HIV Vaccine: No Silver Bullet Yet

There is nothing I would like better than to wake up and learn of a new and effective HIV vaccine (except maybe a malaria vaccine), so I was excited to hear of a successful vaccine trial this morning. Multiple news agencies reported that a vaccine reduced the risk of HIV infection by 30%.

While the media loves a big story, these results were underwhelming. Although they were "statistically significant," it is way too early to declare success. A simple look at the numbers is more sobering: after vaccinating 16,000 people, there were 23 fewer new infections in patients receiving the vaccine (51 cases versus 74 cases). If one additional patient who received the vaccine became infected (52 instead of 51) the results would no longer be "statistically significant."

A misunderstanding of statistics and study design often leads to premature optimism as well as fear, when new studies come out. Today we learned that combining multiple injections of two vaccines that proved unsuccessful in the past may reduce the chance of new infections. I remain hopeful but VERY skeptical, given the modest differences and lack of biological evidence (there was no difference in viral loads between vaccinated and non-vaccinated patients who acquired HIV). While I am encouraged by the efforts and work being done to develop a vaccine, we have yet to find a silver bullet.

Meanwhile, condoms, education and empowering women remain the most effective ways to reduce infection. Improving access to treatment and to providing prophylactic medicines for pregnant HIV infected women are also incredibly successful and cost effective.

We currently spend a lot of money on abstinence education programs, which have proven unsuccessful and often highlight the failures of condoms. Encouraging abstinence and faithfulness are noble goals, but they should not divert money from strategies with a stronger track record of success. While we continue to wait for more promising results of vaccine trials, we should not wait to deliver more condoms, sex education, clean needles and drugs to reduce perinatal transmission of HIV.

Follow Dr. Peter Klatsky on Twitter: www.twitter.com/PeterKlatsky

Comments

[JuniperSunshine]

I already have been vaccinated. I'm married and we're both monogamous. While I applaud the development of new vaccines, and certainly new treatments for those suffering from AIDS, we still need to properly educate people as to what are high risk behaviors. As a young person, I learned that "anyone can get AIDS" - while technically true, my teachers were always careful not to dwell on the fact that abstinence and then monogamy are MUCH safer than "unconventional" intercourse with a condom with various partners. ***I was literally told that the riskiest behaviors were "low-risk" if a condom was used.*** Teens today think that they are just as likely to get AIDS from heavy petting as from "other" types of intercourse. Hey, no one calls it judgmental when you instruct people to wash their hands frequently during flu season and to avoid other high-risk behaviors, like smoking. I think that people can learn how best to avoid AIDS while still being taught compassion for its victims. Hey, it works for lung cancer.

[midia]

The epidemic of HIV/AIDS is horrific and it will be great if a cure can be found.
Abstinence is, of course, the one proven method of preventing the spread of AIDS. However abstinence training for adults is not mandated. Why? Have any social/educational groups involved themselves with teaching adults to abstain from having sex, to share needles, to stop practicing those things that spread this awful disease? A human spirit would be clean and free from the guilt of potentially spreading this disease to their multiple partners. They would be morally upstanding and noble.

[aliveoneinkiwiland]

nano true silver, tested on humans already and results shown that Nano sized TRUE silver attaches to HIV receptors, and blocks the virus from attaching to the host cells.
Look it up, Big Pharmas not interested, in an unpatentable HIV preventative, only in a vaccine will they reap the rewards in the billions.
Ironic, considering vaccine scientists who were involved in the African WHO small pox and USA Hep B for Homosexuals, vaccination drives in the late 70s say undeniably that because they used Monkeys to grow the viruses HIV was inherited from the Simians, just like SV40 (now public record) lead to Brain Tumours in humans.
Currently manufactures are using African Monkeys to grow H1N1 virus, while others use eggs. You got till oct 15 to decide whether to get your shot and your RFID bracelet or get carried off to the pound to have it done.
http://www.naturalnews.com/027093_RFID_vaccination_swine_flu.html
Army Whistleblower training for forced vaccinations and roadblocking 15 Oct. http://www.youtube.com/watch?v=rvALDJu9yDU&feature=player_embedded

[medicare4all]

"Meanwhile, condoms, education and empowering women remain the most effective ways to reduce infection. Improving access to treatment and to providing prophylactic medicines for pregnant HIV infected women are also incredibly successful and cost effective".

This needed to be said. Thank you, Dr. Klatzky.

[colinhockings]

How did you calculate that 74 vs 52 would no longer be statistically significant? As far as I can tell the study hasn't been published yet

[GrahamInCanada]

Statistically significant means that the results differ by a margin that is larger than the margin of error in the sample size.

Out of a sample size of 16,000, you would expect a margin of error of plus or minus twenty-two is what Dr. Klastsky was saying.

Therefore, if the results were 74 in one sample and 52 in the other, it would be within the margin of error and so it would be insignificant.

[synergie]

Ever heard of peer review? And they have been releasing some basics of the study involved. It's not that difficult of a calculation, pick up an epi text and run them through yourself. p values can be effected pretty easily, and with incidence numbers that are that low in comparison to the population being studied, it's more likely to show some skew. Also every physician that has mentioned this in the media along with the researchers involved has hailed this as a FIRST step, not as a success, but that we finally have a toe in the door in figuring out how to vaccinate against HIV. Which is pretty newsworthy, if not as easily understandable, as "HIV Vaccine works!".

[Exor Dium]

Why doesn't someone take a look at HCV (hep 'c' ). It is my understanding that there is approximately 12,000,000 people walking around America, not even knowing that they have it. These people, for the most part, are sexually active.
There is a cure for HCV but it takes 42 weeks of Pegalated Interferon Alpha 2-b chemo-thearpy which is very debilitating.
It's basically the same medicine that is used to treat Leukemia. I helped take care of a friend while he was undergoing this treatment.
I would hate to have to go through this chemo. It just about killed my friend. He begged me to shoot him between the eyes while he was sick. He's doing pretty good now. The Dr.'s can't detect any virus now.

Someone needs to do something !

If something isn't done soon, we'll be in the same shape with HCV as we are with HIV !

[synergie]

People are looking at Hep C, but the key here is prevention of infection. If all those hep C infected people were taught something other than "abstinence" and "condoms fail", then they wouldn't be catching or spreading it around. Basic education in personal hygiene and sexual hygiene is what is called for. People need to take some personal responsibility and take precautions to protect themselves, since it's not just people who "look" sick that can transmit diseases to them.

HCV and HIV are not at all on the same level. But education and personal responsibility are both the major factors in controlling further spread of the disease.

[PlaceboStudman]

Maybe I'm too overly cynical, but the way I see it, if even 10 people were helped by this trial, then it is reason to continue trials on newer, better derivatives of this particular treatment. Medical miracles do not happen overnight, but they do happen, and any progress toward the goal should be welcome and encouragement for further research using this research as its basis.

The astrophysicist Neil Degrasse Tyson said in an interview once that any and all conclusions, even the negative ones should be published, so that other researchers can build on your conclusions, and avoid making critical errors that may have led to a negative outcome THIS time. Because, in science, there really is always a next time, because even as one disease is cured, another may take its place and while the details of the research may differ, the scientific method does not

[karinova]

I'm with you!
The results were admittedly tiny-- barely even significant. But they were significant nonetheless.
Any positive result is better than zero (or yikes, negative) results. Therefore, this trial, by definition, WAS a success. The very first! Not "the" success, but "a" success. Seems to me that the thing they need to do is run out and do another trial just like this one, on this very same combination. If it's a fluke, it's a fluke. But if they get even just that same tiny positive result a second time? Then we are ON to something, baby!

Also? In the articles I read, the researchers were very clear about how modest the results were. If I were going to harsh on anything in this scenario, it'd be the lay media's parsing of it-- as usual. I guess Dr. Klatsky's doing his part to counteract them, which is good. But... you know what? This little glimmer of hope made me smile this morning. Can't we celebrate it for just one day?! Especially since I know I'll go back to wanting to resign from the human race tomorrow?

[PlaceboStudman]

You're not alone. I've wanted to resign from the human race since I was 15 LOL

But, seriously, you're right. Any result is significant. Frankly, I don't care about "statistical significance", because statistics only apply in a lab. The key is to have larger and larger sample sizes, because while anecodotal evidence may not be scientifically significant, 1,000 anecdotes BECOMES statistical significance, and the more work is done, the more studies and experiments are done on humans (animal testing does not always translate to human testing), the better the results will inevitably be

[Kenny Buchholz]

I Don't understand how a 0.3% statistic can become a 30% statistic.

Rougly - The infection rate in the Vaccine Trial was about 0.6%, while the infection rate in the placebo trial was about 0.9%, a difference of 0.3%. The DELTA was admittedly 30%, but this strikes me as an incredibly dishonest presentation of the facts.

[Dr. Peter Klatsky - Huffpost Blogger]

Good point, which is why we need to be cautious about interpreting "relative risk" reductions vs. "Absolute risk" reductions. Fortunately, actual infections do not occur in over 30% of all people. That said, if the vaccine truly reduces the number of new infections by 30%, that would be welcome news, I am still unsure that it will, when more data are available.

[Exor Dium]

Hey Dr. Klatsky !

Please do something about HCV.
My friend was needle pricked while working in a mental hospital and had to under go chemo. It just about killed him but his viral load subsided.
I understand that there are 12,000,000 people infected and don't even know it !
I understand that you are a different Dr. but you know more Dr.'s that do this type of administering.
If something isn't done soon, we'll be in the same place with HCV that we are with HIV !
I'm a Psych and I have to speak with a lot of people who are infected. They need help that I can't give them.