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Boston HIV Vaccine Trial Looks For A Few Good Men -- And Women

by Francisco L. White
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Sunday Aug 5, 2012
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As the latest effort in their ongoing mission to prevent the spread of HIV, Boston’s Brigham and Women’s Hospital (BWH) is now recruiting HIV-negative transgender women, women and men who have sex with men (MSM) into their paid, clinical HIV vaccine trials.

"There is no possibility of contracting HIV from these vaccine studies," said Nakia Weaver, community education coordinator for the HIV Vaccine Clinical Trials in the Division of Infectious Disease at BWH. "The risks from the vaccine in our studies are the same risks that would come about from any vaccine: soreness at the site of injection and dizziness."

BWH emphasized that there is neither live nor killed HIV in the vaccines, but that they are created from a man-made protein that has receptor cells that resemble HIV. This study is "double blind," so neither the participant nor the clinician is aware of who is receiving the placebo or who is receiving the vaccine.

BWH has has great success in other vaccine trials, recently discovering a vaccine for the deadly virus Pseudomonas aeruginosa, which can lead to fatal, ventilator-associated pneumonia and cause lung infections in those with cystic fibrosis.

Since 1999, there have been more than eight thousand individuals diagnosed with HIV in Boston alone. The hospital has long been at the forefront of prevention efforts, as manifested in their recent launching of both high- and low-risk HIV vaccine studies, at two local sites: BWH and Fenway Health.

This year, BWH is working closely with local HIV prevention organizations, colleges/universities and local sex-positive institutions to present educational discussions on how to fight stigma and increase HIV prevention efforts. They are also inviting individuals with whom they interface to join these clinical trials, searching for a vaccine that could prevent HIV infection. Massachusetts Institute of Technology student and vaccine trial participant Sam, seen in the YouTube video below, is one example of their partner outreach program at work.

This type of coalition building is second nature to Weaver, who has always had a passion for helping and educating the community to overcome major public health issues. Her unit of educators, researchers and scientists is supported by the Division of AIDS (DAIDS), a branch of the National Institute of Allergy and Infectious Disease (NIAID), and has been in existence for 12 years.

With their help, BWH is currently enrolling participants into two low-risk studies: HVTN 094, which is specifically for men at "low risk" for HIV (low number of partners, no IV drug use) and who are not circumcised; and HVTN 085 for both men and women who are at "low risk" for HIV.

Recruitment is also being done for the high-risk HVTN 505 study, searching for MSM and transgender women who have sex with men, who are at a "high risk" for HIV (high number of partners, a pattern of unprotected sex and IV drug use). Weaver explained that they plan to recruit 12 participants into the HVTN 094 study, 11 participants into the HVTN 085 study and 40 participants into the HVTN 505 study.

The eligibility criteria for all studies is HIV-negative men and women between the ages of 18-50, who are able to come in for 12-14 study visits over the course of one year. Participants will undergo between two and four vaccine visits, during which they will receive a small injection in the arm. The remainder of the visits are follow-ups that include the recording of the participant’s height and weight, as well as a blood draw. Compensation is $50 for each completed study visit.

To see if you are eligible to join the BWH HIV clinical vaccine trials, visit www.brighamandwomens.org/research/labs/HIV_vaccine/default.aspx, email vaccines@partners.org or call 617-525-9219.


"Transgender individuals have been under-represented in clinical research and I hope that we’re able to correct that going forward," said Nakia Weaver.

HIV Prevention Efforts Via Vaccine, Circumcision and Truvada

There has been understandable excitement about the FDA’s recent approval of Truvada as an aid in HIV prevention. But the advancements being made at BWH, specifically those of the HIV Clinical Trials Unit, differ from what’s happening with Gilead Sciences (the makers of Truvada).

"Vaccines have historically been the best tool in our arsenal for preventing disease. Pre-exposure prophylaxis with drugs like Truvada is becoming part of an integrated HIV prevention strategy that includes HIV testing, treatment of infected sexual partners and male circumcision," said Weaver. "A safe and effective vaccine will be an important part of a combined HIV prevention strategy."

Although recent advancements have renewed optimism amongst affected communities about the possibility of discovering a vaccine in the near future, Weaver is cautious and realistic about the trial and error process inherent in these clinical trials.

"It’s quite difficult at present to know which of our current vaccine candidates will be successful at preventing HIV infection. But every trial we do gets us another step in the right direction," said Weaver.

BWH Education Programs Work to Combat HIV Stigma

BWH has also introduced two educational outreach campaigns in the Boston area: Red Ribbon Heroes and My "T" Matters. Both help to decrease the stigma associated with HIV, which Weaver noted, "is a major barrier to people getting tested, showing an interest in education and openly discussing the subject."

"BWH HIV Vaccine Clinical Trials Unit works with multiple organizations to combat the stigma associated with HIV," said Weaver. "We have also reached out to partner with local colleges and universities in the Greater Boston Area. Our educational sessions and outreach strategies are designed to cater to a variety of audiences."

Weaver said that the organization works with Be The Generation Bridge Partners: the Latin American Health Institute, the Multicultural AIDS Coalition of Boston, the Hispanic Black Gay Coalition, AIDS Action Committee, TransCEND, The Fenway Institute and the Boys and Girls Club of Boston.

Red Ribbon Heroes is an outreach and education campaign to raise awareness about HIV vaccine research, and it has been well received by the community. My "T" Matters, on the other hand, primarily targets the transgender community.

"Transgender individuals have been under-represented in clinical research and I hope that we’re able to correct that going forward," said Weaver, who has realized for years that some transgender individuals are at higher risk for HIV infection.

While outreach events have taken place in Central Mass. and the North Shore, Weaver agreed that more could be done and acknowledged that The Red Ribbon Heroes program was open to teaming with additional groups to organize outreach initiatives outside of the Greater Boston area. Weaver invited any groups interested in partnering with BWH to contact her.

For more information about these campaigns, visit www.facebook.com/redribbonheroes and www.facebook.com/mytmatters.

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