Practical aspects of phase 3 vaccine trials in developing countries

2005 ◽  
pp. 249-265
Author(s):  
Brian Greenwood
Keyword(s):  
Developing Countries ◽  
Phase 3 ◽  
Vaccine Trials

Polio Vaccination in Developing Countries

PEDIATRICS ◽  
1971 ◽  
Vol 48 (4) ◽  
pp. 667-668
Author(s):  
Roy E. Brown ◽  
Michael Katz
Keyword(s):  
Developing Countries ◽  
Virus Vaccine ◽  
Excretion Rate ◽  
Polio Virus ◽  
Vaccine Trials ◽  
Letter To The Editor ◽  
Polio Vaccination

We have recently come across the Letter to the Editor from Dr. Shanti Ghosh,1 commenting on the trivalent oral polio virus vaccine trials reported by Hardy, et al. in Pediatrics.2 Although 96 to 100% of infants demonstrated satisfactory levels of immunity in Hardy's group, using a microneutralization titer technique, Dr. Ghosh describes disappointing results in children in India and Nigeria as indicated by low seroconversion rates, as well as very low enterovirus excretion rate in pre- and postimmunization specimens (7.8%).

Past, present and future of HIV vaccine trials in developing countries

Vaccine ◽  
2002 ◽  
Vol 20 (15) ◽  
pp. 1897-1898 ◽  
Author(s):  
José Esparza ◽  
Saladin Osmanov ◽  
Claire Pattou-Markovic ◽  
Coumba Touré ◽  
Marie-Louise Chang ◽  
...  
Keyword(s):  
Developing Countries ◽  
Hiv Vaccine ◽  
Hiv Vaccine Trials ◽  
Vaccine Trials

scholarly journals Covid-19 vaccine trials and ethics: Protection delayed is protection denied

2020 ◽  
pp. 01-03
Author(s):  
T Jacob John ◽  
Dhanya Dharmapalan
Keyword(s):  
Large Scale ◽  
Protective Efficacy ◽  
Informed Choice ◽  
Effective Vaccine ◽  
Compassionate Use ◽  
Vaccine Research ◽  
Phase 3 ◽  
Vaccine Candidates ◽  
Risk Of Death ◽  
Vaccine Trials

Abstract The Covid-19 pandemic is raging, taking a heavy toll of lives and livelihoods. The need for safe and effective vaccine(s) is urgent. Vaccine research has progressed rapidly and a few vaccine candidates have passed trial Phases 1 and 2, confirming reasonable safety and immunogenicity parameters. They are ready for large scale Phase 3 trials to quantify protective efficacy, if any, and to detect uncommon but serious adverse effects, if any. These developments present unprecedented opportunities and challenges, scientific and ethical. Globally hundreds die every day due to Covid-19, and emergency/compassionate use of vaccine candidates that are ready for Phase 3 trials are likely to save lives. We perceive an ethical imperative to allow such vaccination for those at high risk of death who voluntarily make such an informed choice – for them protection delayed will be tantamount to protection denied.

scholarly journals regCOVID: Tracking publications of registered COVID-19 studies

2021 ◽  
Author(s):  
Craig Mayer ◽  
Vojtech Huser
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
Late Phase ◽  
Phase 3 ◽  
Multiple Study ◽  
Vaccine Trials ◽  
Study Results ◽  
Phase Phase ◽  
Trial Phase

Abstract In response to the COVID-19 pandemic many clinical studies have been initiated leading to the need for efficient ways to track and analyze study results. We expanded our previous project that tracked registered COVID-19 clinical studies to also track result articles generated from these studies. We conducted searches of ClinicalTrials.gov and PubMed to identify articles linked to COVID-19 studies, and developed criteria based on the trial phase, intervention, location, and record recency to develop a prioritized list of result publications. We found 760 articles linked to 419 interventional trials (15.7% of all 2 669 COVID-19 interventional trials as of 15 August 2021), with 418 identified via abstract-link in PubMed and 342 via registry-link in ClinicalTrials.gov. Of the 419 trials publishing at least one article, 123 (29.4%) have multiple linked publications. We used an attention score to develop a prioritized list of all publications linked to COVID-19 trials and identified 58 publications that are result articles from late phase (Phase 3) trials with at least one US site and multiple study record updates. For COVID-19 vaccine trials, we found 69 linked result articles for 40 trials (13.9% of 290 total COVID-19 vaccine trials). Our method allows for the efficient identification of important COVID-19 articles that report results of registered clinical trials and are connected via a structured article-trial link.

Implementation of good clinical practice guidelines in vaccine trials in developing countries

Vaccine ◽  
2007 ◽  
Vol 25 (15) ◽  
pp. 2852-2857 ◽  
Author(s):  
Camilo J. Acosta ◽  
Claudia M. Galindo ◽  
R. Leon Ochiai ◽  
M. Carolina Danovaro-Holliday ◽  
Anne Laure-Page ◽  
...  
Keyword(s):  
Developing Countries ◽  
Clinical Practice ◽  
Clinical Practice Guidelines ◽  
Practice Guidelines ◽  
Good Clinical Practice ◽  
Vaccine Trials
Sign in / Sign up

Export Citation Format

Share Document