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HIV research sped development of COVID vaccine
Top NIH official says success in coronavirus will boost AIDS work
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.
National
Blade reporters reflect on covering Pulse massacre 10 years ago
Orlando stepped up to comfort and support its LGBTQ community
Friday marks 10 years since a gunman killed 49 people inside the Pulse nightclub in Orlando, Fla.
The massacre, which, at the time was the deadliest mass shooting in modern U.S. history, left the LGBTQ community in this country and around the world reeling. It also prompted renewed calls for gun control.
The OnePulse Foundation, which Pulse owner Barbara Poma founded after the massacre, raised upwards of $20 million for a memorial that never materialized.
The city of Orlando in 2023 purchased the Pulse property for $2 million. Crews earlier this year demolished the former nightclub. The city of Orlando has pledged $12 million for a permanent memorial that is scheduled to open in 2027.
Washington Blade Editor Kevin Naff and International News Editor Michael K. Lavers reported from Orlando in the days after the massacre. Here are their reflections a decade later.
Describe the scene when you arrived in Orlando. Where did you go first?
NAFF: Most mainstream reporters headed for the Pulse nightclub, but it was already roped off with police keeping bystanders at least a full city block away. Instead, I hurried to The Center, Orlando’s LGBTQ community center, downtown. I expected to find it locked down with tight security but instead the doors were flung open and everyone inside was busy at work. No tears, just dedicated staff and volunteers working the phones to secure visas and free plane tickets for relatives of the victims. The director gave me a tour and in the back storage room were pallets and pallets of bottled water stacked to the ceiling. When I asked what all the water was for, he said the city had issued a call for blood donations and the lines to donate were 1,500 deep in 100-degree heat. So The Center drove around to all the sites to deliver water to all those standing in line.
That scene was so inspiring and a testament to the strength and resiliency of the LGBTQ community. We’d seen tragedy before and knew how to respond.
LAVERS: I arrived in Orlando about 14 hours after the massacre took place. The city was shellshocked.
Equality Florida, the state’s LGBTQ advocacy group, and other organizations held a press conference at The Center shortly after my flight from D.C. landed. I drove there from the airport. Terry DeCarlo, who was The Center’s executive director at the time, along with then-Equality Florida Executive Director Nadine Smith and others spoke on behalf of a community that was reeling. The Center at the press conference handed out business cards that read, “You matter.” I had it in my wallet when I drove to a makeshift memorial that was a block from Pulse — the police had cordoned off the area immediately around the nightclub. A local resident who I interviewed told me that she did not know if her friends who were at Pulse when the gunman opened fire survived. Another person with whom I spoke shared a similar story.
A torrential downpour began shortly after I arrived. The storm was an apt metaphor for the raw emotion of that horrific day.
What’s your most prominent memory of covering the Pulse massacre?
NAFF: I was covering a vigil in downtown Orlando when then-Florida Gov. Rick Scott’s motorcade arrived unannounced. To that point, he had not addressed the LGBTQ angle and seemed to be downplaying the fact that this was an attack on our community. I hurried to the front row as he held an impromptu news conference. To my dismay, he took only three short questions from TV reporters then rushed away. I grabbed his communications director and insisted that Scott take a question from the LGBTQ media. She agreed and told me to wait next to the SUV. When Scott approached, I asked him, “What is your message to LGBTQ Floridians?”
To my surprise, he sputtered, stammered, and broke into tears before telling me, “This was an attack, what else can you say? This was an attack against the gays, an attack against Hispanics, an attack against our country, our nation and it’s disgusting. The biggest thing we do now is ask how to make sure this doesn’t happen again.”
It was his first public acknowledgment that the LGBTQ community was the target of the attack.
LAVERS: Two moments stand out for me.
The first moment is when then-President Barack Obama and then-Vice President Joe Biden traveled to Orlando on June 16, four days after the massacre. I was one of the reporters who the White House asked to be part of the local press pool. I was about 50 feet away from Obama and Biden when they placed bouquets with 49 flowers — one for each of the victims — at a makeshift memorial between City Hall and the Dr. Phillips Center for the Performing Arts in downtown Orlando. Obama in remarks he made to the press pool mentioned one of the gay victims who had once said, “We cannot be afraid.” The emotions of the last four days simply became too much, and I broke down. Another reporter who was part of the press pool who was standing next to me realized I had broken down. She put her hand on my back to console me.
The second moment came a few weeks later when I was in Puerto Rico to cover the community’s response to the massacre and to interview victims’ relatives. Orlando has a very large Puerto Rican community, and nearly half of those who died at Pulse were of Puerto Rican descent.
I drove to Caguas, a city that is roughly 20 miles south of San Juan, the island’s capital, on July 7, and interviewed Aida Velázquez in her small apartment. Her son, Frankie “Jimmy” de Jesús, died at Pulse. Aida talked about her son, and she showed me pictures of him. Jimmy also danced Jíbaro, a Puerto Rican folk dance. The interview took place less than a month after the massacre — Jimmy’s funeral took place in Caguas less than two weeks earlier.
I sat in my car after the interview and sobbed uncontrollably for nearly five minutes. Nothing can possibly prepare you for interviewing a mother who had just lost her child in the most horrific way possible.
How did the local community respond and what about their response gave you hope or inspiration?
NAFF: In addition to the staff at The Center working to assist victims and their families, everyday Orlando residents stepped up to help however they could. At the downtown vigils, straight mothers and fathers carried signs offering hugs to anyone who needed them. I encountered a group of young teenage males who approached a group of law enforcement officers and appeared to perform for them. When they finished, I asked what they were doing and they told me that they were straight friends who lived in Orlando and wanted to do something to help so they composed an uplifting rap song and walked around performing it for anyone who needed cheering up.
LAVERS: The way that Orlando rallied around the LGBTQ community was simply inspiring.
Imam Muhammad Musri, president of the Islamic Society of Central Florida, at a memorial service that took place at the Dr. Phillips Performing Arts Center on June 13 said his organization was “united as Americans when it comes to standing with the LGBT community and their rights to live freely and to practice their lives here.” This comment underscored the outpouring of support that Orlando showed its LGBTQ community after Pulse. It was also a call for the better angels among us to reject hate in all of its forms.
What surprised you most about the experience?
NAFF: I was most surprised — and moved — after talking to Rev. Debreita Taylor of Oasis Fellowship Ministries, an LGBTQ-affirming ministry.
“My message is love. Period. Love. Period. There’s nothing in the word of God that faith leaders can go to that teaches hate,” she told me. “Have faith and believe that evil and hate can be eradicated one person at a time. How do you treat someone? How do you embrace someone who treats you wrong? We all bleed, laugh, hope and have great victories and major defeats. And so, you know me, even if you don’t know my name — I’m you.”
LAVERS: It admittedly took me quite a while to fully process what I experienced in Orlando — I was focused on doing my job as a reporter, which was to cover the story, and, most importantly, show the human impact of what had happened. I suppose one surprising aspect of the time I spent in Orlando was that I found myself feeling more defiant against those who seek to destroy our community. They want us to live in fear, and I refuse to give them that satisfaction.
What, if anything, changed as a result of Pulse?
NAFF: In the immediate aftermath of the attack, queer spaces began rethinking their approach to security, which has served us well in the years since. Sadly, just a year later, Pulse was bumped to the No. 2 deadliest mass shooting in U.S. history when a gunman opened fire on the Route 91 Harvest music festival in Las Vegas, killing 60 people. Americans and their politicians never learn from these largely preventable tragedies. The carnage continues.
LAVERS: Gun violence remains a shameful scourge in this country. Our community remains vulnerable to violence and discrimination. President Donald Trump, Vice President JD Vance, and other politicians here in Washington, around the country, and overseas continue to use our community to advance an anti-equality agenda. The carnage continues, as my colleague correctly notes, but our community remains strong and defiant. That gives me hope.
National
Queen Jean is Tony’s first transgender winner
Designer/activist wins for work on ‘Cats: The Jellicle Ball’
It was a historic night at the 79th annual Tony Awards on Sunday as Queen Jean won the award for Best Costume Design of a Musical, making her the first out transgender person to win a Tony.
“This experience has been monumental. We are here for the legacy of queer people, trans people,” she said. “We are taking up space in ways we have to take up space. We have to shift the paradigm. So I just want to say, thank you all so much for this incredible honor. The world right now is deeply, deeply combating so many ailments, and we know as a society that when we come together, we can make real, permanent change.”
She won the award for her work on “Cats: The Jellicle Ball” and was also nominated for best costume design of a play for “Liberation.”
In addition to her stage work, Queen Jean is the founder of Black Trans Liberation, an organization that supports trans and gender-nonconforming people in New York City.
National
Madonna turns Times Square into massive dance floor
Pop icon celebrates Pride month with surprise performance
Pop icon Madonna celebrated Pride month with a pop-up performance in New York City’s Times Square on Thursday to the delight of 50,000 fans.
She performed for about 15 minutes high above street level, including several songs from her new album “Confessions II” due on July 3, along with a trio of songs from the first “Confessions on a Dance Floor.”
In addition to the brand new “Love Sensation,” she performed “I Feel So Free” and “Bring Your Love,” plus “Hung Up,” “Get Together” and “I Love New York.” She wished the crowd a happy Pride season; the event was shared with audiences through Grindr’s first-ever livestream.
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