publications from Studies supported by FHI Clinical

Title
Journal
Date
Indication
Ebola-negative neonates born to Ebola-infected mothers after monoclonal antibody therapy: a case series
Lancet Child and Adolescent Health
2020/12
Ebola
Challenges for drug repurposing in the COVID-19 pandemic era
Frontiers in Pharmacology
2020/11
COVID-19
Remdesivir for the treatment of Covid-19 — final report
New England Journal of Medicine
2020/10
COVID-19
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
The 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
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
The American Journal of Tropical Medicine and Hygiene
2020/07
Malaria
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
The China tuberculosis clinical trials consortium network: a model for international TB clinical trials capacity building
Infectious Diseases of Poverty
2020/05
Tuberculosis
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
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
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
A randomized, controlled trial of Ebola virus disease therapeutics
New England Journal of Medicine
2019/12
Ebola
Portable infrared imaging for longitudinal limb volume monitoring in patients with lymphatic filariasis
PLoS Neglected Tropical Diseases
2019/10
Lymphatic filariasis
Scalable, semi-automated fluorescence reduction neutralization assay for qualitative assessment of Ebola virus-neutralizing antibodies in human clinical samples
PLoS One
2019/08
Ebola
PREVAIL I cluster vaccination study with rVSVΔG-ZEBOV-GP as part of a public health response in Liberia
The 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
A longitudinal study of Ebola sequelae in Liberia
New England Journal of Medicine
2019/03
Ebola
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
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
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
Timing of rotavirus vaccine doses and severe rotavirus gastroenteritis among vaccinated infants in low- and middle-income countries
Epidemiology
2018/11
Rotavirus gastroenteritis
A randomized trial of a new triple drug treatment for lymphatic filariasis
New England Journal of Medicine
2018/11
Lymphatic filariasis
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
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
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
Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries
Epidemiology and Infection
2018/04
Rotavirus gastroenteritis
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
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
The American Journal of Tropical Medicine and Hygiene
2018/01
Malaria
Use of a novel portable three-dimensional imaging system to measure limb volume and circumference in patients with filarial lymphedema
The American Journal of Tropical Medicine and Hygiene
2017/12
Lymphatic filariasis
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
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
The American Journal of Tropical Medicine and Hygiene
2017/07
Ebola
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
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
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
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
Assessing clinical research capacity in Vietnam: A framework for strengthening capability for clinical trials in developing countries
Public Health Reports
2016/05
Sepsis
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
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
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
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
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
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
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