plasmodium vivax malaria
New England Journal of Medicine
2019/01
Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial
Lancet
2018/04
Advancing global health through development and clinical trials partnerships: a randomized, placebo-controlled, double-blind assessment of safety, tolerability, and immunogenicity of PfSPZ vaccine for malaria in healthy Equatoguinean men
American Journal of Tropical Medicine and Hygiene
2018/01
Abrogation of red blood cell G6PD enzyme activity through Heat treatment: development of survey material for the UK NEQAS G6PD scheme
International Journal of Laboratory Hemotology
2017/06
Estimation of the in vivo MIC of cipargamin in uncomplicated Plasmodium falciparum malaria
Antimicrobial Agents and Chemotherapy
2017/01
Antimalarial activity of KAF156 in falciparum and vivax malaria
New England Journal of Medicine
2016/09
Estimation of the antirelapse efficacy of tafenoquine, using Plasmodium vivax genotyping
The Journal of Infectious Diseases
2016/03
Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial
Lancet Infectious Diseases
2016/02
Antimalarial activity of artefenomel (OZ439), a novel synthetic antimalarial endoperoxide, in patients with Plasmodium falciparum and Plasmodium vivax malaria: an open-label phase 2 trial
Lancet Infectious Diseases
2016/01
Population pharmacokinetics of pyronaridine in pediatric malaria patients
Antimicrobial Agents and Chemotherapy
2015/12
Exposure-response analyses for tafenoquine after administration to patients with Plasmodium vivax malaria
Antimicrobial Agents and Chemotherapy
2015/10
Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study
The Lancet
2014/03
Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial
Lancet
2010/04

Nephrology

Title
Journal
Date
Indication
Vadadustat in patients with anemia and non-dialysis-dependent CKD
New England Journal of Medicine
2021/04
Chronic kidney disease

Oncology

Title
Journal
Date
Indication
Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis
International Journal of Hematology
2022/03
Chronic myeloid leukemia
Efficacy and safety following bosutinib dose reduction in patients with Philadelphia chromosome‒positive leukemias
Leukemia Research
2021/12
Leukemia
Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2
The Breast
2021/10
Breast cancer
Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial
International Journal of Hematology
2021/07
Leukemia
Evaluation of the association of polymorphisms with palbociclib-induced neutropenia: pharmacogenetic analysis of PALOMA-2/-3
The Oncologist
2021/07
Breast cancer
Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: updated analysis with up to 5 years of follow-up
The Oncologist
2021/05
Breast cancer
Impact of dose reduction on efficacy: implications of exposure-response analysis of palbociclib
Targeted Oncology
2021/01
Breast cancer
Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials
Breast Cancer Research and Treatment
2020/11
Breast cancer
Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer
PLoS ONE
2020/04
Breast cancer
Impact of the COVID-19 epidemic on a Pan-Asian academic oncology clinical trial
JCO Global Oncology
2020/04
Oncology
Progression-free survival outcome is independent of objective response in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with palbociclib plus letrozole compared with letrozole: analysis from PALOMA-2
Clinical Breast Cancer
2020/04
Breast cancer
Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies
Breast Cancer Research
2020/03
Breast cancer
Palbociclib with letrozole in postmenopausal women with ER+/HER2- advanced breast cancer: hematologic safety analysis of the randomized PALOMA-2 trial
The Oncologist
2019/12
Breast cancer
Neutropenia management with palbociclib in Japanese patients with advanced breast cancer
Breast Cancer Research and Treatment
2019/09
Breast cancer
Immunological monitoring of newly diagnosed CML patients treated with bosutinib or imatinib first-line
OncoImmunology
2019/07
Leukemia
Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial
The Lancet: Gastroenterology and Hepatology
2019/06
Hepatocellular carcinoma
Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma
Journal for the Immunotherapy of Cancer
2019/06
Melanoma
Palbociclib plus letrozole as first-line therapy in postmenopausal Asian women with metastatic breast cancer: results from the phase III, randomized PALOMA-2 study
Journal of Global Oncology
2019/05
Breast cancer
Long-term pooled safety analysis of palbociclib in combination with endocrine therapy for HR+/HER2- advanced breast cancer
Journal of the National Cancer Institute
2019/04
Breast cancer
Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up
Breast Cancer Research and Treatment
2019/04
Breast cancer
Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients
International Journal of Global Oncology
2019/03
Breast cancer
Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies
European Journal of Cancer
2018/09
Breast cancer
Safety and efficacy of second-line bosutinib for chronic phase chronic myeloid leukemia over a five-year period: final results of a phase I/II study
Journal of Clinical Lipidology
2018/08
Chronic myeloid leukemia
Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial
Annals of Oncology
2018/04
Breast cancer
Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases
Annals of Oncology
2018/03
Breast cancer
Long-term patient-reported outcomes from an open-label safety and efficacy study of bosutinib in Philadelphia chromosome-positive chronic myeloid leukemia patients resistant or intolerant to prior therapy
Cancer
2018/02
Chronic myeloid leukemia
Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial
Journal of Clinical Oncology
2018/01
Leukemia
Comprehensive analysis of survival outcomes in non-clear cell renal cell carcinoma patients treated in clinical trials
Clinical Genitourinary Cancer
2017/12
Renal cell carcinoma
Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials
Journal for the Immunotherapy of Cancer
2017/09
Melanoma
Early tumour shrinkage: a tool for the detection of early clinical activity in metastatic renal cell carcinoma
European Urology
2016/12
Metastatic renal cell carcinoma
Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib
American Journal of Hematology
2016/12
Chronic myeloid leukemia
Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the phase III OPTiM trial
OncoTargets and Therapy
2016/11
Melanoma
Palbociclib and letrozole in advanced breast cancer
New England Journal of Medicine
2016/11
Breast cancer
Health-related quality of life during bosutinib (SKI-606) therapy in patients with advanced chronic myeloid leukemia after imatinib failure
Current Medical Research and Opinion
2016/08
Chronic myeloid leukemia
Factors influencing long-term efficacy and tolerability of bosutinib in chronic phase chronic myeloid leukaemia resistant or intolerant to imatinib
British Journal of Hematology
2016/01
Chronic myeloid leukemia
Talimogene laherparepvec improves durable response rate in patients with advanced melanoma
Journal Of Clinical Oncology
2015/09
Melanoma
Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia
American Journal of Hematology
2014/10
Chronic myeloid leukemia
Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: Minimum 24-month follow-up
American Journal of Hematology
2014/07
Chronic myeloid leukemia
Population pharmacokinetic and pharmacodynamic analysis of bosutinib
Drug Metabolism and Pharmacokinetics
2014/05
Philadelphia chromosome–positive leukemia
Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial
Journal of Clinical Oncology
2014/03
Metastatic renal cell carcinoma
Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors
Blood
2014/02
Leukemia
Health-related quality of life in chronic myeloid leukemia
Leukemia Research
2013/01
Chronic myeloid leukemia
Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial
Journal of Clinical Oncology
2012/09
Chronic myeloid leukemia
Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure
Blood
2012/04
Chronic myeloid leukemia
Health-related quality of life of bosutinib (SKI-606) in imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia
Leukemia Research
2012/04
Chronic myeloid leukemia
The utility of aspirin in Dukes C and High Risk Dukes B colorectal cancer–the ASCOLT study: study protocol for a randomized controlled trial
Trials
2011/12
Colorectal cancer
Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib
Blood
2011/10
Chronic myeloid leukemia

Pneumonia

Title
Journal
Date
Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi
Scientific Reports
2022/03
Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis
BMC Pediatrics
2022/01
Simplified 0+1 and 1+1 pneumococcal vaccine schedules in Ho Chi Minh City, Vietnam: protocol for a randomised controlled trial
BMJ Open
2021/11
Immunogenicity of alternative ten-valent pneumococcal conjugate vaccine schedules in infants in Ho Chi Minh City, Vietnam: results from a single-blind, parallel-group, open-label, randomised, controlled trial
The Lancet Infectious Diseases
2021/10
Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial
The Lancet Infectious Diseases
2021/06
Effect of a 2+1 schedule of ten-valent versus 13-valent pneumococcal conjugate vaccine on pneumococcal carriage: Results from a randomised controlled trial in Vietnam
Vaccine
2021/04
Malawian children with fast-breathing pneumonia with and without comorbidities
Pneumonia
2021/02
Prevalence of Streptococcus pneumoniae in conjunctival flora and association with nasopharyngeal carriage among children in a Vietnamese community
Scientific Reports
2021/01
Brief communication: immunogenicity of measles vaccine when co-administered with 10-valent pneumococcal conjugate vaccine
NPJ Vaccines
2020/08
Amoxicillin for 3 or 5 days for chest-indrawing pneumonia in Malawian children
New England Journal of Medicine
2020/07
Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings
Clinical Trials
2020/04
Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia-Results of a phase 1/2 randomized, double-blinded, controlled trial
Vaccine
2020/01
Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
BMJ Open Respiratory Research
2019/09
Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial
The Lancet Infectious Diseases
2019/05
Placebo vs amoxicillin for nonsevere fast-breathing pneumonia in Malawian children aged 2 to 59 months: a double-blind, randomized clinical noninferiority trial
JAMA Pediatrics
2019/01
Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol
BMC Infectious Diseases
2018/09
Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial
BMJ Open
2018/06
TH17-mediated protection against pneumococcal carriage by a whole-cell vaccine is dependent on toll-like receptor 2 and surface lipoproteins
Clinical and Vaccine Immunology
2015/07

Respiratory syncytial virus (RSV)

Title
Journal
Date
Respiratory syncytial virus vaccination during pregnancy and effects in infants
New England Journal of Medicine
2020/07

Schistosomiasis

Tuberculosis

Title
Journal
Date
Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial
The Lancet
2022/11
Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial
The Lancet: Infectious Diseases
2022/10
Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis
Trials
2022/06
Adjunctive host-directed therapies for pulmonary tuberculosis: a prospective, open-label, phase 2, randomised controlled trial
The Lancet: Respiratory Medicine
2021/08
Optimising pyrazinamide for the treatment of tuberculosis
European Respiratory Review
2021/07
Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial
The Lancet: Respiratory Medicine
2021/04
Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial
BMJ Open
2020/12
DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: a randomized controlled, double-blind phase 2b trial
Vaccine
2020/10
The potential of CBC-derived ratios (monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte) to predict or diagnose incident TB infection in Tanzanian adolescents
BMC Infectious Diseases
2020/08
Once-weekly rifapentine and isoniazid for tuberculosis prevention in patients with HIV taking dolutegravir-based antiretroviral therapy: a phase 1/2 trial
The Lancet: HIV
2020/06
Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial
Bulletin of the World Health Organization
2020/05
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building
Infectious Diseases of Poverty
2020/05
A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa
eClinicalMedicine
2020/03
Fourteen-day bactericidal activity, safety, and pharmacokinetics of linezolid in adults with drug-sensitive pulmonary tuberculosis
Antimicrobial Agents and Chemotherapy
2020/03
Cytomegalovirus infection is a risk factor for tuberculosis disease in infants
JCI Insight
2019/12
A trial of a shorter regimen for rifampin-resistant tuberculosis
New England Journal of Medicine
2019/03
Dose optimization of H56:IC31 vaccine for tuberculosis-endemic populations. a double-blind, placebo-controlled, dose-selection trial
American Journal of Respiratory and Critical Care Medicine
2019/01
Prevention of M. tuberculosis infection with H4:IC31 vaccine or BCG revaccination
New England Journal of Medicine
2018/07
The impact of repeated NALC/NaOH- decontamination on the performance of Xpert MTB/RIF assay
Tuberculosis
2018/05
Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial
The Lancet Respiratory Medicine
2018/04
Safety and immunogenicity of newborn MVA85A vaccination and selective, delayed Bacille Calmette-Guerin for infants of human immunodeficiency virus-infected mothers: a phase 2 randomized, controlled trial
Clinical Infectious Diseases
2018/02
Using biomarkers to predict TB treatment duration (Predict TB): a prospective, randomized, noninferiority, treatment shortening clinical trial
Gates Open Research
2017/11
Safety and immunogenicity of the recombinant Mycobacterium bovis BCG vaccine VPM1002 in HIV-unexposed newborn infants in South Africa
Clinical and Vaccine Immunology
2017/06
Safety and immunogenicity of adenovirus 35 tuberculosis vaccine candidate in adults with active or previous tuberculosis. A randomized trial
American Journal of Respiratory and Critical Care Medicine
2017/05
H1:IC31 vaccination is safe and induces long-lived TNF-α+IL-2+CD4 T cell responses in M. tuberculosis infected and uninfected adolescents: A randomized trial
Vaccine
2017/01
High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial
The Lancet: Infectious Diseases
2017/01
Short-course treatment for multidrug-resistant tuberculosis: the STREAM trials
European Respiratory Review
2016/03
Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
BMC Medicine
2016/02
Evaluation of Xpert® MTB/RIF assay in induced sputum and gastric lavage samples from young children with suspected tuberculosis from the MVA85A TB vaccine trial
PLOS One
2015/11
The tuberculosis vaccine H4:IC31 is safe and induces a persistent polyfunctional CD4 T cell response in South African adults: A randomized controlled trial
Vaccine
2015/07
The safety and immunogenicity of an adenovirus type 35-vectored TB vaccine in HIV-infected, BCG-vaccinated adults with CD4(+) T cell counts >350 cells/mm(3)
Vaccine
2015/04
Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trial
The Lancet Respiratory Medicine
2015/03
Serum indoleamine 2,3-dioxygenase activity is associated with reduced immunogenicity following vaccination with MVA85A
BMC Infectious Diseases
2014/12
The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses
Vaccine
2014/10
Four-month moxifloxacin-based regimens for drug-sensitive tuberculosis
The New England Journal of Medicine
2014/10
Inflammatory and myeloid-associated gene expression before and one day after infant vaccination with MVA85A correlates with induction of a T cell response
BMC Infectious Diseases
2014/06
Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial
The Lancet
2013/02
A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis–infected adults
American Journal of Respiratory and Critical Care Medicine
2012/04
Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants
Journal of Infectious Diseases
2011/06
The novel tuberculosis vaccine, AERAS-402, induces robust and polyfunctional CD4+ and CD8+ T cells in adults
American Journal of Respiratory and Critical Care Medicine
2010/02
Modified vaccinia Ankara-expressing Ag85A, a novel tuberculosis vaccine, is safe in adolescents and children, and induces polyfunctional CD4+ T cells
European Journal of Immunology
2009/12
Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa
Journal of Infectious Diseases
2008/08