Good news regarding the norovirus vaccine!

[SoVerySorry]

I'll post the link here. I'll also post the text underneath the link to ease stress on phones or computers that aren't as speedy.

http://www.medpagetoday.com/MeetingC...e/IDWeek/42101



TEXT
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SAN FRANCISCO -- A bivalent norovirus vaccine protected patients against severe vomiting and diarrhea symptoms, as well as viral shedding, researchers reported here.
Compared with patients treated with placebo in a phase I/II trial of the vaccine, no patients who received the norovirus vaccine reported severe vomiting and/or diarrhea (0% versus 8.3%), and norovirus symptom severity was significantly reduced among those in the treatment group (20% versus 41.7%, P=0.028), according to David Bernstein, MD, of Cincinnati Children's Hospital Medical Center in Ohio, and colleagues.
At 10 days after receiving the vaccine, fewer patients shed the virus (22.4% versus 36.2%), though this difference was not significant, Bernstein said at a press conference during theIDWeek meeting.
Earlier at the meeting, researchers from the CDC reported data showing that norovirus was the most common cause of acute gastroenteritis in the U.S., from 2009 to 2010, even withoutoutcomes reported from cruise ships. Norovirus is also becoming increasingly common -- and associated with all-cause mortality and hospital admissions -- in nursing homes, according toCDC data from last year's IDWeek meeting.
Bernstein and colleagues tested a bivalent norovirus vaccine in a population of 98 adults who were otherwise healthy and intentionally infected with norovirus as part of the randomized, double blind, multicenter, placebo-controlled human challenge trial.
The vaccine was formulated against the GI.1 and GII.4 virus strains, which respectively represent roughly 10% and 64% of strains seen, Bernstein said, adding that "one of the challenges with norovirus and the norovirus vaccine is the diversity of viral strains."
Participants received either two inoculations with vaccine at 28 days apart or placebo, and then received 4,400 RT-PCR units of the GII.4 challenge virus at 56 days from baseline. They were monitored in an inpatient ward for 4 days with no outside contact.
Study endpoints included safety, immunogenicity, and efficacy, which included measures of viral shedding in stool and after 30 days from receiving the virus.
Symptoms were recorded for 4 days after the virus was introduced. Patients self-reported symptom severity.
Moderate to severe symptoms occurred in 6% of patients who were vaccinated versus 18.8% of those who received placebo, though this difference was not significant. Mild, moderate, or severe symptoms occurred in 18% of patients who were vaccinated versus 37.5% of those who receive placebo, which was significant (P=0.042).
Bernstein cautioned that these results were preliminary and that real-world settings would be the next place to test the vaccine. He also said that his team didn't know the length of time the vaccine produced immunity for, adding that "norovirus doesn't change as frequently as the flu, so we hopefully won't need to revaccinate patients every year."
"If we achieve herd immunity and we're exposed to fewer norovirus over our lifetime, we may not need to be boosted as frequently so time will tell," pointed out Andrew Pavia, MD, of the University of Utah Health Care in Salt Lake City.
"The short-term benefits [of the vaccine] are very attractive, even if it doesn't alter long-term susceptibility or lead to the extinction of some of these viruses," added Pavia, who served as session moderator.
Bernstein noted that the four-fold rise in serum antibodies from pre-to-post virus introduction "was an inadequate test for infection" and that it was not achieved in 11 subjects who experienced gastroenteritis. Additionally, viral shedding did not predict symptomatic disease. Finally, the definition of illness that included quality and quantity of vomiting or diarrhea did not align with clinical evaluations of disease.
The study was supported by Takeda Pharmaceufical Company.
The authors received support from LigoCyte, Takeda Vaccines, and the University of Rochester in Rochester, N.Y. Some co-authors are employees of Takeda.

[Syrup]

I never fully understand these sorts of reports. I know that this is good news based the on the enthusiasm with which it's written, but I don't understand the statistics. At the beginning of the article is said that 0% of patients experienced d* o v* who'd had the actual vaccine. Later in the article is said that moderate to severe symptoms occurred in 6% of patients and mild, moderate or severe symptoms occurred in 18% of patients. Was that with the 2nd round of the vaccine? Now the earlier articles indicated that this vaccine was expected to give everyone 98% immunity. I know that they are still working and that these are just early stage results, but the fact that close to 20% were still having symptoms doesn't thrill me. No matter what I'll be in line with my family for the vaccine once it's out, 80% chance of no symptoms IF you catch the virus sounds pretty great to me, I was just really hopeful for a higher %.

[paulinek]

Who the hell volunteers to take part in a trial like that?!!! And how much do they get paid, i mean, even non emets detest norovirus so why on earth would you put yourself through that? Mind you, i'm glad there ARE people like that as without them we may never get an effective vaccine. So long as there was absolutely zero chance of getting even the mildest symptoms of noro then i would also have the vaccine, i would still worry about it but would definitely feel a bit more confident of my chances of avoiding it than I do now.

[Grace47]

They lost me at extinct. I was so happy to have the word "extinct" and "norovirus" used in the same sentence my brain just skipped off to it's happy place.

[SoVerySorry]

I think they were payed 750-1,400 US Dollars for the trials. The money is good and all, but yea nope haha!

[Jglover]

I think they were payed 750-1,400 US Dollars for the trials. The money is good and all, but yea nope haha!

Does anyone know when this vaccine is suppose to be available to the public?

[gumdropper1]

Who the hell volunteers to take part in a trial like that?!!!

To the average person, puking is not a big deal. They are willing to do it for the money that is offered. Anyway, this study was done with patients staying in a hospital for 4 days, so they probably got paid at least $100 per day. Most non-emets would be willing to puke for $400. Doug

[JadeNight]

I feel like the scariest part of it is not knowing the "ifs" and "whens" of norovirus. With the given conditions that I feel like if I KNEW I was injected with it, if I was contained in a safe controlled environment (a hospital as stated these trial members were) instead of being at work or out in public, and was paid a sum of money between those amounts to maybe show symptoms, then I'd consider it. Then again, I'm doing a lot better with my emet than most on this site. I could get reamed for this but I've thought about it all night with the consideration that I'm avoiding my mothers house at the moment because she has been sick with a stomach bug, and a couple co-workers have come down a stomach bug.

But would I get the vaccine when it's out of trial and in the public like the seasonal flu vaccine? No. I am wary on even getting my flu shot because I don't enjoy the malaise feelings the following days but my doctor is strongly suggesting it because of asthmatic I am.

[SoVerySorry]

I think I read that there wouldn't be effects similar to attenuated vaccines because the vaccine doesn't attack the lining of the stomach to cause temporary immunity. It is a nasal spray vaccine? I'll try to find the link but I'm sorry if i can't find it.

[jptk]

I feel like the scariest part of it is not knowing the "ifs" and "whens" of norovirus. With the given conditions that I feel like if I KNEW I was injected with it, if I was contained in a safe controlled environment (a hospital as stated these trial members were) instead of being at work or out in public, and was paid a sum of money between those amounts to maybe show symptoms, then I'd consider it. Then again, I'm doing a lot better with my emet than most on this site. I could get reamed for this but I've thought about it all night with the consideration that I'm avoiding my mothers house at the moment because she has been sick with a stomach bug, and a couple co-workers have come down a stomach bug.

But would I get the vaccine when it's out of trial and in the public like the seasonal flu vaccine? No. I am wary on even getting my flu shot because I don't enjoy the malaise feelings the following days but my doctor is strongly suggesting it because of asthmatic I am.

Agree with most of this. Carrying on and going to work, going out for meals or pretty much anything involving leaving the house would be very difficult knowing you could possibly come down with symptoms. Also, I think not knowing whether you are in the placebo group or not would make it harder...

[Kazzia]

On reading the article it does seem there is still some progress to be made, considering we're only in phase I and II here, and the results at phase III are going to have to be good if the vaccine has any chance of making it to market - if it fails at phase III then I'm guessing it will be back to the drawing board. However it's encouraging that they are working hard to develop a vaccine, given that norovirus is increasingly common, and dangerous amongst vulnerable groups. I think it would be very popular!

I think the people who take part in these trials need a medal. Non emets I know who have had norovirus have said things to be like "hell on earth" and "never again" from their noro experiences, and these are the kind of people who are OK with getting drunk and v*ing or just being sick from other causes. To be honest I'd struggle to think of many non emets I know who would volunteer to be injected with norovirus, although the controlled, safe environment and the money would probably swing it for them.

Stick another seven zeros onto the payment sum and I still wouldn't do it. I can't think of anything more terrifying and I wouldn't do it for any amount of money, even under that sort of medical supervision. I'd happily be a guinea pig for other things but definitely not this!

[Syrup]

I'm just glad that the cruise ship companies are pouring so much money into Takeda to get this vaccine to be as successful as possible! I thought that based on articles they released in July it was going to be close to 98% resistance. Fingers crossed that they find a way to get a higher success rate!