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First Commercial HIV Vaccine On Horizon After Successful Human Trial

VaccineAn HIV vaccine has proven successful in a Phase I clinical trial with no adverse effects on human patients. The vaccine, developed by Dr. Chil-Yong Kang and his team at Western’s Schulich School of Medicine & Dentistry, with the support of Sumagen Canada, is the first genetically modified, whole-killed vaccine to be approved for testing in humans.

“We are now prepared to take the next steps towards Phase II and Phase III clinical trials,” Sumagen CEO Jung-Gee Cho said in a press release. “We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine.”

This vaccine was used in human clinical trial to evaluate its safety, tolerability and immune responses from March 2012 through August 2013:

This trial was a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. HIV-infected, asymptomatic men and women, 18 to 50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo…No serious adverse event was observed in any volunteer vaccines throughout the observation periods.

Sumagen will now proceed with Phases 2 and 3 clinical trials to show the immunogenicity and efficacy of the vaccine and the pharmaceutical company plans on having not only “the first HIV vaccine in market but also the eradication of HIV/AIDS for human beings.”

h/t: Medical Daily

By:           Les Fabian Brathwaite
On:           Sep 5, 2013
Tagged: , ,

  • 31 Comments
    • NateB79
      NateB79

      This is pretty incredible.

      Sep 5, 2013 at 9:19 am · @ReplyReply to this comment ·
    • Katbox
      Katbox

      Good news for HIV+ individuals.
      Bad news for pharmaceuticals looking to suck them dry.

      Let’s see what happens.

      Sep 5, 2013 at 9:22 am · @ReplyReply to this comment ·
    • QJ201
      QJ201

      Call me when it gets to Phase III…since so many of the previous vaccine trials failed in Phase II and some have had Phase III ended due to lack of results or unintended consequences.

      Sep 5, 2013 at 9:30 am · @ReplyReply to this comment ·
    • Dakotahgeo
      Dakotahgeo

      Another modern miracle (hopefully) that will make the religious extremists pee their panties an fill their Depends prematurely, and save lives! I will be so happy for the recipients!

      Sep 5, 2013 at 9:33 am · @ReplyReply to this comment ·
    • viveutvivas
      viveutvivas

      This seems to be a therapeutic vaccine for HIV+ individuals, not a preventive vaccine as one normally thinks of a vaccine.

      And unfortunately many vaccines have worked well in phase I trials (i.e., safety trials) causing a good immune response, yet all have been quite ineffective.

      Sep 5, 2013 at 9:35 am · @ReplyReply to this comment ·
    • Tookietookie123
      Tookietookie123

      @QJ201: Nonetheless, we still have to have hope for a vaccine, if not for ourselves then for the millions of lives it could save in the long run.

      Sep 5, 2013 at 9:38 am · @ReplyReply to this comment ·
    • Dakotahgeo
      Dakotahgeo

      @viveutvivas: We can always hope. :-)

      Sep 5, 2013 at 9:38 am · @ReplyReply to this comment ·
    • GayTampaCowboy
      GayTampaCowboy

      I read the press release and Dr. Sumagen said he “anticipates not only having the first HIV vaccine in market but also the eradication of HIV/AIDS for human beings.”

      Hopefully these researchers have a TIGHT HOLD on the Phase II and III testing process so we don’t get any “big pharma” agents trying to skew the results!

      Sep 5, 2013 at 9:48 am · @ReplyReply to this comment ·
    • Thomathy
      Thomathy

      @Katbox:

      Good news for HIV+ individuals.
      Bad news for pharmaceuticals looking to suck them dry.

      Let’s see what happens.

      This is a vaccine. It is prophylactic. It is meant to be used in people who are not HIV+ to prevent infection.

      @viveutvivas:

      This seems to be a therapeutic vaccine for HIV+ individuals, not a preventive vaccine as one normally thinks of a vaccine.

      It’s a vaccine. It’s in the press release. Also ‘therapeutic vaccine’ doesn’t mean what you think it means.

      @GayTampaCowboy:

      I read the press release and Dr. Sumagen said he “anticipates not only having the first HIV vaccine in market but also the eradication of HIV/AIDS for human beings.”

      Hopefully these researchers have a TIGHT HOLD on the Phase II and III testing process so we don’t get any “big pharma” agents trying to skew the results!

      LOL Wut? You definitely didn’t read the press release.

      There is a Dr. Chil-Yong Kang. There is no Dr. Sumagen. That’s Sumagen Canada, a ‘big pharma’ biotech company. The university is already working with ‘big pharma’. And Sumagen Canada is paraphrased in the press release as having said, ‘anticipates not only having the first HIV vaccine in market but also the eradication of HIV/AIDS for human beings.’

      Sep 5, 2013 at 10:11 am · @ReplyReply to this comment ·
    • Roger Rabbit
      Roger Rabbit

      Phase 1 Clinical Trials are to make sure the drug does not harm anyone, and gathers the beginning list of side effects.

      It does NOT test to see if the drug actually says what it is going to do.

      So releasing this study at this time was simply a way to hype the drug to raise collaborative efforts and potentially funds for the furthering of Phase 2 and potentially Phase 3 Clinical Trials.

      It takes over a billion dollars to get a drug through all three phases of clinical trials, and that is with a narrow scope such as this. Let’s hope that this drug makes it through all 3 phases and can finally be a preventative measure to eradicate this disease. But I’m not holding my breath until it gets through at LEAST Phase 2.

      Sep 5, 2013 at 11:12 am · @ReplyReply to this comment ·
    • Bozen
      Bozen

      Interesting news, but I wonder what the implications could be regarding the resurgence of anonymous/rampant unsafe sex if the vaccine goes through

      Sep 5, 2013 at 11:37 am · @ReplyReply to this comment ·
    • hyhybt
      hyhybt

      @Bozen: That’s happening anyway.

      Sep 5, 2013 at 12:10 pm · @ReplyReply to this comment ·
    • Katbox
      Katbox

      @Bozen: apparently a lot of people are already having it.

      Dustin Lance Black…..

      Sep 5, 2013 at 12:59 pm · @ReplyReply to this comment ·
    • 1EqualityUSA
      1EqualityUSA

      hyhybt, and let’s not forget those special gay rings filled with stuff….

      Sep 5, 2013 at 1:00 pm · @ReplyReply to this comment ·
    • Polaro
      Polaro

      @Bozen: That’s the idea.

      Sep 5, 2013 at 1:17 pm · @ReplyReply to this comment ·
    • Randy
      Randy

      I still feel no hope.

      Sep 5, 2013 at 1:50 pm · @ReplyReply to this comment ·
    • viveutvivas
      viveutvivas

      @Thomathy, so what do you think “therapeutic vaccine” means?

      Sep 5, 2013 at 2:41 pm · @ReplyReply to this comment ·
    • akn
      akn

      @Thomathy: You’re right that this is a preventive vaccine, but I’m curious as to what your understanding of a “therapeutic vaccine” is, vis-a-vis your comment directed at viveutvivas. Are you able to clarify? Thanks.

      Sep 5, 2013 at 2:42 pm · @ReplyReply to this comment ·
    • Thomathy
      Thomathy

      Viveutvivas, Akin, a therapeutic vaccine would be a vaccine meant to cure (treat) a chronic infection. They don’t operate at all like a vaccine in the traditional sense, and are being developed currently for use against cancers, tuberculosis (and other bacteria) and, yes, even against HIV (and other viruses). The use of the word therapeutic is misleading, but it’s used because an infection is present already and because the vaccine is stimulating an immune response to a present infection (it is a therapy, if curative). It is necessary to draw a distinction from a typical vaccine as the purpose and action of a therapeutic vaccine is quite different.

      If that’s what you did mean, sorry. People tend to bandy the term about without much understanding, as though it would be a lifelong treatment for a chronic illness rather than curative. Of course, with HIV, eradication of the virus in vivo isn’t likely to be possible, so any so-called therapeutic vaccine would be stretching the definition quite a lot and would essentially be a (possibly) one-time treatment for an infection that would be contained and managed, but still persist.

      Sep 5, 2013 at 3:22 pm · @ReplyReply to this comment ·
    • Thomathy
      Thomathy

      *Akn, sorry.

      Sep 5, 2013 at 3:22 pm · @ReplyReply to this comment ·
    • mlbumiller
      mlbumiller

      @viveutvivas:
      Does anyone ever read the links? Nothing in the press release stating that SAV001-H is a therapeutic vaccine, in fact the release states the goal is a preventative vaccine. This is the problem with just cutting and pasting a couple paragraphs.

      “In addition to safety evaluation, HIV-1 specific antibody detections have been performed throughout the follow up period. The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees and antibody against gp120 surface antigen increased up to eight-fold after vaccination. The increased antibody titers were maintained during the 52 week study period. The boost antibody production in HIV-positive volunteer vaccinees is highly encouraging, since it forecasts a success of the Phase 2 human clinical trial, which will measure the immune responses.

      In particular, the antibody against gp120 surface antigen is considered to be very important, since some of these antibodies may represent the broadly neutralizing antibodies, which seem to be the most important parameter of an effective HIV vaccine for prevention of HIV-infection.

      SAV001-H is the first genetically modified killed whole virus vaccine (SAV001-H) in human clinical trial and proving its safety was the major concern for going forward for next steps. With these encouraging results from the Phase I Clinical Trial, Sumagen is confident in developing SAV001-H as the first preventative HIV vaccine for saving millions of lives and is now preparing for the next phases of trials to show the immunogenicity and efficacy.”

      Sep 5, 2013 at 3:58 pm · @ReplyReply to this comment ·
    • Brian
      Brian

      HIV does not cause AIDS. A vaccine is pointless. Anti-viral drugs are pointless.

      Stop being promiscuous and stop taking drugs – best cure for AIDS ever.

      Sep 5, 2013 at 4:24 pm · @ReplyReply to this comment ·
    • Thomathy
      Thomathy

      @Brian:

      HIV does not cause AIDS. A vaccine is pointless. Anti-viral drugs are pointless.

      Stop being promiscuous and stop taking drugs – best cure for AIDS ever.

      Those are dangerous lies

      Sep 5, 2013 at 4:32 pm · @ReplyReply to this comment ·
    • hyhybt
      hyhybt

      @Brian: If not by spreading HIV, by what specific mechanism do you propose that promiscuity and drug-taking cause AIDS? (Also, I can’t help noticing you use the word “cure,” yet it’s very plain that ceasing to be promiscuous and to take drugs does not cause AIDS to go away once established.)

      Sep 5, 2013 at 4:32 pm · @ReplyReply to this comment ·
    • the other Greg
      the other Greg

      @Brian: Hey Brian, your boyfriend is fucking around on you!

      (Is that why your Facebook is down?)

      Sep 5, 2013 at 5:03 pm · @ReplyReply to this comment ·
    • MikeE
      MikeE

      @Brian: so is it specifically the combination of promiscuity AND drugs? or does doing drugs alone also cause AIDS? how much promiscuity is enough for the disease to develop?

      Would one joint be enough “drugs” to cause AIDS? how about a single sexual partner? Do you have to do the drugs before, during or after sexual intercourse for AIDS to develop?

      These are all important questions for you to answer if we are to live good lives and not catch the AIDS.

      By the way, I never did drugs, and had my first sexual encounter – a steady boyfriend, who didn’t know his previous BF had cheated on him – when I became HIV+. So how does your theory about AIDS being contracted through promiscuity and drugs fit into that particular scenario?

      If it isn’t a virus, then technically, my BF’s previous BF couldn’t have “given him” anything, since AIDS is caused by poor living, according to you. Since I wasn’t promiscuous, and didn’t do drugs, then how do you explain the HIV infection and subsequent HIV-related illnesses I got?

      HIV-deniers are such a funny lot. They deny, deny, deny, yet can never come up with anything that isn’t half-baked and nonsensical when pressed to explain AIDS. I’m sure that all of those babies who died of AIDS were very promiscuous before birth, doing lots of drugs and going to raves!

      /facepalm

      Sep 5, 2013 at 6:26 pm · @ReplyReply to this comment ·
    • boring
      boring

      Call me when they get to Phase IV, which is when the ants start taking over the world.

      Sep 5, 2013 at 6:31 pm · @ReplyReply to this comment ·
    • redcarpet
      redcarpet

      I hope its the vaccine we’ve all been hoping for, but I am extremely pessimistic. Even if it is shown to be effective, it won’t be 100 percent. Hell, it probably won’t even be 80 percent. We’ve been jerked around so many times before so I don’t see a real vaccine happening in my lifetime.

      It would sure be nice to not have the pendulum of HIV swinging over our sex live though. Real nice.

      Sep 5, 2013 at 7:02 pm · @ReplyReply to this comment ·
    • patricklee5150
      patricklee5150

      AWESOME!

      Sep 5, 2013 at 9:28 pm · @ReplyReply to this comment ·
    • Hermes
      Hermes

      @viveutvivas:

      Actually, despite the support of Jonas Salk (then still alive) the man who cured Polio — a standard killed virus vaccine has NEVER been tried on HIV. He was excoriated for suggesting that it might work, and funding was pulled. Articles in the journals said mostly that he “was old” “didn’t understand anymore” and “couldn’t be bothered to study” (the differences between viruses and retroviruses.) He went to his grave insisting that the idea was the same. Vaccines tried on HIV that some publications said were killed virus were ACTUALLY virus fragments, recombined. The Salk Institute did develop a “therapeutic vaccine” – but it isn’t a vaccine in classic senses, being instead a concentrate of certain immunoglobulins and proteins from the patient, and it was developed by the Institute after the flap over Dr. Salk’s position on HIV vaccination had died down.

      If this works, and I have long supported the idea of at least engaging in trials of a killed virus vaccine – then I think there are MANY hard questions that need to be asked, starting with why this was not tried when he proposed it? Was it onus against the LGBT community? Was it a desire to make money? Was it (most likely) professional arrogance? Believe me, I will start asking some of those questions of some of my own colleagues – if this works.

      Regards.

      Sep 5, 2013 at 10:33 pm · @ReplyReply to this comment ·
    • viveutvivas
      viveutvivas

      I believe the classical objection to killed/inactivated whole virus vaccines is the lack of guarantee that the virus is completely dead. There is a small chance viral particles can recombine into active virus. This is not just theoretical. A small number of people still get polio every year from the current polio vaccine, chicken pox from the chicken pox vaccine, etc. I suspect that it is for this reason this vaccine is being tested on HIV+ volunteers.

      For the same reason the regulatory hurdles for testing this vaccine on HIV- volunteers will be high, perhaps too high to overcome.

      Also, there have been tons of vaccines that caused a good immune response in phase 1 trials and ended up being ineffective, so let’s not be blinded by marketing press releases and not count our chicks before they hatch.

      Sep 6, 2013 at 11:42 am · @ReplyReply to this comment ·

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