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posted by martyb on Tuesday September 18 2018, @04:25AM   Printer-friendly
from the what-could-possibly-go-wrong? dept.

In 2016, as the mosquito-borne Zika virus spread through the Americas and cases of infected women having brain-damaged babies mounted, investigators raced to develop a vaccine. Now, a $110 million vaccine trial is underway at 17 sites in nine countries, but it faces an unexpected, and ironic, challenge. Cases of Zika have plummeted to levels so low that most people vaccinated in the trial likely will never be exposed to the virus, which could make it impossible to tell whether the vaccine works.

"Right now, there are no infections, and certainly not enough to even think about an efficacy signal at this point," says Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, which launched the trial. Human trials of other Zika vaccine candidates at earlier stages are also in limbo, and last year one large vaccinemaker pulled the plug on development of its candidate. But NIAID and others are pressing ahead, saying a vaccine might someday be needed. To make up for the lack of new cases, other investigators are turning to an unusual, and ethically complex, strategy. Starting next year, Science has learned, they plan to test a vaccine by deliberately infecting people with Zika.

Launched in March 2017, NIAID's placebo-controlled vaccine trial includes two sites in Brazil, where Zika hit hardest and where the brain damage known as microcephaly first surfaced. From the beginning of the outbreak in 2015 until the start of this year, Brazil had about half of all 800,000 suspected and confirmed Zika cases in the Americas, according to the Pan American Health Organization in Washington, D.C. But from January through June, Brazil's Ministry of Health reported fewer than 7000 probable cases, in a nation of 200 million people. "It's a good dilemma because we don't have Zika anymore," says Esper Kallás of the University of São Paulo in São Paulo, Brazil, principal investigator for the local NIAID site. "But it's a dilemma. Everybody is concerned about it. It's a lot of investment."

[...] Given the drop in cases, a surer way to test any vaccine against Zika is to deliberately expose inoculated subjects to the virus. Researchers have used this strategy, known as a human challenge trial, for decades to test vaccines against diseases that either can be effectively treated or, like Zika, typically cause mild symptoms.

But in 2017, an ethics committee convened by NIAID and the Walter Reed Army Institute of Research in Silver Spring, Maryland, called it "premature" for Zika. They worried that people intentionally infected with the virus might transmit it to their sexual partners, primarily through infected semen. And they were confident that traditional field trials could test the efficacy of the leading vaccine candidates.

[...] Now, the study is being considered again, as Zika disappears from the region and industry loses interest in bringing a vaccine to market. In a major blow, Sanofi Pasteur halted work on its vaccine, licensed from Walter Reed, in September 2017. "There's a compelling reason to conduct a human challenge trial now," says bioethicist Seema Shah of Northwestern University's Feinberg School of Medicine in Chicago, Illinois, who chaired the 2017 ethics committee. But, she adds, "The details are complicated and it's important to have a rigorous review."

"If they're careful, we have no problems supporting it," Fauci says. Durbin plans to submit her new protocol for review in about a month, and in early 2019 hopes to start injecting Zika virus into people immunized with a vaccine containing live, but weakened Zika virus made by NIAID's Stephen Whitehead. As a precaution, she plans to enroll only women at first, to avoid semen transmission from infected males. The volunteers will receive a low dose of Zika virus, and they will remain in clinics for the 2 weeks it typically takes to clear the infection. Any vaccine that works in the challenge study theoretically could then be evaluated in a real-world outbreak—just as is occurring now with an unlicensed but promising Ebola vaccine.

doi:10.1126/science.aav3996

-- submitted from IRC


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  • (Score: 1) by realDonaldTrump on Tuesday September 18 2018, @04:37AM (2 children)

    by realDonaldTrump (6614) on Tuesday September 18 2018, @04:37AM (#736378) Homepage Journal

    But they want vaccine. So they want to make people sick for the vaccine. Everything you need to know about vaccine can be understood by this simple phrase: follow the money!!!

    • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @06:29PM (1 child)

      by Anonymous Coward on Tuesday September 18 2018, @06:29PM (#736643)

      Gotta remember to read the author name first!

  • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @05:11AM (9 children)

    by Anonymous Coward on Tuesday September 18 2018, @05:11AM (#736388)

    the brain damage known as microcephaly

    Micrencephaly is brain damage, microcephaly is only loosely correlated with it. In fact microcephaly while a fetus is only loosely correlated with microcephaly as a new born which is only loosely correlated with microcephaly as a child, etc. How many parents got abortions due to this false info?

    Dont feel like going over it all again but that and more (the crappy blood tests theyre using) are discussed here:

    https://soylentnews.org/comments.pl?cid=352679&sid=13799 [soylentnews.org]
    https://soylentnews.org/comments.pl?cid=440402&sid=16949 [soylentnews.org]
    https://soylentnews.org/comments.pl?cid=512192&sid=19586 [soylentnews.org]
    https://soylentnews.org/comments.pl?cid=524936&sid=20018 [soylentnews.org]

    • (Score: 0, Disagree) by Anonymous Coward on Tuesday September 18 2018, @05:25AM (8 children)

      by Anonymous Coward on Tuesday September 18 2018, @05:25AM (#736392)

      Here is probably the most informative of the posts:
      https://soylentnews.org/comments.pl?noupdate=1&sid=20018&page=1&cid=525082#commentwrap [soylentnews.org]

      • (Score: 2) by FatPhil on Tuesday September 18 2018, @10:04AM (7 children)

        by FatPhil (863) <pc-soylentNO@SPAMasdf.fi> on Tuesday September 18 2018, @10:04AM (#736446) Homepage
        And all such posts would have been given far better readership if the pinhead who wanted the information to be broadly known had gone to the effort of posting whilst logged into an account. He or she, by chosing to post as A/C was deliberately limitting his or her own readership.
        --
        Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves
        • (Score: -1, Troll) by Anonymous Coward on Tuesday September 18 2018, @01:18PM

          by Anonymous Coward on Tuesday September 18 2018, @01:18PM (#736491)

          Its not like there is any chance they will stop with their zika scam anyway. People want to be scammed by healthcare workers, they keep giving them more and more money.

        • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @02:57PM (5 children)

          by Anonymous Coward on Tuesday September 18 2018, @02:57PM (#736536)

          That's because this specific AC is a conspiracy theorist that always trolls the medical and CRISPR stories.

          This AC has single-handedly exposed the worldwide conspiracy of biologists and doctors to scam everyone about everything. The AC was apparently a biology grad student that still has hurt feelings over the experience and is on a crusade to discredit the field by cheerypicking pubmed articles they don't understand.

          • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @08:44PM (4 children)

            by Anonymous Coward on Tuesday September 18 2018, @08:44PM (#736719)

            What not point out which aspect of micocephaly/micrencephaly mentioned I am wrong about? Instead you just make vague accusations...

            • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @09:20PM (3 children)

              by Anonymous Coward on Tuesday September 18 2018, @09:20PM (#736738)

              If you posted with an account, then your troll crusade would be obvious.

              Why don't you just tell us again how CRISPR/Cas9 is a scam and all the results that provide evidence for the mechanism of gene editing are falsified or the scientists are just too incompetent to know better?

              • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @10:24PM (2 children)

                by Anonymous Coward on Tuesday September 18 2018, @10:24PM (#736780)

                Because this thread has nothing to do with crispr/cas9...

                Anyway you don't find anything wrong with what I've shared about microcephaly/micrencephaly? It seems pretty straightforward to me, but how do you explain all these news stories that ignore the basic distinction? Why don't they ever report a link between zika infection and the actual disease: micrencephaly?

                • (Score: 0) by Anonymous Coward on Wednesday September 19 2018, @04:03AM (1 child)

                  by Anonymous Coward on Wednesday September 19 2018, @04:03AM (#736908)

                  Oh, did you finally give up the whole "Cas9 doesn't do anything besides kill cells" thing?

                  • (Score: 0) by Anonymous Coward on Wednesday September 19 2018, @10:36AM

                    by Anonymous Coward on Wednesday September 19 2018, @10:36AM (#736969)

                    So posts supported by multiple research journal refs are trolling, but unsupported accusations and trying to change the subject is fine.
                    If you want my opinion on gene editing submit an article on that topic, preferably one about some fresh data.

  • (Score: 0, Troll) by Anonymous Coward on Tuesday September 18 2018, @05:48AM (10 children)

    by Anonymous Coward on Tuesday September 18 2018, @05:48AM (#736399)

    Infect white males to test the vaccine, they are useless for any other purpose anyway.

    • (Score: 2, Flamebait) by aristarchus on Tuesday September 18 2018, @06:10AM (6 children)

      by aristarchus (2645) on Tuesday September 18 2018, @06:10AM (#736403) Journal

      Infect white males to test the vaccine

      Exactly! Great minds think alike, no? Now as for "volunteers": I suggest TMB, VLM, mostly because they are TLAs, and Runaway1956, because he is a date, and jmorris, well, just because. None of these fine specimens of White masculinity are in danger of suffering further from micro-encephally, given the extraordinarily small size of their intellectual capacity, which suggests, but does not necessarily indicate, a smaller cranial capacity. In either case, no harm can be expected, and the benefits to humanity at large are enormous. "The Needs of the Many outweigh the need of the Few, or in this case, of the TMB." Star Trek: a Movie? Wrath of Khan? OMG, TMB believes his is Khan Noonien Singh? But it is "dot", not "feather"! Oh, the Huge manatee, currently affect by red tide and Hurricane Flo.

      • (Score: -1, Offtopic) by Anonymous Coward on Tuesday September 18 2018, @06:21AM (4 children)

        by Anonymous Coward on Tuesday September 18 2018, @06:21AM (#736405)

        You got it wrong, small brain is usually associated with a small head, but not the reverse (at least using the 2 sd definition of "small" they came up with for microcephaly).

        • (Score: 3, Informative) by aristarchus on Tuesday September 18 2018, @06:35AM (3 children)

          by aristarchus (2645) on Tuesday September 18 2018, @06:35AM (#736407) Journal

          Of course you are correct, but we are not dealing with standard deviants here, but four radically deviant individuals, so the stats do not necessarily conform to the specific instances. We do not want to commit the Fallacy of Accident [wikipedia.org] here. Or do we? State your originary stance, AC. From whence do you argue?

          • (Score: -1, Offtopic) by Anonymous Coward on Tuesday September 18 2018, @06:53AM (2 children)

            by Anonymous Coward on Tuesday September 18 2018, @06:53AM (#736409)

            I used to have more respect for aristotle, then learned he said beavers were a type of fish. Whats the name for that fallacy?

            • (Score: 3, Insightful) by aristarchus on Tuesday September 18 2018, @07:16AM

              by aristarchus (2645) on Tuesday September 18 2018, @07:16AM (#736414) Journal

              Aristotle said many things, much of them wrong. For example, he said turtles would always eat marjoram after eating snakes [google.ch], most obviously not true. And he held that Lionesses could only gestate decreasing numbers of offspring:

              . A similar condition is the cause of the later sterility of the lioness, for at the first birth she produces five or six, then in the next year four, and again three cubs, then the next number down to one, then none at all, showing that the residue is being used up and the generative secretion is failing along with the advance of years.

              Again, obviously untrue.

                So what is your point about the atypical smallness of intellect by the aforementioned deviant Soylentils, and the disputed correlation to cranial capacity? I am confused by your attempt to Red Herring the Question to Aristotle, whom we were not discussing.

            • (Score: 4, Informative) by maxwell demon on Tuesday September 18 2018, @07:28AM

              by maxwell demon (1608) on Tuesday September 18 2018, @07:28AM (#736418) Journal

              Whats the name for that fallacy?

              You mean the fallacy of applying modern categories to judge ancient statements?

              Historically, "fish" meant "animal that lives in the water". Today we use a different definition, that is more in line with out better knowledge of biology. That doesn't invalidate the old statement, it just means that the term "fish" used in it is not the same as the term "fish" used today (of course Aristotle did never say "fish" to begin with, because he was speaking ancient Greek; "fish" is just the English word which has the largest semantic overlap with the ancient Greek word he used).

              --
              The Tao of math: The numbers you can count are not the real numbers.
      • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @07:17AM

        by Anonymous Coward on Tuesday September 18 2018, @07:17AM (#736415)

        and jmorris, well, just because

        Because he's hailing from beau.org. Good enough in my books.

    • (Score: 2) by maxwell demon on Tuesday September 18 2018, @07:21AM (2 children)

      by maxwell demon (1608) on Tuesday September 18 2018, @07:21AM (#736416) Journal

      Infect white males to test the vaccine, they are

      most effective in spreading it.

      From the summary:

      They worried that people intentionally infected with the virus might transmit it to their sexual partners, primarily through infected semen.

      Which sex produces semen, again?

      --
      The Tao of math: The numbers you can count are not the real numbers.
      • (Score: 2) by c0lo on Tuesday September 18 2018, @07:50AM

        by c0lo (156) Subscriber Badge on Tuesday September 18 2018, @07:50AM (#736422) Journal

        Which sex produces semen, again?

        Runaway1956... by his very nature of being a self-confessed seaman... I reckon it's seaman stains all around him

        (large grin)

        --
        https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
      • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @07:59AM

        by Anonymous Coward on Tuesday September 18 2018, @07:59AM (#736424)

        Exactly. And what color is semen?

  • (Score: 0) by Anonymous Coward on Tuesday September 18 2018, @05:37PM

    by Anonymous Coward on Tuesday September 18 2018, @05:37PM (#736611)

    Or the corporate giants that employ them?

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