Volunteerism SARS-CoV-2 vaccine trial?

[SirBillybob]

Would you sign up for a vaccine efficacy study?

 

Let’s assume it was approved based on an acceptable risk of adverse events found in earlier phasing ... that is a given anyway.

 

Let’s also assume it met the necessary ‘warp speed’ required to get to the population-testing stage of development, thereby with reduced knowledge about temporal durability of protection.

 

Finally, let’s assume it is 2:1 ratio in randomized double-blind format, two-thirds recipients vaccine and one-third placebo.

[+ nycman]

No.

[jonnychgo]

I am actually contacting someone about a trial in Chicago. Need a bit more information but a nurse friend of mine is doing it so I think it's safer than assumed.

[coriolis888]

 

 

Would you sign up for a vaccine efficacy study?

 

Finally, let’s assume it is 2:1 ratio in randomized double-blind format, two-thirds recipients vaccine and one-third placebo.

 

 

I do not like the 2:1 ratio chance.

 

If I were to gather enough nerve to volunteer for a vaccine study, I would not want to chance to be in the group that gets a placebo.

Edited June 24, 2020 by coriolis888

[big-n-tall]

If I were absolutely healthy, I think I would. However, I have a few risk factors for the disease. I wouldn't risk it.

[Trick]

If the way to test it is to expose me to a hot escort, I’m in?‍♂️

[SirBillybob]

I just read that older people will not be included in human vaccine trials but the age threshold is not clear. A viable vaccine is possibly less effective for the elderly and one priority will remain vaccinating formal caregivers, younger family members, etc.

 

This seems to pose the conundrum that the effectiveness for seniors will be judged in real time based on peer contagion rather than in prospective research.

 

Sheesh. It all suggests the aged in alternate level of care will need isolation, as a matter of policy, from their fellow inmates to enhance survival.

Edited June 25, 2020 by SirBIllybob

[jonnychgo]

I just read that older people will not be included in human vaccine trials but the age threshold is not clear. A viable vaccine is possibly less effective for the elderly and one priority will remain vaccinating formal caregivers, younger family members, etc.

 

This seems to pose the conundrum that the effectiveness for seniors will be judged in real time based on peer contagion rather than in prospective research.

 

Sheesh. It all suggests the aged in alternate level of care will need isolation, as a matter of policy, from their fellow inmates to enhance survival.

The trial in Chicago mentioned that they were looking for some people 65 and older, however, mainly Black and Latinx populations.

[+ sniper]

I do not like the 2:1 ratio chance.

 

If I were to gather enough nerve to volunteer for a vaccine study, I would not want to chance to be in the group that gets a placebo.

You know it's not like they then stick you in a room of COVID patients to see if you get it? They just tell you to do as you've been doing and compare rates between the groups after a couple of months to see if the vaccine group had a lower rate of infection. So you're either getting the vaccine early or you're not, the latter of which puts you in no worse a position than not being in the study.

[coriolis888]

I just read that older people will not be included in human vaccine trials but the age threshold is not clear. A viable vaccine is possibly less effective for the elderly and one priority will remain vaccinating formal caregivers, younger family members, etc.

 

This seems to pose the conundrum that the effectiveness for seniors will be judged in real time based on peer contagion rather than in prospective research.

 

Sheesh. It all suggests the aged in alternate level of care will need isolation, as a matter of policy, from their fellow inmates to enhance survival.

 

 

The University of Illinois at Chicago to Test Coronavirus Vaccine in New Trial

Researchers at the University of Illinois at Chicago are set to conduct a clinical trial beginning next month

Published June 16, 2020 • Updated on June 16, 2020 at 12:54 pm

 

 

A vaccine aimed at preventing coronavirus infection in those most at risk will be tested on at least 1,000 people in Chicago in a new trial.

 

Researchers at the University of Illinois at Chicago are set to conduct a clinical trial beginning next month using a vaccine developed by biotech company Moderna. The trial will look to determine the efficacy of the vaccine and will be the only site to conduct the trial in Chicago, the university said.

 

“We want to see if the vaccine will prevent people from getting COVID-19 or if it will prevent people from experiencing severe illness if they do get the disease,” Dr. Richard Novak, lead investigator of the clinical trial at UIC, said in a statement.

The study is set to begin July 9, with nearly half the people tested being 65 or older.

 

“We want to test this vaccine in people who are most at risk of experiencing complications and death due to the virus,” Novak said.

 

According to Novak, the clinical trial network hopes to enroll up to 30,000 people, with about 1,000 initially enrolled through UIC’s trial.

 

The test features an RNA-based vaccine, or one designed to help the body produce antibodies that protect against COVID-19.

“RNA vaccines represent a new class of vaccines that researchers hope will be more effective than other types,” Novak said. “The application of this type of innovation to COVID-19 is exciting, although the need for a vaccine of any type against COVID-19 is a pressing and urgent public health necessity.”

 

The trial will separate volunteers randomly into two groups, one of which will receive the vaccine, and the other, a control group, will receive a placebo.

 

Neither the researchers nor the participants will know who gets the vaccine.

 

“This type of randomized, double-blind, placebo-controlled trial is the best way to determine if the vaccine works. We hope that participants who receive the vaccine will have better protection against COVID-19,” Novak said.

 

He noted that volunteers will receive a stipend for their time but did not specify how much that stipend would be.

 

Anyone interested in volunteering should contact UIC researchers at (312) 413-5897 or email ProjectWishDOM@uic.edu.

[+ sniper]

I just read that older people will not be included in human vaccine trials but the age threshold is not clear. A viable vaccine is possibly less effective for the elderly and one priority will remain vaccinating formal caregivers, younger family members, etc.

 

This seems to pose the conundrum that the effectiveness for seniors will be judged in real time based on peer contagion rather than in prospective research.

 

Sheesh. It all suggests the aged in alternate level of care will need isolation, as a matter of policy, from their fellow inmates to enhance survival.

If it dies out in the general population it won't really matter if it's not as effective for the elderly. "herd immunity" happens well before 100% exposure in the population.

[SirBillybob]

So I fact-checked and, indeed, the source on age exclusion (a bioethicist) was incorrect, likely misinterpreting news that older folks (particularly well beyond 65) are formally excluded from some trials underway. Fortunately the clinical watchdogs are strongly advocating for broad age representation. In fact, Phase 2 of Canada’s one approved trial will include up to age 85.

Edited June 25, 2020 by SirBIllybob

[SirBillybob]

If it dies out in the general population it won't really matter if it's not as effective for the elderly. "herd immunity" happens well before 100% exposure in the population.

With less than one percent in Canada’s most affected province to date, I expect artificial immunity is the likelier scenario. Natural immunity would take about 100 reiterations similar to initial wave magnitude. The temporal order is: artificial, I croak unrelated, herd immunity.

Edited June 25, 2020 by SirBIllybob

[+ sniper]

I'm saying herd immunity from the vaccine, even if it doesn't work for you personally. Even the vaccine only works for 60% of the population, if everyone gets it, it doesn't really matter if you are one of the 40% it doesn't work for, the population spread will most likely have been halted.

[Guest]

If I were in the area, I'd volunteer.

[SirBillybob]

I'm saying herd immunity from the vaccine, even if it doesn't work for you personally. Even the vaccine only works for 60% of the population, if everyone gets it, it doesn't really matter if you are one of the 40% it doesn't work for, the population spread will most likely have been halted.

Gotcha. [survival immunity plus minimum direct vaccine-conferred herd volume immunity] plus non/fail-vaxx’d indirect protection via reduced transmission vector all potentially lowers or eradicates infection.

Edited June 25, 2020 by SirBIllybob

[SirBillybob]

I think I am a poor trial candidate because my current “behave as usual” set point is extremely low risk of exposure. I realize that does not disqualify me because a gradient of exposure risk among subjects is acceptable, but I am willing to trade off a lot of non-normalcy duration for the possibility of increased qualitative aspects of vaccination that may occur over time.

 

The study in Canada is a China-Canada collaboration, Canada lagging behind in the Phase progression and, I add hopefully, isolated from the politics of a current reciprocal detention standoff. Preliminary results of human application in China suggest side effects (beyond site infection) that will indirectly unblind many subjects‘ awareness of group allocation.

[SirBillybob]

Months ago the Canada-China collab based in Nova Scotia collapsed over political issues.

———-

 

Dozens of vaccine candidates have lost the likelihood of sufficiently recruiting for Phase 2/3 trials because they would require volunteer commitments of time that may exceed the distribution of the few promising vaccines that people will be eager to take if available.

 

I am trying to volunteer for the first candidate that is recently approved in Canada along with a likely Montreal study location, but now I have second thoughts, as the company likely has as well.

 

Following huge sums of government money thrown at vaccine research there is likely tension between funding for research/development and massive production/distribution.

 

Much will depend on future incidence rates versus approved vaccines reaching everybody.