(FirstResponder.gov)
8 May 2917. A clinical trial is recruiting participants to better understand the way vaccines work in the human body. Unlike conventional clinical studies testing a particular treatment, this trial, sponsored by the Human Vaccines Project, aims to explore in more detail the body’s interactions with a class of drugs, in this case vaccines.
The Human Vaccines Project is a coalition of pharmaceutical companies, research institutes, and academic medical centers examining the science behind the immune system, to help speed development of preventive and therapeutic vaccines. The group aims to overcome obstacles that prevent the engineering of the human immune system, to deliver lifelong protection against infectious diseases and non-communicable diseases like cancer.
This new trial is a demonstration of a commercially-available vaccine for hepatitis B, marketed as Energix-B by drug maker GlaxoSmithKline. The vaccine’s safety and effectiveness against hepatitis B, a viral infection in the liver, is already known. In this study, a team from the Vaccine Evaluation Center at University of British Columbia is more interested in finding out why some people can be protected by one dose of the vaccine, while other individuals need multiple doses.
The goal of the initiative, says Wayne Koff, CEO of the Human Vaccines Project in an organization statement is to determine, “the core principles of how the human immune system recognizes pathogens and fights diseases [to] enable a more precise approach for developing vaccines and immunotherapies for a wide range of diseases such as AIDS, tuberculosis, diabetes, multiple sclerosis and cancer.”
Researchers led by pediatrics and immunology professors Manish Sadarangani and Tobias Kollmann are recruiting 10 healthy individuals age 40 to 80, with no history of hepatitis B to receive injections of the vaccine. The clinical trial will look primarily at production of antibodies from the vaccine, but also measure a number of other factors involving chemical activity in the body.
Among the additional factors assessed are effects of the vaccine on the body’s genetic processes. The study plans to takes measures before and at several points after vaccinations in responses by T- and B-cells in the immune system, as well as DNA sequencing of those immune system cells. The researchers will also evaluate RNA sequencing of whole blood and immune system cells, analyze proteins in whole blood and white blood cells that are part of the immune system, changes in epigenetics, or alterations in the genome from outside the genetic code, metabolic analysis of blood plasma, and immune responses in local lymph nodes.
In addition, the team will assess natural microbe communities in the gut, nose, mouth, and skin before and after vaccination at various points up to 6 months following the injections.
“The licensed hepatitis B vaccine, which only works in about 30 percent of people on the first shot,” adds Kollmann, “is an ideal model vaccine to study general principles of human immunological protection because it is one of the few vaccines for which we know how it protects.”
The team plans to expand enrollment in the initial study to 20 participants, with the study eventually growing to several hundred individuals in all age groups, to include people from low- and middle-income regions.
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