New AIDS Vaccine Comes in a Capsule

News on January 14th, 2015 Comments Off

Wanted: Volunteers to test an experimental new AIDS vaccine that is needle-free. The catch? You have to be willing to stay locked up in your room for 12 days.

The new vaccine comes in a capsule and it’s made using a common cold virus called an adenovirus, genetically engineered with a tiny piece of the AIDS virus.

It’s only a very early stage experiment, meant to show the vaccine is safe. However, if it is, it could be a start not only towards a much-needed vaccine against the AIDS virus, but needle-free vaccines against many different infections.

Researchers at the University of Rochester Medical Center are testing it in their specially designed facility usually used to test live influenza vaccines. The trial, which started Tuesday, is being paid for by the Bill & Melinda Gates Foundation.

“We’ve had success doing this before. The facility is very nice,” says Dr. John Treanor, a vaccine expert at Rochester who’s helping lead the study.

“We try and make sure they eat well and they are entertained. But they do have to stay in there for the 12 days.”

The reason is that the adenovirus used to make the vaccine is “alive” – it can replicate and presumably will spread in the digestive tract. Tests in monkeys show it should be safe, but the researchers are taking extra care because this particular strain, called adenovirus 26, only lives well in humans.

It’s been severely weakened, but so-called live vaccines tend to prompt a stronger immune response than “killed” vaccines.

“We have a strong suspicion that it is going to be safe. It is an attenuated virus,” said Dr. Dan Barouch of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, who helped design the vaccine. A similar oral vaccine has been given to hundreds of thousands of young military recruits to protect them against two other common old viruses – adenovirus 4 and 7 – that can cause severe outbreaks on bases.

And scientists hope that using the oral route will activate the immune system via the digestive tract – something that’s worked well before with, for instance, polio virus.

Making an AIDS vaccine has been one of the hardest problems facing medical science. The human immunodeficiency virus (HIV) that causes AIDS has infected nearly 78 million people. About 39 million have died, according to the World Health Organization.

In the United States, more than 1.2 million people have HIV, and about 50,000 people are newly infected each year. Medications can keep infected people healthy, but there is no cure. Some of the same drugs can also protect people against infection but they must be taken daily, unlike a vaccine.

Doctors have been working to make a vaccine against HIV for decades, but while they’ve had partial successes, nothing has worked as well as vaccines against measles or smallpox.

It’s partly because HIV attacks the very immune cells that are usually mobilized by a vaccine, and partly because the virus cloaks itself in an ever-changing envelope.

The new vaccine was designed using a computer program that’s picked out a batch of these envelope protein disguises from HIV around the world. The hope is that it will help the immune system recognize and respond to a range of disguised HIV proteins.

As the harmless adenovirus spreads, it should activate an immune response. The immune system cells will also “see” the attached bit of HIV and, the researchers hope, react against any HIV virus should the vaccinated person ever be exposed.

Other vaccines have been made against HIV using killed adenovirus. They haven’t worked too well. Barouch hopes that using a live one will work better.

Another reason vaccines made using adenoviruses have not always worked well is because the viruses are so common. People already often have an immune response to them, so the vaccines don’t have time to take hold in the body.

Adenovirus 26, however, is very rare, Treanor says. “It’s an unusual serotype of human adenovirus,” he told NBC News. It has only infected about 5 percent of the population, he said, and doesn’t make people sick. “It does not appear to be associated with any detectable symptoms,” he said.

That suggests the vaccine, if it protects against HIV, could be widely deployed.

And if the capsule form works, so much the better. “On a practical basis, an oral vaccine would be highly desirable, particularly in the developing world,” Treanor said.

And Barouch says there’s no reason a similar vaccine design couldn’t be used to make immunizations-in-a-pill against a range of bacteria and viruses.

UR Tests HIV Vaccine Pill

News on January 14th, 2015 Comments Off

Researchers at the University of Rochester Medical Center are testing a new oral vaccine to prevent infection with HIV, the virus that causes AIDS. The vaccine is unique because it is given as a pill, unlike most HIV vaccines tested to date that have been given as shots.

The study is funded and designed by Beth Israel Deaconess Medical Center (BIDMC), which received support for a Collaboration for AIDS Vaccine Discovery grant from the Bill & Melinda Gates Foundation. The URMC team and BIDMC are collaborating with the International AIDS Vaccine Initiative, which is helping to organize the study through its Vaccine Product Development Center to provide services to BIDMC grantees.  This is one of the first studies to benefit from this partnership and URMC is the only center in the world testing this vaccine.

The vaccine is made of a live virus called adenovirus, a common cause of respiratory and gastroenteritis infections. The particular type of virus proposed in this study rarely causes any symptoms in adults and has been weakened to further reduce the risk of people getting sick.  It contains a protein that prompts the body to make an immune response against HIV. The study vaccine is not made from actual HIV.

Michael C. Keefer, M.D.

Researchers hope that this oral vaccine will create a more robust immune response against HIV. “We think that an oral approach may be the way to create a more effective vaccine and I’m sure that most people would rather get a vaccine in a pill rather than by yet another shot,” said Michael C. Keefer, M.D., professor of Medicine and director of the University’s NIH-supported HIV Vaccine Trials Unit.

John J. Treanor, M.D., professor of Medicine and chief of Infectious Diseases at UR Medicine’s Strong Memorial Hospital is leading the study with support from Keefer, who has more than 20 years of experience in the preventive HIV vaccine field. They will monitor how people’s immune systems respond to the vaccine and if the vaccine causes any symptoms.

The University has a long track record of conducting detailed studies of HIV vaccines, but Keefer says that this is the first time an oral vaccine has been tested in Rochester. Though the research is in its early stages, he believes the information collected from this study may help develop a vaccine that could one day become the standard of care.

John J. Treanor, M.D.

Participants must be between the ages of 18 and 40, in good health and not infected with HIV. Participants will be required to spend 12 days and 11 nights at the study center and will be paid up to $2,050 based on their level of participation. To see if you qualify for a study screening, which involves a mini-physical, health questionnaire and blood work, call 585 756-2329.

For Media Inquiries:
Emily Boynton
(585) 273-1757
Email Emily Boynton

Source story published here:

National Gay Men’s HIV/AIDS Awareness Day: Sept. 27, 2014

News on September 23rd, 2014 Comments Off

63% of new HIV infections in the United States
occur among gay and bi men.

1 in 5 gay men in major US cities is living with HIV.
Nearly half don’t know it.


Join the Rochester Victory Alliance for a special awareness night at Tilt Nightclub.

  • Free T-shirts thrown to the crowd
  • Free glow sticks
  • Information tables from local community agencies, including the Rochester Victory Alliance

TILT logo webTilt Nightclub
444 Central Avenue
Rochester, NY 14605

Saturday, September 27, 2014
Doors open: 10:00pm

Modern Era HIV Prevention: Pre-Exposure HIV Prophylaxis (PrEP) and HIV Vaccine

News on May 22nd, 2014 Comments Off

CME/CNE Provided
Thursday June 12, 6:00PM-7:30 PM
Trillium Health
259 Monroe Ave – between S Union & Alexander – parking behind building

Welcome, CME/CNE process, declarations, Trillium PrEP Initiative
● William Valenti MD

PrEP Background/ Science
● Roberto Corales DO

Adverse events/ Adherence strategies/ Cost
● Ashley Zuppelli Pharm D

Behavioral Issues
● Shaw Ree Chen PhD

HIV Vaccine Update
● Michael Keefer MD

● Moderator: William Pellett

Describe/understand the…
● The impact of pre-exposure prophylaxis and vaccine as HIV prevention tools.
● New CDC and NYS Department of Health guidelines for PrEP use.
● Barriers and approaches to implementation of PrEP in real-world practices.
● Current status of HIV vaccine development.


Healthcare professionals: Click here to register!

Bill Valenti: or 585.733.3961
Tom DellaPorta: or 585.275.7655


An Evening of Diversity and Empowerment

News on February 26th, 2014 Comments Off

Sheryl Lee Ralph

National Week of Prayer for the Healing of AIDS 2014

News on February 10th, 2014 Comments Off

UR given $1M grant for HIV treatment, prevention

News on December 10th, 2013 Comments Off

The University of Rochester has received more than a $1 million grant from the Department of Health and Human ServicesNational Institute of Allergy and Infectious Diseases for research on the treatment and prevention of HIV.

U.S. Senators Charles Schumer and Kirsten Gillibrand announced the $1,030,764 grant will fund efforts to develop better treatment methods and standards of care for people living with HIV. That effort includes clinical trials for a preventive HIV vaccine at the University of Rochester Clinical Trials Unit.

The new award from the National Institutes of Health is a renewal of a research program that UR’s Infectious Diseases Division has had since 1987, and will fund UR HIV/AIDS clinical trials through 2018.

"The funding will advance the University of Rochester’s groundbreaking research in HIV treatment and prevention, keep our nation’s top scientists flocking to the Rochester area, and most importantly, it may lead to the development of an HIV vaccine," Schumer said in a statement.

It funds the UR HIV/AIDS Clinical Trials Unit and includes research on new treatment options for HIV-positive patients, as well as research studies focused on developing an effective preventive HIV vaccine for those who are not infected with HIV.

"When we invest in new research for HIV, we can unlock discoveries for new treatments and help save more lives, attract even more bright minds to Rochester, and support new economic growth," Gillibrand said.

The grant, headed by Dr. Michael C. Keefer, director of the HIV/AIDS Clinical Trials Unit, comes on the heels of the UR’s new designation as a Center for AIDS Research (CFAR). Only institutions with a certain level of existing HIV/AIDS grant funding are able to compete for a CFAR designation, and UR is now one of 19 CFARs across the country.

"The renewal of our treatment and vaccine research program and our new CFAR designation puts the University of Rochester amongst an elite group of institutions conducting AIDS research in this country," Keefer said. "We are very excited to be able to continue our work to improve the quality of life of those living with HIV and ultimately find a vaccine that will prevent the spread of HIV around the world."

To view the source article, visit:

URMC to Host Local AIDS Memorial Quilt Panels

News on November 27th, 2013 Comments Off

For more information, visit: Poster

To our RVA Friends and Western NY Community

News on April 25th, 2013 Comments Off

We have some important new information from the HVTN 505 vaccine study to share with you.

We are going to stop further injections in the HVTN 505 study because the vaccine did not show efficacy. This means it did not work to prevent HIV infection nor reduce the amount of virus (viral load) in the blood among people in the study who became infected with HIV. Participants enrolled in the study will be unblinded (find out whether they received a vaccine or placebo) in the upcoming few weeks, but study visits will continue.

The first order of business when we heard this news was to notify our study participants (prior to the release of the information to the public). At this time, all RVA HVTN 505 volunteers enrolled in Rochester and Buffalo have been contacted/informed of this important study update.

Although the news is not what we were hoping for, the ongoing support of our volunteers and our community will continue to allow us to better understand how to develop effective HIV vaccines. This news is extremely disappointing to our team, but the information we gain from this study is critical in planning the future direction of HIV vaccine research and we could not have learned this without your support.

Undoubtedly, there will be a lot of news about this study in the upcoming days and weeks. We are committed to providing accurate information to our volunteers and community partners at the earliest possible time. At this time we can provide you the press release sent out today by the National Institute of Health.

As additional information is released we will share this with you. If you have questions or comments about this study or HIV prevention in general, please don’t hesitate to contact us!

Thank you once again for your commitment to ending AIDS!

The entire Rochester Victory Alliance team

Daily HIV Prevention Approaches Didn’t Work for African Women in the VOICE Study

News on April 11th, 2013 Comments Off

Original article accessed 4/11/13, Microbicide Trials Network:

Truvada found not an effective strategy in this population
Young, single women were least likely to use tablets or gel, and more likely to get infected at very high rates

ATLANTA, March 4, 2013 – Results of a major HIV prevention trial suggest that daily use of a product – whether a vaginal gel or an oral tablet – does not appear to be the right approach for preventing HIV in young, unmarried African women.
Of the three products tested in the VOICE Study – tenofovir gel, oral tenofovir and oral Truvada® – none proved to be effective among the 5,029 women enrolled in the trial; most participants did not use them daily as recommended. Drug was detected in less than a third of blood samples from women who were assigned to use either Truvada or oral tenofovir and in less than a quarter of samples from women designated to use gel. Moreover, those least likely to use their assigned products, single women under age 25, were also the most likely to acquire HIV. Incidence in these young women approached nearly 10 percent in some of the study sites in South Africa, a rate considerably higher than expected, according to study results presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
“Although there may be other explanations for why these products don’t always work to prevent HIV, it’s hard to ignore the fact that so few women in our study used them. Clearly, an approach of daily product use is not going to work for the population of women who participated in VOICE. Equally important, the women in our study—especially in South Africa—experienced rates of HIV acquisition that were much higher than we expected. The bottom line is that this group of young women remains at very high risk of HIV infection, and urgently needs safe, effective and practical HIV prevention methods that they will actually use,” said Jeanne Marrazzo, M.D., M.P.H., who reported the results on behalf of a team of investigators from 15 trial sites in Uganda, South Africa and Zimbabwe.
VOICE – Vaginal and Oral Interventions to Control the Epidemic – was conducted by the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) and led by Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Dr. Marrazzo, from the University of Washington in Seattle.
“No intervention is going to be effective if it’s not used, and the point is that the majority of women in VOICE didn’t use any of the study products as recommended. So, while we are disappointed in these results, we have answered the questions VOICE was designed to answer, and what we have learned is critically important.”
Dr. Chirenje added.
Although other studies in other populations have shown that with consistent use, both oral Truvada and oral tenofovir are highly effective for reducing the risk of HIV, the VOICE results confirm those of the FEM-PrEP study, which tested daily use of Truvada and involved a very similar population of women. As in VOICE, most FEM-PrEP participants didn’t follow the daily regimen.
VOICE, which began enrolling women in September 2009, was designed to evaluate whether antiretroviral (ARV) drugs commonly used in treating HIV are safe and effective in preventing sexual transmission of HIV in women as either a vaginal gel or an oral tablet used daily, an approach called oral pre-exposure prophylaxis, or PrEP. VOICE originally had five study groups. Participants were randomly assigned to use either tenofovir gel or a placebo gel (with no active ingredient), or one of three tablets: tenofovir (known by the brand name Viread®), Truvada (the brand name for a tablet containing both tenofovir and emtricitabine) or an oral placebo. Participants were asked to use their assigned products daily, and all received ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of sexually transmitted infections (STIs) – standard approaches for reducing the risk of HIV – throughout the trial.
In late 2011, VOICE stopped testing oral tenofovir and tenofovir gel after separate routine reviews of study data by an independent group of experts determined that while each was safe, neither was effective in preventing HIV compared to the matched placebos among the women in those groups. Because the study was ongoing and still blinded, study investigators did not know why these products were not effective. VOICE continued to evaluate Truvada until the scheduled end of the study in August 2012.
At CROI, Dr. Marrazzo reported that 312 of the 5,029 women enrolled in VOICE acquired HIV during the study, for an overall HIV incidence of 5.7 percent, nearly twice the rate that investigators had expected when they designed the trial. (Another 22 women were later identified to be infected at enrollment and excluded from the analysis, which was based on 5,007 participants.) HIV incidence, which reflects the number of women who become newly infected for every 100 participants in a given year, ranged from 0.8 percent in Zimbabwe, to 2.1 percent in Uganda, to 7 percent in South Africa. It was nearly 10 percent at some South African trial sites.
No safety concerns were identified for any of the products, yet the study found that, like oral tenofovir and tenofovir gel, daily use of Truvada was not an effective strategy, with 61 of 994 women in the Truvada group acquiring HIV (4.7 percent HIV incidence) compared to 60 of 1,008 in the oral placebo group (4.6 percent incidence).
Of the 1,002 women in the oral tenofovir group, 60 acquired HIV. HIV incidence, however, was calculated to reflect what had occurred up until Oct. 3, 2011, when sites began informing participants that testing of oral tenofovir was to stop. At this time, there were 52 infections in the tenofovir tablet group and 35 in the oral placebo group, for HIV incidence rates of 6.3 and 4.2 percent, respectively. Of the 1,003 women assigned to use tenofovir gel, 61 women acquired HIV (5.9 percent HIV incidence), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent HIV incidence). Though the estimates of effectiveness for both oral tenofovir and Truvada were less than zero, tenofovir gel was estimated to reduce the risk of HIV by 14.7 percent compared to the placebo gel, but with a confidence interval indicating the level of effectiveness could be between -21 percent and 40 percent, this finding was not statistically significant.
An analysis of blood samples from a subset of 773 participants (including 185 women who acquired HIV) found adherence to product use was low across all groups: drug was detected in 29 percent of blood samples from women in the Truvada group, 28 percent of samples in the oral tenofovir group and 23 percent among those in the tenofovir gel group. In sharp contrast, adherence to product use was calculated to be about 90 percent based on what the participants themselves had reported to trial staff and on monthly counts of unused gel applicators and leftover pills.
Perhaps most concerning to the researchers were the study’s findings highlighting the gravity of the epidemic in a population that continues to be among the most vulnerable: young, single women. HIV incidence was 8.8 percent for unmarried women younger than 25 compared to 0.8 percent for older women who were married, differences that were statistically significant. Moreover, young, single women were much less likely to use their assigned study product. In the Truvada group, for example, drug was detected in the blood of just 21 percent of younger, single women compared to 54 percent of those married and over age 25.
The team hopes to understand why women did or did not use the products, including how perception of HIV risk may have played a role. Analysis is ongoing of two qualitative behavioral studies, VOICE C and VOICE D, with results expected in the coming months. Examination of drug levels in vaginal fluid is also planned, which should provide greater insight into the relationship between product use and product efficacy, particularly for tenofovir gel.
Other results still to be reported include a secondary analysis that is hoped will provide information about the potential of tenofovir gel to reduce the risk of herpes simplex virus (HSV-2), and results of the Bone Density Sub-study (VOICE B). VOICE B is an observational study in a subset of VOICE participants designed to explore the effects of oral study products on bone health. Participants are being followed until August 2013, and results are expected before the end of the year.
“In VOICE, our primary aim was to determine the safety and effectiveness of vaginal and oral products used daily, but also to learn which approach the women in our study would prefer. They apparently wanted neither,” commented Sharon Hillier, Ph.D., of the University of Pittsburgh School of Medicine, who with Ian McGowan, M.D., Ph.D., is co-principal investigator of the MTN. “Products that are long-acting, such as the dapivirine vaginal ring, which we are evaluating in the ASPIRE study, and that women use for a month at a time, may be more suitable for this vulnerable population.”
Women account for 60 percent of adults with HIV in sub-Saharan Africa, where unprotected heterosexual intercourse is primarily to blame for the region’s heavy HIV burden. Young women are especially vulnerable. Efforts to promote abstinence, monogamy and male condom use haven’t been enough to stop the HIV epidemic nor are these methods feasible in most settings. There is an urgent need for effective strategies that women can control themselves and be willing to use.
Of the 5,029 women enrolled in VOICE, 4,077 were from South Africa, 322 from Uganda and 630 were from Zimbabwe. The mean age was 25.3 (nearly half were younger than 25); and 79 percent of the participants were single. In South Africa, the mean age was 24.7, although more than half (55 percent) were under age 25 and only 8 percent were married. In contrast, the mean age in Uganda and Zimbabwe, was 28.3 and 28.1, respectively; 50 percent of the women enrolled in Uganda were married, while in Zimbabwe, 94 percent were married.
VOICE was funded by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The study products were provided by Gilead Sciences, Inc., of Foster City, Calif., and by CONRAD, of Arlington, Va. Viread (oral tenofovir) and Truvada are registered trademarks of Gilead Sciences. In 2006, Gilead assigned a royalty-free license for tenofovir gel to CONRAD and the International Partnership for Microbicides of Silver Spring, Md.
# # #
Tenofovir and Truvada are both approved for the treatment of HIV when used in combination with other ARVs. In July 2012, the U.S. Food and Drug Administration approved the use of Truvada also for HIV prevention, a decision based largely on the results of two pivotal trials in two different populations – the iPrEx study in 2,500 men who have sex with men (MSM), and the Partners PrEP Study involving 4,758 heterosexual couples in which one of the partners has HIV. In iPrEx, there were 42 percent fewer HIV infections in the Truvada group compared to the placebo group. Partners PrEP, which tested both tenofovir and Truvada, found daily use of Truvada reduced HIV risk by 75 percent and 67 percent with tenofovir. TDF2, a smaller study in 1,200 heterosexual men and women also found Truvada effective, with a 62.6 percent reduction in HIV risk compared to placebo. These same studies also demonstrated that Truvada was more effective in protecting against HIV when the daily regimen was followed consistently. Indeed, Truvada was not effective in the FEM-PrEP Study, and many of its participants, 2,119 women from Kenya, South Africa and Tanzania, didn’t take the tablets.
In July 2012, the World Health Organization (WHO) issued guidance on PrEP for serodiscordant couples (in whom one partner is HIV-infected) and MSM, recommending its use only in the context of demonstration projects. WHO expects to issue formal PrEP implementation guidelines in 2015 that will consider emerging evidence from trials such as VOICE, as well as outcomes of in-country demonstration projects. Information about Truvada and its “real world” use is being collected in open-label trials, such as iPrEx OLE and the Partners Demonstration Project, and in several other demonstration projects and implementation studies taking place in the United States.
Tenofovir gel used before and after sex was found to reduce the risk of HIV by 39 percent in the CAPRISA 004 study, a finding that was considered a major milestone for the field. The study, which involved 889 women at two sites in the KwaZulu-Natal province of South Africa, unexpectedly found that tenofovir gel also reduced the risk of HSV-2 by 51 percent, the first time that any kind of biomedical prevention method was shown to be effective against HSV-2. FACTS 001, an ongoing Phase III trial of the same regimen used in CAPRISA 004 (before and after sex) that plans to enroll 2,900 women at nine South African sites, hopes to replicate the CAPRISA 004 findings, with results expected in 2015. Concurrently, former CAPRISA 004 participants are being invited to enroll in CAPRISA 008, an open-label follow-on study looking at the feasibility of gel delivery through family planning services.
In other MTN studies, researchers are evaluating a reduced glycerin formulation of tenofovir gel. In one trial to be conducted in South Africa and the United States, researchers will examine drug absorption patterns in both rectal and vaginal tissue when the gel is applied either vaginally or rectally, while a Phase II trial, MTN-017, hopes to determine whether the reformulated gel is safe and acceptable as a rectal microbicide among men who have sex with men (MSM) and transgender women in Peru, South Africa, Thailand and the United States. MTN-017, which is the first Phase II trial of a rectal microbicide, is expected to begin mid-2013.
More information about VOICE can be found at A summary of other oral PrEP and tenofovir gel studies can be found at
About the MTN
The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.