Corona vacine
As mentioned earlier, Canada currently has at least seven vaccine candidates under development, with Canadian involvement in the development of some others. Saxinger said that maximizes the impact of the expertise we have, from work on diseases such as Ebola, SARS and MERS.
There is also work on coronavirus vaccines using newer, and less tested, approaches called "plug and play" vaccines. Because we know the genetic code of the new coronavirus, Sars-CoV-2, we have the complete blueprint for building it.
Stephen Barr is associate professor of microbiology and immunology who is part of a COVID-19 vaccine development team at at Western University in London, Ont. He noted that the "best" vaccine in the end may not be best for everybody. "But the second one might be, for those that don't respond, right? So it's always good to have these backup vaccines as well or vaccines that can be used in parallel around the world."
The Phase 1 trial is led by Lisa A. Jackson, M.D., senior investigator at KPWHRI. Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100 mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.
For the health care worker study, Neeta teamed up with epidemiologist and microbiologist Marc Bonten of UMC Utrecht. “There is a lot of enthusiasm to participate,” among the workers, Bonten says. The team decided not to use actual infection with coronavirus as the study outcome, but “unplanned absenteeism.” “We don’t have a large budget and it won’t be feasible to visit the sick professionals at home,” Bonten says. Looking at absenteeism has the advantage that any beneficial effects of the BCG vaccine on influenza and other infections may be captured as well, he says.
Next comes testing in humans. Small phase I clinical trials evaluate the safety of the vaccine in humans. During phase II, the formulation and doses of the vaccine are established to prove the vaccine's effectiveness. Finally, during phase III, the safety and efficacy of a vaccine need to be demonstrated in a larger group of people.
Although the study is randomized, participants will likely know if they got the vaccine instead of a placebo. BCG often causes a pustule at the injection site that may persist for months, usually resulting in a scar. But the researchers will be blinded to which arm of the study—vaccine or placebo—a person is in.
It will, almost inevitably, be less successful in older people, because aged immune systems do not respond as well to immunisation. We see this with the annual flu jab.
These are a special class of subunit vaccines, where the proteins are self-assembled into artificial particles that are intended to look like viruses to the human immune system. They bind to and enter cells like a virus, which is different from the way individual protein subunits do.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.
There is also work on coronavirus vaccines using newer, and less tested, approaches called "plug and play" vaccines. Because we know the genetic code of the new coronavirus, Sars-CoV-2, we have the complete blueprint for building it.
Stephen Barr is associate professor of microbiology and immunology who is part of a COVID-19 vaccine development team at at Western University in London, Ont. He noted that the "best" vaccine in the end may not be best for everybody. "But the second one might be, for those that don't respond, right? So it's always good to have these backup vaccines as well or vaccines that can be used in parallel around the world."
The Phase 1 trial is led by Lisa A. Jackson, M.D., senior investigator at KPWHRI. Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100 mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.
For the health care worker study, Neeta teamed up with epidemiologist and microbiologist Marc Bonten of UMC Utrecht. “There is a lot of enthusiasm to participate,” among the workers, Bonten says. The team decided not to use actual infection with coronavirus as the study outcome, but “unplanned absenteeism.” “We don’t have a large budget and it won’t be feasible to visit the sick professionals at home,” Bonten says. Looking at absenteeism has the advantage that any beneficial effects of the BCG vaccine on influenza and other infections may be captured as well, he says.
Next comes testing in humans. Small phase I clinical trials evaluate the safety of the vaccine in humans. During phase II, the formulation and doses of the vaccine are established to prove the vaccine's effectiveness. Finally, during phase III, the safety and efficacy of a vaccine need to be demonstrated in a larger group of people.
Although the study is randomized, participants will likely know if they got the vaccine instead of a placebo. BCG often causes a pustule at the injection site that may persist for months, usually resulting in a scar. But the researchers will be blinded to which arm of the study—vaccine or placebo—a person is in.
It will, almost inevitably, be less successful in older people, because aged immune systems do not respond as well to immunisation. We see this with the annual flu jab.
These are a special class of subunit vaccines, where the proteins are self-assembled into artificial particles that are intended to look like viruses to the human immune system. They bind to and enter cells like a virus, which is different from the way individual protein subunits do.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
This type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.
No comments:
Post a Comment