Publications by authors named "Betty Kalama"
Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are "controlled" by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases.
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- Snakebites impact over 5 million people annually, leading to over 100,000 deaths, with antivenom being the primary but problematic treatment due to its high cost and adverse effects.
- Unithiol, a chelating agent used for heavy metal poisoning, has shown promise in preventing tissue damage from certain viper species in small animal studies, prompting a clinical trial for snakebite treatment repurposing.
- The phase I trial will evaluate the safety of escalating doses of unithiol in 64 healthy volunteers, focusing on dose response, adverse effects, and pharmacokinetics, with the potential to offer a safer, orally-administered alternative to traditional antivenom.
Background: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.
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