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AIDS and HIV

HIV research sped development of COVID vaccine

“It’s time to take what we’ve learned from coronavirus and take it back to HIV and build upon from what we have learned.”

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Carl W. Dieffenbach, Director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases (Official NIAID portrait)

ROCKVILLE, Md. – Since 1996, Carl W. Dieffenbach, who holds a Ph.D. in biophysics from John Hopkins University, has served as director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases, which is an arm of the U.S. National Institutes of Health or NIH.

In a June 10 interview with the Washington Blade, Dieffenbach gave an update on the extensive, ongoing research into the development of an HIV/AIDS vaccine that he has helped to coordinate for many years, including current human trials for a prospective AIDS vaccine taking place in the U.S., South America, and Africa.

One thing he feels passionate about is a development not widely reported in the media reports about the successful development of the COVID-19 vaccine. According to Dieffenbach, the extensive research into an AIDS vaccine in recent and past years, while not yet successful in yielding an effective AIDS vaccine, helped lay the groundwork for the rapid development of the different versions of a COVID vaccine.

“Because my division runs the largest clinical trials program in the word, we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that,” he said. “And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna – were first piloted by NIH and Moderna to try to make an HIV vaccine,” Dieffenbach says.

“So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines,” he told the Blade. “And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from what we have learned.”

Dieffenbach says one reason the development of a COVID vaccine came about before an AIDS vaccine, despite more than 20 years of AIDS vaccine research, is that the HIV virus is far more complex than the coronavirus, especially its ability to infect and remain embedded in the infected person for life. 

“Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144,” Dieffenbach says. “We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy,” he said, meaning it did not work.

“So that was a big disappointment to us,” he says “But in the meantime, we had pushed forward with the J&J [Johnson and Johnson pharmaceutical company] vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not,” he says. “We’re very close to an answer.”

Washington Blade: Where do things stand in the development of an HIV/AIDS vaccine in light of Dr. Fauci’s statement a few weeks ago that the development of a COVID-19 vaccine could provide a boost to developing an AIDS vaccine?

Carl Dieffenbach: Sure. So, maybe I can start by introducing myself to you as a way of putting this into a context.

So, I’m the director of the Division of AIDS, which is the largest funder of HIV research in the world. And I report directly to Dr. Fauci. So, I’m responsible for all AIDS, all the time. And that is my passion and purpose in life. Part of that is working toward a safe, effective, and durable HIV vaccine, which has been one of the two most challenging questions left in science today. The other is a cure. They are connected in some ways.

So, with that as background, when coronavirus disease came along – because my division runs the largest clinical trials program in the world – we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that. And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna were first piloted by NIH and Moderna to try to make an HIV vaccine. So, we’ve being working on that platform with Moderna for several years.

The leadership at Pfizer used to be part of a group at Penn, where we were also working with them. The J&J vaccine – we currently have in two Phase III clinical trials for HIV, one in sub-Saharan Africa, specifically in young women and the other one in the Americas in men who have sex with men and transgender individuals. Both of those Phase IIIs are moving along. The women’s study is fully enrolled. The men’s study was hit hard by COVID, but we worked through and will be fully enrolled by September.

One other vaccine just to talk about is the Oxford vaccine, the AstraZeneca vaccine. That is also using a platform at Oxford University, which has been used for HIV. So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines. And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from where we have learned.

Blade: That’s very interesting. But can we assume, then, from the clinical trials that have taken place for an HIV vaccine that they did not succeed in providing the immunity needed for an effective vaccine? 

Dieffenbach: So, that’s exactly the problem we have. Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144. We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy. So, that was a big disappointment to us. But in the meantime, we had pushed forward with the J&J vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not. We’re very close to an answer.

Blade: So, the human trials are ongoing.

Dieffenbach: Oh, again – the study in young women in sub-Sahara Africa is fully enrolled. The men’s study will be fully enrolled in September. So, we have fought through the coronavirus epidemic to maintain, to nurse these trials along to make sure with the $100 million or so we’ve invested, that we didn’t want them to go down the drain literally because we lost too many people for follow-up. So, this was a herculean effort that has gone on all the time trying to do the vaccine studies for coronavirus disease, which we were also incredibly successful in.

Blade: Can we assume all of the people participating in the studies were HIV negative?

Dieffenbach: Yes, they’re HIV negative. They are people who are at risk. And also, in South America, for example, the major countries we’re in are Peru and Brazil. And they’ve had a strong research culture with us, going back more than a decade. For example, both of those countries played big roles in our studies of pre-exposure prophylaxis. A study called I-PREX that demonstrated that in men who have sex with men that [a PrEP drug] works well to prevent HIV acquisition in seronegative men who have sex with men.

So, we’ve been there. This is a really good setup for the countries, for the citizens that are in those countries that want to avail themselves to the research that has benefited everybody.

 Blade: Among those who are participating in these ongoing AIDS vaccine trials, can we assume they cannot be taking the PrEP anti-retroviral drugs that have been shown to be highly effective in preventing HIV infection?

Dieffenbach: So, what we’ve done is we – everything is by conversation. So, when somebody who is interested in the study comes in, we talk to them. What is your chief interest in being in this study? And a lot of people want to be in the study because then they can access PrEP. They want to make it easier to get a hold of pre-exposure prophylaxis. They feel that is the best way that they can protect themselves.

So, in that situation, what we do is we take those people and link them to PrEP services where they can easily get PrEP in their community. So, first it’s taking care of those people. Then there are people who really have no interest in PrEP. And we actually counsel them every time they come in for a study. Are you sure you don’t want to access PrEP? And those are the people we then say, if you’re not interested in PrEP, what do you think about participating in a vaccine trial?

Because they’re the ones who have the most freedom of thought. They don’t have an opinion about the vaccine or about PrEP. So, those are the people we’ve been focusing on and enrolling. So, we’ve been very careful to make sure that if people wanted PrEP they not only have access, but they didn’t feel like somehow having to trade something in order to get it. The freedom to join a study should be a free choice. And it shouldn’t be a coercive thing to get PrEP. So, we just took that off the table and said if you’re truly interested in PrEP we can get you PrEP and make sure that was available. 

Blade: So, in that case, if they choose PrEP they would not be in the vaccine trial?

Dieffenbach: You know, it’s interesting that you ask it in that way. Because you have relationships with your community, many of the investigators have reported that people will say, you know I tried PrEP and it wasn’t for me. It made me gaseous. It upset my stomach. I wasn’t myself. I tried it. I couldn’t make it work for me. I want to stop PrEP. Am I still eligible for the [vaccine] study? And the answer is of course. Many people are very happy on PrEP and they come in for visits occasionally and say this is working for me and just have the relationship with the doctors there, so it works. So, again, it’s about maintaining contact with your communities.

Blade: Can you tell a little about what happens next after people become part of an HIV vaccine trial. Do you have to keep in touch with these people, and do they have to get an HIV test periodically?

Dieffenbach: Exactly. So, the vaccine consists of a series of injections. It’s a mixture of vector systems that delivers a series of encoded HIV genes that are specifically designed to induce very broad immunity. There’s a whole computer-based process to design those components of the vaccine to make sure that it has sequence similarities with all the different versions of HIV circulating in the globe. And then at the end there is a protein boost. And we carry this out.

So, about every three to four months people come in. They get a shot. They fill out questionnaires. They give a blood sample. And they’re tested for HIV and are given a boost or a placebo. And they stay in touch with the clinic. They come in and out of the clinic. And the retention is quite high in these situations because people really like having the attention of the clinic available to them. It’s part of the community.

Blade: So, they go to a clinic for all of this?

Dieffenbach: It’s a research clinic. It’s not like a state-run health clinic. It’s a research clinic. Clinic is just a term for where people are seen.

Blade: Are any of these AIDS vaccine trials that are going on taking place in the United States?

Dieffenbach: Yes. So, the study is called Mosaico. And it’s HVTN706. And we have sites throughout the United States as well as South America. But that study is limited to men who have sex with men – the one in the United States.

Blade: Is it broader than just men who have sex with men in other countries?

Dieffenbach: No, so we decided to really focus on specific at-risk populations. So, in the Americas we chose to focus on men who have sex with men and transgender individuals. And sub-Saharan Africa we focused on young women because that is the target of the study population. So, 705 is all women in sub-Saharan Africa. And in the Americas in North and South America it is all men who have sex with men and transgender individuals.

Blade: Can we assume that the researchers that are doing these studies have a sensitivity of LGBTQ people? Is there still an issue where people worry about being outed as being gay or transgender?

Dieffenbach: So, many of the sites that we work with have been part of our system for over 20 years. And so, they are trusted members of the LGBTQ community within their cities and states. And ‘states’ is a literal term where it’s a state in Colombia or Peru or Brazil. And so, it is part of the fabric of the gay community in these places. Just like in San Francisco the San Francisco health clinic and the DCF clinics are part and parcel of everything the community does there.

And so, the lead physician in San Francisco is Susan Buchbinder. She has been a leader in health in this population for over 25 years or actually closer to 30 years at this point. We’re all getting old. Do you know that? So, we have been at this a very long time. And really have tried to build structures that are durable and therefore are reliable to the community. And that’s where we go back to the same groups time after time.

Blade: Have the locations of the vaccine testing sites been released publicly?

Dieffenbach: Yes, all of that is publicly available on clinicaltrials.gov. If you go into clinicaltrials.gov and search HVTN705 or HVTN706 you will get a version of the protocol, all the times it’s been modified, where we are – the protocol. All of that is public knowledge and available to you. HVTN705 is the women’s study. HVTN706 is the men’s study.

Blade: Is there a timeframe for when these latest vaccine studies might be completed?

Dieffenbach: I think within the next several months. We will get an answer out of the women’s study and then the men’s study is probably a year away. We were slowed a little bit because of COVID. We actually had to pause enrollment for several months. But we’re back on track.

Blade: Isn’t there a parallel research effort for an HIV/AIDS cure?

Dieffenbach: Yes, we have a very large program in cure research. It is a lot earlier in the discovery process and so it’s still very ‘researchy.’ And we have a very large program called the Martin Delany Collaboratories for Cure Research. Martin Delany was an activist who really pushed NIH in so many wonderful ways to really take the need for a cure seriously. His argument was a cure is the next logical step after effective anti-retroviral therapy. You cannot stop with one pill once a day. You’ve got to keep going. And he was pretty persistent. And unfortunately, he died several years go and we just thought the best way to honor him, and his memory was to name a program after him.

Editor’s note: Next week, in the second and final installment of his interview with the Blade, Dr. Dieffenbach discusses the progress in research and studies into an HIV/AIDS cure and explains from a scientific standpoint why an HIV vaccine is taking longer to develop than a COVID vaccine.

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AIDS and HIV

Governor Newsom signs HIV & Aging Act authored by Sen. John Laird

Sponsors of SB 258 include Equality California, AIDS Project Los Angeles (APLA) Health, Services & Advocacy for GLBT Elders (SAGE)

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Photo Credit: Office of the Governor of California

SACRAMENTO – On Friday Governor Gavin Newsom announced the signing of Senate Bill 258, the HIV & Aging Act, authored by Senator John Laird (D – Santa Cruz). Senate Bill 258 will ensure HIV+ seniors are included in the definition of “greatest social need”.

“When I was the Santa Cruz AIDS Agency Director in the 1980’s, it was our dream to have people living with HIV live into old age,” said Senator Laird. “To be very clear, this group was not supposed to age. Governor Newsom signing the HIV & Aging Act is a historic moment for the LGBTQ community, and all those who have been affected by the HIV crisis.”

With the recent advancements in HIV treatment, people with HIV can keep the virus suppressed and live long and healthy lives. For this reason, the number of HIV positive older people is increasing. According to a 2018 California HIV Surveillance Report published by the California Department of Public Health, over half of the people living with the virus in California are now aged 50 years or older. This same report shows that 15 percent of newly diagnosed patients were age 50 and older in that same year.

Sponsors of SB 258 include Equality California, AIDS Project Los Angeles (APLA) Health, Services & Advocacy for GLBT Elders (SAGE), and the Los Angeles LGBT Center.

Sen. John Laird speaking at PRIDE with the LGBTQ Legislative Caucus June 2021 (Blade File Photo)

Equality California Legislative Director Tami A. Martin notes, “After surviving the darkest days of the AIDS epidemic, many Californians living with HIV are now over the age of 50, but in dire need of support. Thanks to Governor Newsom, Senator Laird and HIV advocates, the Golden State will now make sure that our elders living with HIV have access to food assistance, job training, transportation or any other vital services. We applaud Governor Gavin Newsom for signing the HIV & Aging Act into law, making California just the second state to ensure older Californians living with HIV don’t just continue to survive, but thrive.”

“Thanks to effective treatments, people with HIV are living longer than we could have ever imagined just a few decades ago and now a majority of people with HIV in California are over 50 years old. Unfortunately, our current health and social service systems are not yet prepared to address the unique needs of this population,” APLA Health Chief Executive Officer Craig E. Thompson said adding; “Many older people with HIV are long term survivors of the AIDS epidemic. They have lost countless loved ones and entire networks of social support. They also continue to face discrimination and alarming levels of stigma. We thank Senator Laird for his leadership on this historic bill to ensure that people aging with HIV have the resources and support they need to thrive and age with dignity.”

“We must ensure that LGBTQ seniors have the affirming care and support so they can age in peace with dignity,” stated Laird. “It’s incumbent upon us to not force individuals back into the closet for them to access adequate care. Once again, I’d like to applaud the Governor for his continued support of the LBGTQ community and to my colleagues for making this a priority bill.”

The HIV & Aging Act received unanimous bipartisan support through both chambers of the Legislature and is a legislative priority for the California Legislative LGBTQ Caucus.

Senate Bill 258 will go into effect January 1, 2022.

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AIDS and HIV

HIV & Aging Act sails through legislature; awaits Newsom’s signature

“When I was Santa Cruz AIDS Agency Director, it was our dream to have people living with HIV age into the senior category.”

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California State Senator John Laird (D-Santa Cruz) (Photo courtesy of the Senate of State of California)

SACRAMENTO —  The California Assembly passed SB 258, the HIV and Aging Act, by Senator John Laird (D-Santa Cruz), Thursday sending the bill to Governor Newsom for signature. The bill advanced from the Assembly consent calendar and received no “no” votes in either chamber.

Pending Governor Newsom’s final approval, California will become only the second state — after Illinois in 2019 — to designate older adults living with HIV as a population of “greatest social need.”

“When I was Santa Cruz AIDS Agency Director, it was our dream to have people living with HIV age into the senior category,” said Senator Laird. “To be very clear, this group was not supposed to grow old. While the drug cocktail transformed the fight against HIV, and there are more HIV positive seniors than ever before, older people living with HIV face a number of behavioral health challenges in addition to physical illnesses. By easing the burden of connecting this vulnerable population to supportive aging services and programs, this bill provides another life line to assist this uniquely disadvantaged group.

“I would like to express my utmost thanks to the sponsors of SB 258 for their steadfast partnership and the large coalition of supporters who highlighted the critical need for historic recognition and support of those living with HIV.”

With recent advancements in HIV treatment, people with HIV who take antiretroviral therapy can keep the virus suppressed and live long and healthy lives. For this reason, the number of older people living with HIV is increasing and over half of people living with HIV in California are now aged 50 years or older. However, older people with HIV continue to face unique challenges and barriers in health and well-being. A 2020 report by SAGE’s HIV and Aging Policy Action Coalition (HAPAC) identified that older people with HIV are more likely than their HIV-negative counterparts to have multiple comorbidities, including certain cancers, cardiovascular disease, fractures, and hepatitis C. Older people with HIV also face a number of behavioral health challenges, including rates of depression up to five times greater than their HIV-negative peers and greater levels of stigma, social isolation and loneliness.

“As a person living with HIV since 1983, I thank the Assembly for passing SB 258 – the HIV & Aging Act – recognizing older adults with HIV face unique and profound challenges as a population of ‘greatest social need.’” said Tez Anderson, Executive Director of Let’s Kick ASS-AIDS Survivor Syndrome. “For too long, survivors of the AIDS pandemic have been overlooked and forgotten. None of us imagined aging, but over half of all Californians living with HIV are aging and urgently in need of social services and programs which address our physical and mental health. I urge Governor Newsom to sign the bill and give us hope for a better quality of life.”

The HIV & Aging Act updates the Welfare and Institutions Code to ensure older people living with HIV — who are likely to turn to government and community-based services due to multiple comorbidities, behavioral and mental health issues and limited social support — have access to the programs and services administered through the California Department of Aging. The legislation is co-authored by Senators Toni Atkins (D-San Diego), Susan Talamantes Eggman (D-Stockton), Scott Wiener (D-San Francisco) and Assemblymembers Sabrina Cervantes (D-Corona), Alex Lee (D-San Jose), Evan Low (D-Campbell) and Chris Ward (D-San Diego) and co-sponsored by APLA Health, Equality California, the Los Angeles LGBT Center and SAGE.

“Thanks to effective treatments, people with HIV are living longer than we could have ever imagined just a few decades ago,” said APLA Health Chief Executive Officer Craig E. Thompson. “Unfortunately, our current health and social service systems are ill-equipped to address the unique needs of this population. Many older people with HIV are long term survivors of the AIDS epidemic. They have lost countless loved ones and entire networks of social support. They experience significantly higher rates of depression, anxiety and other comorbidities. They also continue to face discrimination and alarming levels of stigma. APLA Health urges Governor Newsom to sign SB 258 into law to ensure that California’s aging network is prepared to support the state’s rapidly growing population of people aging with HIV.”

“As the number of older people living with HIV continues to increase, so should our state’s commitment to support this resilient population,” said Equality California Legislative Director Tami A. Martin. “We are thrilled that SB 258 received overwhelming, bipartisan support in the California legislature, and we look forward to pro-equality champion Governor Newsom signing this timely bill into law. Older Californians living with HIV deserve to have the resources and support they need to thrive with dignity.”

“SAGE applauds California State Senator John Laird and his colleagues for taking action in support of LGBT elders and people living with HIV,” said SAGE Director of Advocacy Aaron Tax. “This legislation would update the Older Americans Act in California, which funds critical programs like Meals-on-Wheels, to designate older people living with HIV as a target population. As older people living with HIV continue to face challenges in getting the aging services and supports that they need, it’s time for the law to catch up with the aging of the epidemic. Everyone should have access to the aging services and supports that they need, regardless of their identity or HIV status. This legislation will bring us closer to that reality.”

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AIDS and HIV

UCLA Fielding School awarded $5.2 million in grants for HIV prevention

The grants will study the use of a variety of techniques – personalized, daily text message reminders; and individual and group counseling

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UCLA Fielding School of Public Health Photo Credit: UCLA

LOS ANGELES – A team of researchers co-led by UCLA Fielding School of Public Health epidemiology professor Dr. Matthew Mimiaga has received more than $5.2 million in grants from the U.S. National Institutes of Health (NIH) to develop and test interventions in the U.S. and Brazil.

The projects, funded by three separate NIH grants, all have the goal of reducing the spread of HIV, the virus that causes AIDS, through the use of antiretroviral medications for HIV primary (PrEP) and secondary (ART) prevention among sexual and gender minority groups.

“Whether used as PrEP for HIV negative individuals or as ART treatment as prevention for those living with HIV, antiretroviral medications are highly effective at reducing HIV acquisition and transmission, but its efficacy is highly dependent on uptake and excellent adherence,” said Mimiaga, director of the UCLA Center for LGBTQ Advocacy, Research & Health. “However, sexual and gender minority groups face specific barriers to PrEP and ART access, uptake, adherence, and retention in care. Because of this, we are testing interventions that are culturally-tailored to address the lived realities and barriers among these vulnerable groups.”

The grants, announced by the NIH this month, will study the use of a variety of techniques – personalized, daily text message reminders; video vignettes; peer navigation; and individual and group counseling – to facilitate access and adherence to antiretroviral medications among those who would benefit the most from its use. These grants will be implemented in Los Angeles County; Providence, RI; Boston, MA; and Rio de Janeiro, Brazil.

This will give the researchers a wide variety of data on how these approaches work for different populations, ranging from LGBTQ adolescents, ages 15-24, to transgender women, and men who engage in transactional sex with other men. Dr. Katie Biello, a Brown University behavioral and social sciences and epidemiology professor, will co-lead this work with Mimiaga.

“Our goal is to develop HIV prevention interventions that are highly scalable and sustainable in the real world,” Biello said. “As such, this work takes into account the future of PrEP and ART access, while simultaneously addressing the barriers surrounding access, aiding in navigating linkage to PrEP and ART care programs, and reducing barriers to, and building skills to support, medication adherence.”

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