publications from Studies supported by FHI Clinical

Title
Journal
Date
Indication
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
COVID-19
Effect of a single dose of 8 mg moxidectin or 150 μg/kg ivermectin on O. volvulus skin microfilariae in a randomized trial: differences between areas in the Democratic Republic of the Congo, Liberia and Ghana and impact of intensity of infection
Onchocerciasis
2022/04
Onchocerciasis
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
Malaria
Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi
Scientific Reports
2022/03
Pneumonia
Final analysis of efficacy and safety of single-dose Ad26.COV2.S
New England Journal of Medicine
2022/03
COVID-19
Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1
Scientific Reports
2022/03
Cardiovascular disease
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
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
Malaria
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
HIV
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
Pneumonia
Efficacy, safety and tolerability of pyronaridine-artesunate in asymptomatic malaria-infected individuals: a randomized controlled trial
Clinical Infectious Diseases
2022/01
Malaria
Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study
The Lancet Infectious Diseases
2022/01
Rotavirus gastroenteritis
Efficacy and safety following bosutinib dose reduction in patients with Philadelphia chromosome‒positive leukemias
Leukemia Research
2021/12
Leukemia
A plain language summary of how well the single-dose Janssen vaccine works and how safe it is
Future Virology
2021/11
COVID-19
Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials
PLOS Pathogens
2021/11
HIV
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
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
Pneumococcal pneumonia
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
COVID-19
Effect of scheduled antimicrobial and nicotinamide treatment on linear growth in children in rural Tanzania: A factorial randomized, double-blind, placebo-controlled trial
PLoS Medicine
2021/09
Nutrition
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
A randomized double-blind controlled trial of convalescent plasma in adults with severe COVID-19
The Journal of Clinical Evaluation
2021/07
COVID-19
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
Genetic associations with weight gain among South Africans who initiated dolutegravir-containing and tenofovir-containing regimens
Journal of Acquired Immune Deficiency Syndrome
2021/07
HIV
Optimising pyrazinamide for the treatment of tuberculosis
European Respiratory Review
2021/07
Tuberculosis
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
COVID-19
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
Pneumococcal pneumonia
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
Malaria
Evidence for in vitro and in vivo activity of the antimalarial pyronaridine against Schistosoma
PLoS Neglected Tropical Diseases
2021/06
Schistosomiasis
Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19
New England Journal of Medicine
2021/06
COVID-19
Antihypertensives and statin therapy for primary stroke prevention: A secondary analysis of the HOPE-3 trial
Stroke
2021/05
Cardiovascular disease
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
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
Pneumococcal pneumonia
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
Tuberculosis
Vadadustat in patients with anemia and non-dialysis-dependent CKD
New England Journal of Medicine
2021/04
Chronic kidney disease
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
2021/03
Ebola
Malawian children with fast-breathing pneumonia with and without comorbidities
Pneumonia
2021/02
Pneumonia
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
Malaria
Impact of dose reduction on efficacy: implications of exposure-response analysis of palbociclib
Targeted Oncology
2021/01
Breast cancer
REGN-EB3: first approval
Drugs
2021/01
Ebola
Prevalence of Streptococcus pneumoniae in conjunctival flora and association with nasopharyngeal carriage among children in a Vietnamese community
Scientific Reports
2021/01
Pneumonia
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
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
Tuberculosis
Ebola-negative neonates born to Ebola-infected mothers after monoclonal antibody therapy: a case series
Lancet Child and Adolescent Health
2020/12
Ebola
Reduced efficacy of HIV-1 integrase inhibitors in patients with drug resistance mutations in reverse transcriptase
Nature Communications
2020/12
HIV
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
HIV
Challenges for drug repurposing in the COVID-19 pandemic era
Frontiers in Pharmacology
2020/11
COVID-19
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
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
Tuberculosis
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
HIV
Remdesivir for the treatment of Covid-19 — final report
New England Journal of Medicine
2020/10
COVID-19
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
HIV
Pharmacogenetic assessment of tafenoquine efficacy in patients with Plasmodium vivax malaria
Pharmacogenetics and Genomics
2020/09
Malaria
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
Malaria
Brief communication: immunogenicity of measles vaccine when co-administered with 10-valent pneumococcal conjugate vaccine
NPJ Vaccines
2020/08
Pneumonia
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
Tuberculosis
Amoxicillin for 3 or 5 days for chest-indrawing pneumonia in Malawian children
New England Journal of Medicine
2020/07
Pneumonia
Respiratory syncytial virus vaccination during pregnancy and effects in infants
New England Journal of Medicine
2020/07
Respiratory syncytial virus
Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial
The Lancet Infectious Diseases
2020/07
Rotavirus gastroenteritis
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
Malaria
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
COVID-19
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
Tuberculosis
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
Ebola
Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial
Bulletin of the World Health Organization
2020/05
Tuberculosis
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building
Infectious Diseases of Poverty
2020/05
Tuberculosis
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
Effect of a chikungunya virus–like particle vaccine on safety and tolerability outcomes
JAMA
2020/04
Chikungunya
Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings
Clinical Trials
2020/04
Pneumonia
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
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
Tuberculosis
Fourteen-day bactericidal activity, safety, and pharmacokinetics of linezolid in adults with drug-sensitive pulmonary tuberculosis
Antimicrobial Agents and Chemotherapy
2020/03
Tuberculosis
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
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
Ebola
Safety, tolerability, pharmacokinetics, and antimalarial activity of the novel plasmodium phosphatidylinositol 4-kinase inhibitor MMV390048 in healthy volunteers
Antimicrobial Agents and Chemotherapy
2020/03
Malaria
The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis
Parasites & Vectors
2020/03
Lymphatic filariasis
A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1)
Vaccine
2020/02
Avian influenza
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
Pneumonia
Safety of retigabine in adults with partial-onset seizures after long-term exposure: focus on unexpected ophthalmological and dermatological events
Epilepsy and Behavior
2020/01
Seizures
A randomized, controlled trial of Ebola virus disease therapeutics
New England Journal of Medicine
2019/12
Ebola
Cytomegalovirus infection is a risk factor for tuberculosis disease in infants
JCI Insight
2019/12
Tuberculosis
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
Cardiology
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
Portable infrared imaging for longitudinal limb volume monitoring in patients with lymphatic filariasis
PLoS Neglected Tropical Diseases
2019/10
Lymphatic filariasis
Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
BMJ Open Respiratory Research
2019/09
Pneumonia
Neutropenia management with palbociclib in Japanese patients with advanced breast cancer
Breast Cancer Research and Treatment
2019/09
Breast cancer
Dolutegravir plus two different prodrugs of tenofovir to treat HIV
New England Journal of Medicine
2019/08
HIV
Scalable, semi-automated fluorescence reduction neutralization assay for qualitative assessment of Ebola virus-neutralizing antibodies in human clinical samples
PLoS One
2019/08
Ebola
Immunological monitoring of newly diagnosed CML patients treated with bosutinib or imatinib first-line
OncoImmunology
2019/07
Leukemia
The cost implication of primary prevention in the HOPE 3 trial
European Heart Journal
2019/07
Cardiovascular disease
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
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
Patient-reported outcomes in the phase 3 BFORE trial of bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia
Journal of Cancer Research and Clinical Oncology
2019/06
Leukemia
PREVAIL I cluster vaccination study with rVSVΔG-ZEBOV-GP as part of a public health response in Liberia
Journal of Infectious Diseases
2019/05
Ebola
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
Pneumonia
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
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
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
A longitudinal study of Ebola sequelae in Liberia
New England Journal of Medicine
2019/03
Ebola
A trial of a shorter regimen for rifampin-resistant tuberculosis
New England Journal of Medicine
2019/03
Tuberculosis
Effects of blood pressure and lipid lowering on cognition: Results from the HOPE-3 study
Neurology
2019/03
Cardiovascular disease
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
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
Ebola
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
Tuberculosis
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
Malaria
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
Pneumonia
Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria
New England Journal of Medicine
2019/01
Malaria
Tafenoquine versus primaquine to prevent relapse of Plasmodium vivax malaria
New England Journal of Medicine
2019/01
Malaria
A randomized trial of a new triple drug treatment for lymphatic filariasis
New England Journal of Medicine
2018/11
Lymphatic filariasis
First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1
PLoS One
2018/11
HIV
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
HIV
Timing of rotavirus vaccine doses and severe rotavirus gastroenteritis among vaccinated infants in low- and middle-income countries
Epidemiology
2018/11
Rotavirus gastroenteritis
Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial
The Lancet
2018/11
Onchocerciasis
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
Ebola
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
Pneumonia
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
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
Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT): a protocol for a randomised factorial, double-blind, placebo-controlled trial of azithromycin, nitazoxanide and nicotinamide
BMJ Open
2018/07
Malnutrition
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
HIV
Prevention of M. tuberculosis infection with H4:IC31 vaccine or BCG revaccination
New England Journal of Medicine
2018/07
Tuberculosis
Residual inflammatory risk on treatment with PCSK9 inhibition and statin therapy
Circulation
2018/07
Cardiovascular disease
Utilizing nurses to staff an Ebola vaccine clinical trial in Sierra Leone during the Ebola outbreak
Journal of Infectious Diseases
2018/06
Ebola
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
Ebola
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
Ebola
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
Ebola
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
Ebola
Monitoring serious adverse events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola
Journal of Infectious Diseases
2018/06
Ebola
Lessons learned in clinical trial communication during an Ebola outbreak: The implementation of STRIVE
Journal of Infectious Diseases
2018/06
Ebola
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
Ebola
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
Ebola
Evaluation of different infant vaccination schedules incorporating pneumococcal vaccination (The Vietnam Pneumococcal Project): protocol of a randomised controlled trial
BMJ Open
2018/06
Pneumonia
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
Ebola
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
Ebola
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
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
Malaria
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
Tuberculosis
Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries
Epidemiology and Infection
2018/04
Rotavirus gastroenteritis
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
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
Tuberculosis
Utility of SOFA score, management and outcomes of sepsis in Southeast Asia: a multinational multicenter prospective observational study
Journal of Intensive Care
2018/02
Sepsis
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
Malaria
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
Use of a novel portable three-dimensional imaging system to measure limb volume and circumference in patients with filarial lymphedema
American Journal of Tropical Medicine and Hygiene
2017/12
Lymphatic filariasis
Using biomarkers to predict TB treatment duration (Predict TB): a prospective, randomized, noninferiority, treatment shortening clinical trial
Gates Open Research
2017/11
Tuberculosis
Phase 2 placebo-controlled trial of two vaccines to prevent Ebola in Liberia
New England Journal of Medicine
2017/10
Ebola
Cerebrospinal fluid examination in survivors of Ebola virus disease
JAMA Neurology
2017/09
Ebola
Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials
Journal for the Immunotherapy of Cancer
2017/09
Melanoma
Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic
Vaccine
2017/08
Ebola
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
Ebola
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
Malaria
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
Tuberculosis
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
Tuberculosis
Cardiovascular efficacy and safety of bococizumab in high-risk patients
New England Journal of Medicine
2017/04
Cardiovascular disease
Establishment of a research pharmacy to support Ebola clinical research in Liberia
Science and Practice Advances in Pharmacy Practice
2017/04
Ebola
Causes and outcomes of sepsis in Southeast Asia: A multinational multicentre cross-sectional study
Lancet Global Health
2017/02
Sepsis
Assessment and optimization of the GeneXpert diagnostic platform for detection of Ebola virus RNA in seminal fluid
Journal of Infectious Diseases
2017/02
Ebola
Estimation of the in vivo MIC of cipargamin in uncomplicated Plasmodium falciparum malaria
Antimicrobial Agents and Chemotherapy
2017/01
Malaria
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
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
Tuberculosis
Heterogeneity of rotavirus vaccine efficacy among infants in developing countries
Pediatric Infectious Disease Journal
2017/01
Rotavirus gastroenteritis
High-dose rifampicin, moxifloxacin, and SQ109 for treating tuberculosis: a multi-arm, multi-stage randomised controlled trial
The Lancet: Infectious Diseases
2017/01
Tuberculosis
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
Ebola
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
A randomized, controlled trial of ZMapp for Ebola virus infection
New England Journal of Medicine
2016/10
Ebola
Antimalarial activity of KAF156 in falciparum and vivax malaria
New England Journal of Medicine
2016/09
Malaria
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
Ebola surveillance — Guinea, Liberia, and Sierra Leone
Morbidity and Mortality Weekly Report (MMWR)
2016/07
Ebola
Ebola virus persistence in semen of male survivors
Clinical Infectious Diseases
2016/06
Ebola
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
HIV
Assessing clinical research capacity in Vietnam: A framework for strengthening capability for clinical trials in developing countries
Public Health Reports
2016/05
Sepsis
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
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
HIV
Fostering collaboration on post-Ebola clinical research in Liberia
The Lancet Global Health
2016/04
Ebola
Factors associated with HIV viral load suppression on antiretroviral therapy in Vietnam
Journal of Virus Eradication
2016/04
HIV
Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: a randomized trial
Annals of Internal Medicine
2016/03
HIV
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
Short-course treatment for multidrug-resistant tuberculosis: the STREAM trials
European Respiratory Review
2016/03
Tuberculosis
Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges
Clinical Trials
2016/02
Ebola
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
Malaria
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
HIV
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
Malaria
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
Population pharmacokinetics of pyronaridine in pediatric malaria patients
Antimicrobial Agents and Chemotherapy
2015/12
Malaria
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
Tuberculosis
Icatibant for multiple hereditary angioedema attacks across the controlled and open-label extension phases of FAST-3
International Archives of Allergy and Immunology
2015/11
Angioedema
Talimogene laherparepvec improves durable response rate in patients with advanced melanoma
Journal Of Clinical Oncology
2015/09
Melanoma
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
Pneumonia
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
Tuberculosis
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
HIV
Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials
Vaccine
2015/05
HIV
Recombinant human-C1 inhibitor is effective and safe for repeat hereditary angioedema attacks
The Journal of Allergy and Clinical Immunology
2015/05
Angioedema
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
Tuberculosis
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
Tuberculosis
Effect of sodium zirconium cyclosilicate on potassium lowering for 28 days among outpatients with hyperkalemia: the HARMONIZE randomized clinical trial
JAMA Network
2014/12
Cardiology
Serum indoleamine 2,3-dioxygenase activity is associated with reduced immunogenicity following vaccination with MVA85A
BMC Infectious Diseases
2014/12
Tuberculosis
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
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
Tuberculosis
Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia
Allergy and Asthma Proceedings
2014/07
Angioedema
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
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
Tuberculosis
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
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
Malaria
Bosutinib safety and management of toxicity in leukemia patients with resistance or intolerance to imatinib and other tyrosine kinase inhibitors
Blood
2014/02
Leukemia
Helicase-primase inhibitor pritelivir for HSV-2 infection
New England Journal of Medicine
2014/01
Genital herpes
A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients
Journal of Infectious Diseases
2013/05
Dengue
Oseltamivir and inhaled zanamivir as influenza prophylaxis in Thai health workers: a randomized, double-blind, placebo-controlled safety trial over 16 weeks
Journal of Antimicrobial Chemotherapy
2013/03
Influenza
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
Tuberculosis
Health-related quality of life in chronic myeloid leukemia
Leukemia Research
2013/01
Chronic myeloid leukemia
Clinical efficacy of icatibant in the treatment of acute hereditary angioedema during the FAST-3 trial
Expert Review of Clinical Immunology
2012/11
Angioedema
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
Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials
Epilepsy Research
2012/08
Seizures
Clinical validation of a point-of-care multiplexed in vitro immunoassay using monoclonal antibodies (the MSD Influenza Test) in four hospitals in Vietnam
Journal of Clinical Microbiology
2012/05
Influenza
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
Malnutrition levels among vaccinated and unvaccinated children between 2 and 3 years of age following enrollment in a randomized clinical trial with the pentavalent rotavirus vaccine (PRV) in Bangladesh
Vaccine
2012/04
Rotavirus gastroenteritis
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
2012/01
Tuberculosis
Randomized placebo-controlled trial of the bradykinin B₂ receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial
Annals of Asthma, Allergy and Immunology
2011/12
Angioedema
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
Oncology
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
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
HIV
Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants
Journal of Infectious Diseases
2011/06
Tuberculosis
Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants
Pediatric Infectious Disease Journal
2011/04
Polyvalent vaccine
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial
The Lancet
2010/08
Rotavirus gastroenteritis
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial
The Lancet
2010/08
Rotavirus gastroenteritis
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
Malaria
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
Tuberculosis
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
Tuberculosis
No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes
Diabetes Care
2009/08
Type 1 diabetes
Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa
Journal of Infectious Diseases
2008/08
Tuberculosis