WHO and UNITAID
in collaboration with IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) network, PENTA (Paediatric European Network for Treatment of AIDS) foundation and experts from the Paediatric Antiretroviral Working Group
A systematic review of randomized controlled efficacy trials | REPORT -
DEPARTMENT OF CHILD AND ADOLESCENT HEALTH AND DEVELOPMENT
The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field
application rates of new molluscicide products for control of schistosomiasis.
This article is part two in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. This article focuses on the ingredients in a vaccine and the three clinical trial phases. Part three outlines the nex...t part of the vaccine journey: the steps from completing the clinical trial phases through to distribution
Available in English, French, Spanish, Arabic, Chinese and Russian
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COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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Interim guidance 2 march 2021
Current use of drugs to prevent COVID-19 is variable, reflecting large-scale uncertainty. Numerous randomized trials of many different drugs are underway to inform practice. This first version of the Drugs to prevent COVID-19: A WHO living guideline contains new inform...ation and a recommendation on hydroxychloroquine. It follows the publication of six trials synthesized in a living network meta-analysis (NMA).
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10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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The paper provides the rationale for these recommendations, which are based on analyses of data from the TRACT trial.
May 9, 2022.Since the onset of the COVID-19 pandemic, a large number of clinical trials have been planned and developed to assess the effectiveness and safety of various interventions that could prevent hospitalizations and progression to severe disease in people infected with SARS-CoV-2. Currently,... the WHO and the PAHO recommend the use of corticosteroids, tocilizumab, baricitinib, and casirivimab e imdevimab (the latter in seronegative COVID-19 patients) and propose the use of sotrovimab, casirivimab/imdevimab, and molnupiravir in patients with non-severe illness who are at high risk for complications
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Phillips and colleagues have shown that rifampicin combined with clarithromycin is non-inferior to RS8, and is safer. This much anticipated trial provides us with a high degree of confidence that an 8-week course of oral rifampicin and clarithromycin should now be the cornerstone of the treatment of... Buruli ulcer everywhere. However, this finding does not mean that
Buruli ulcer is cured at 8 weeks.
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The Global Programme to Eliminate Lymphatic Filariasis (LF) is using mass drug administration (MDA) of antifilarial medications to treat filarial infections, prevent disease and interrupt transmission. Almost 500 million people receive these medications each year. Clinical trials have recently shown... that a single dose of a triple-drug combination comprised of ivermectin, diethylcarbamazine and albendazole (IDA) is dramatically superior to widely used two-drug combinations for clearing larval filarial parasites from the blood of infected persons. A large mul-
ticenter community study showed that IDA was well-tolerated when it was provided as MDA. IDA was rapidly advanced from clinical trial to policy and implementation; it has the potential to accelerate LF elimination in many endemic countries.
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A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d...ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
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The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat...ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
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Sleeping sickness is controlled by case detection and treatment but this often only reaches less than 75% of the population. Vector control is capable of completely interrupting HAT transmission but is not used because of expense. We conducted a full scale field trial of a refined vector control tec...hnology. From preliminary trials we determined the number of insecticidal tiny targets required to control tsetse populations by more than 90%. We then carried out a full scale, 500 km2 field trial covering two HAT foci in Northern Uganda (overall target density 5.7/km2). In 12 months tsetse populations declined by more than 90%. A mathematical model suggested that a 72% reduction in tsetse population is required to stop transmission in those settings. The Ugandan census suggests population density in the HAT foci is approximately 500 per km2. The estimated cost for a single round of active case detection (excluding treatment), covering 80% of the population, is US$433,333 (WHO figures). One year of vector control organised within country, which can completely stop HAT transmission, would cost US$42,700. The case for adding this new method of vector control to case detection and treatment is strong. We outline how such a component could be organised.
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Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported ...serious adverse events (SAEs).
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WHO strongly recommends discontinuation of the nerve tissue vaccine, and replacement with modern concentrated and purified cell culture derived vaccines (CCDV) and embryonated eggbased rabies vaccines.
These vaccines must comply with WHO criteria for potency and innocuity following satisfactory ass...essment in humans during well-designed field trials
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The results of a large-scale systematic review and meta-analysis have published in PLOS Neglected Tropical Diseases. This research aimed to collate all reported serious adverse events (SAE) in visceral leishmaniasis (VL) clinical trials and quantify the incidence of mortality during the first 30 day...s of therapy. The analyses, which included clinical data from more than 35,000 patients, found that mortality following treatment was an extremely rare event and serious adverse events following treatments were poorly reported.
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The pharmacological treatment of heart failure has evolved over the last three decades since the demonstration of the effect of angiotensinconverting enzyme inhibitors on major cardiovascular events in patients with heart failure with reduced ejection fraction. Composite analysis of heart failure wi...th reduced ejection fraction trials and the recent identification of newer drug treatments show early benefits on the major cardiovascular outcomes, ushering in a change of the treatment strategy; from a ‘sequential’ initiation of the treatments to a ‘simultaneous’ initiation to harness the early benefits. The adoption and implementation of these changes at the bedside have been dismal in many healthcare settings. Papua New Guinea, like many other lower-to-middle-income countries, is facing many barriers that impact on the care of heart failure patients. It needs to adopt and implement these changes to provide evidence-based treatment for its people with heart failure with reduced ejection fraction.
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