By Steve Weinstein-
At the beginning of the AIDS epidemic, people were looking for a way to prevent the disease. Almost as soon as HIV, the virus that causes AIDS, was discovered, specialists were speculating about a serum similar to the one Jonas Salk developed, which effectively put an end to the previous most serious health epidemic, polio.
Significantly, Salk himself actively looked for such a vaccine in the mid-’80s. But, as he and hundreds of other researchers have since confirmed, the so-called "magic bullet" that can be applied to entire populations has proved as elusive as the ever-evolving HIV molecule itself. Meanwhile, as we all know only too well, the virus continues on its grim journey, infecting hundreds of thousands of people and especially devastating the gay community.
A little over a year ago, a study in Thailand provided a ray of hope. But the results have been controversial -- not least because the tested group was the general population, which means that the rate of infection would be very low with or without the virus.
Partly for that reason, a study now under way in several U.S. cities is limiting itself to sexually active gay men. This is because we still represent a community at high risk for possible HIV infection. That means the results can be noticeable between those participants who receive a vaccine and those who receive a placebo.
But this study also differs from previous HIV vaccine trials in other important ways. It is limited to men who are circumcised; and to those men who do not possess antibodies to a particular type of adenovirus (that is, the common cold virus), Ad5.
People who do not have these antibodies will be enrolled in the study to see if a DNA vaccine, combined with an Ad5 "booster," will heighten the body’s ability to build T-cills and lower virus load -- if, that is, the participant is exposed to the virus.
It is a small but important step toward an eventual vaccine. If the researchers can determine that this vaccine combination will help people fight HIV, it would lead to more research about how the immune system works. That, in turn, would lead to knowledge about how to design more effective vaccines.
Volunteers receive two different vaccines, given in four injections over a six-month period. Three of them are DNA-based and the fourth is an Ad5 shot.
If this all sounds pretty far from that magic bullet, you should realize that this represents the real way to make progress: incrementally, through slow, small but steady steps.
Six cities -- Dallas; Annandale, Va. (suburban Washington, D.C.); Denver; Houston, Orlando; Cleveland, Ohio; and an additional site in New York - have been added to 11 cities already screening potential participants.
The study is called HVTN 505. HVTN stands for the HIV Vaccine Trials Network, a Seattle-based organization that coordinates HIV vaccine trials around the world. HVTN connects researchers with those in the community and the media who can help bring volunteers to such trials.
Those who step up to the plate to volunteer are first given a blood test to determine whether they have antibodies to Ad5 or not. (Obviously, most people aren’t aware of this rather obscure fact.) The reason for limiting the study to circumcised men is because a previous study seemed to indicate that circumcision -- along with a pre-exposure to Ad5 -- might have made a statistical difference in infection rates.
Steven Wakefield, who works in community relations for HVTN, explains that no one is ever exposed from additional exposure to HIV from taking part in the study. That said, as in other vaccine trials, there’s a chance that those receiving the vaccine might test positive for HIV.
Ironically, that’s a good thing: It means your body is producing antibodies to HIV, since the simpler HIV tests that you routinely get at the doctor’s office or at testing sites don’t look for HIV in the blood but rather the antibodies that fight HIV. Anyone testing positive who has been in the study who is not would probably receive more complicated testing that actually discovers HIV; also, participants get a document explaining the false diagnosis.
As with other such trials, the clinicians who administer the study don’t know whether the participant is receiving the vaccine or a placebo. People enrolled in the study who contract HIV -- that is, seroconvert -- during the study will be enrolled in a follow-up study to determine whether the vaccine has slowed the progress of HIV in their bodies.
This study marks perhaps the first time that transwomen have been specifically included with gay men. "That really was a challenge at some of the research sites," Wakefield explains. "We had to change the way the test is run, counseling. Even the receptionist had to be educated, so if a participant asked where to go to the bathroom, they’d go to the woman’s room" (even though biologically male).
What’s most important here is that you, the reader, consider enrolling. This writer enrolled in a vaccine trial several years ago, and I can testify that it in no way put my health at risk. In fact, it was reassuring to have my vital signs regularly monitored, to get tested for HIV every time I went into the clinic; to have a bit of safe-sex counseling (sometimes it’s nice just to talk about that with a disinterested third party); and to receive some money each time.
But most of all, it made me feel that, in however a small way, I was helping to lead to an eventual vaccine. HVTN is counting on the fellow-feeling of American gay men, who have been so affected by this epidemic. Since this trial is so limited as to who can participate -- circumcised gay men and transgender women with no antibodies to Ad5 -- it is all the more important to get a large number of you into the testing clinics.
If you are interested in seeing whether you qualify for this study and whether you live in a city conducting a trial, go to www.StandUp4Love.org.
-end-
Significantly, Salk himself actively looked for such a vaccine in the mid-’80s. But, as he and hundreds of other researchers have since confirmed, the so-called "magic bullet" that can be applied to entire populations has proved as elusive as the ever-evolving HIV molecule itself. Meanwhile, as we all know only too well, the virus continues on its grim journey, infecting hundreds of thousands of people and especially devastating the gay community.
A little over a year ago, a study in Thailand provided a ray of hope. But the results have been controversial -- not least because the tested group was the general population, which means that the rate of infection would be very low with or without the virus.
Partly for that reason, a study now under way in several U.S. cities is limiting itself to sexually active gay men. This is because we still represent a community at high risk for possible HIV infection. That means the results can be noticeable between those participants who receive a vaccine and those who receive a placebo.
But this study also differs from previous HIV vaccine trials in other important ways. It is limited to men who are circumcised; and to those men who do not possess antibodies to a particular type of adenovirus (that is, the common cold virus), Ad5.
People who do not have these antibodies will be enrolled in the study to see if a DNA vaccine, combined with an Ad5 "booster," will heighten the body’s ability to build T-cills and lower virus load -- if, that is, the participant is exposed to the virus.
It is a small but important step toward an eventual vaccine. If the researchers can determine that this vaccine combination will help people fight HIV, it would lead to more research about how the immune system works. That, in turn, would lead to knowledge about how to design more effective vaccines.
Volunteers receive two different vaccines, given in four injections over a six-month period. Three of them are DNA-based and the fourth is an Ad5 shot.
If this all sounds pretty far from that magic bullet, you should realize that this represents the real way to make progress: incrementally, through slow, small but steady steps.
Six cities -- Dallas; Annandale, Va. (suburban Washington, D.C.); Denver; Houston, Orlando; Cleveland, Ohio; and an additional site in New York - have been added to 11 cities already screening potential participants.
The study is called HVTN 505. HVTN stands for the HIV Vaccine Trials Network, a Seattle-based organization that coordinates HIV vaccine trials around the world. HVTN connects researchers with those in the community and the media who can help bring volunteers to such trials.
Those who step up to the plate to volunteer are first given a blood test to determine whether they have antibodies to Ad5 or not. (Obviously, most people aren’t aware of this rather obscure fact.) The reason for limiting the study to circumcised men is because a previous study seemed to indicate that circumcision -- along with a pre-exposure to Ad5 -- might have made a statistical difference in infection rates.
Steven Wakefield, who works in community relations for HVTN, explains that no one is ever exposed from additional exposure to HIV from taking part in the study. That said, as in other vaccine trials, there’s a chance that those receiving the vaccine might test positive for HIV.
Ironically, that’s a good thing: It means your body is producing antibodies to HIV, since the simpler HIV tests that you routinely get at the doctor’s office or at testing sites don’t look for HIV in the blood but rather the antibodies that fight HIV. Anyone testing positive who has been in the study who is not would probably receive more complicated testing that actually discovers HIV; also, participants get a document explaining the false diagnosis.
As with other such trials, the clinicians who administer the study don’t know whether the participant is receiving the vaccine or a placebo. People enrolled in the study who contract HIV -- that is, seroconvert -- during the study will be enrolled in a follow-up study to determine whether the vaccine has slowed the progress of HIV in their bodies.
This study marks perhaps the first time that transwomen have been specifically included with gay men. "That really was a challenge at some of the research sites," Wakefield explains. "We had to change the way the test is run, counseling. Even the receptionist had to be educated, so if a participant asked where to go to the bathroom, they’d go to the woman’s room" (even though biologically male).
What’s most important here is that you, the reader, consider enrolling. This writer enrolled in a vaccine trial several years ago, and I can testify that it in no way put my health at risk. In fact, it was reassuring to have my vital signs regularly monitored, to get tested for HIV every time I went into the clinic; to have a bit of safe-sex counseling (sometimes it’s nice just to talk about that with a disinterested third party); and to receive some money each time.
But most of all, it made me feel that, in however a small way, I was helping to lead to an eventual vaccine. HVTN is counting on the fellow-feeling of American gay men, who have been so affected by this epidemic. Since this trial is so limited as to who can participate -- circumcised gay men and transgender women with no antibodies to Ad5 -- it is all the more important to get a large number of you into the testing clinics.
If you are interested in seeing whether you qualify for this study and whether you live in a city conducting a trial, go to www.StandUp4Love.org.
-end-
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