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HIV research sped development of COVID vaccine

Top NIH official says success in coronavirus will boost AIDS work

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‘In many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines,’ Carl W. Dieffenbach, Ph.D.

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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Florida

Gay Fla. Democrat Elijah Manley sees opportunity in Trump’s second term

State’s 20th Congressional District’s includes Broward, Palm Beach Counties

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Elijah Manley (Photo courtesy of the Elijah Manley campaign)

Just over two and a half miles from President Donald Trump’s primary residence lies one of Florida’s most reliably Democratic congressional districts. There, a 27-year-old progressive is mounting a campaign centered on resisting what he calls the Trump-Vance administration’s attacks on civil rights, immigrants, and LGBTQ Americans.

Elijah Manley, an openly gay Democrat, sat down with the Washington Blade to discuss why he is running for Florida’s 20th Congressional District, why he believes this moment calls for a new generation of leadership, and what he hopes to accomplish if elected to Congress.

Born and raised in Fort Lauderdale’s historic Sistrunk neighborhood — the city’s oldest African American community — Manley was raised by a single mother who struggled to make ends meet. His family experienced housing insecurity and, at one point, homelessness, experiences he says continue to shape both his politics and his policy priorities.

For Manley, those experiences are precisely what he believes Congress is missing.

“I think now the country is in need of somebody like me, with my story, my lived experience, the struggles I’ve been through in my life. We’re going through a really dark time in the country with the Trump administration coming for our civil rights and an economy that is not working for everybody. In a time where we have MAGA fascism, we need progressive leadership, and we need people who are really going to do the work of fighting back and resisting and obstructing Donald Trump and MAGA Republicans’ agenda in Congress.”

Manley said his campaign is also about ensuring people from marginalized communities — those without wealth, political connections, or institutional backing — have a voice in Congress.

“I think my story sets me aside from everyone else. I’m the only one in this race who has a story to tell voters that lines up with their lived experiences and their struggles. Growing up in poverty and experiencing homelessness was instrumental in developing my worldview and how I fight for people, and I think that’s something that’s absent on Capitol Hill.”

He argues that lived experience offers a perspective often missing on Capitol Hill.

“There are too many lawyers and people coming from professional and political backgrounds. Then you have somebody like me who is rooted in the story of this district. That’s what sets me apart from everyone else in this race.”

According to his campaign website, Manley’s interest in public service dates back to childhood. He cites the election of President Barack Obama as a defining moment that inspired him to pursue politics.

“He was inspired by Barack Obama’s historic election, igniting his passion for public service. He began writing to elected officials, speaking at school board and city council meetings, and advocating for issues affecting his community,” the website states. It goes on to describe his involvement in criminal justice and law magnet programs, Navy JROTC, and hundreds of hours of volunteer service while in high school.

Elijah Manley (Photo courtesy of the Elijah Manley campaign)

As an openly gay candidate running during Trump’s second administration, Manley said Congress must take a far more aggressive approach to protecting LGBTQ Americans, particularly as Republican-led states continue passing restrictions targeting transgender people.

“I think we need to bring the hammer down on some of these states. I’m not one of these states’ rights people — Congress has the power to preempt laws that states pass through the Supremacy Clause. There’s never been a more important time in our history when we’re seeing fascism, we’re seeing an administration out of control, and we need Congress to act.”

His campaign has also drawn criticism from both Republicans and establishment Democrats for his positions on Gaza, immigration, and his call to abolish U.S. Immigration and Customs Enforcement.

Manley said abolishing ICE does not mean eliminating immigration enforcement altogether.

“I’m not saying there should be no immigration laws. We want laws around immigration, but we want dignity. We don’t need a hypermilitarized, paramilitary group chasing people through the streets, terrorizing communities, churches, schools, and families.”

His personal experiences also inform his healthcare agenda.

“When we talk about healthcare, my experience growing up on Medicaid is seeing the failure of the government to expand Medicaid here in Florida, and now we’re seeing cuts from the Trump administration. I’m not just looking at statistics or numbers on paper — this is based on lived experience. I know how the people in this district are going to be hurt by these policies because I’ve lived it.”

California Democratic Congressman Ro Khanna, who has generated early buzz as a potential 2028 presidential contender for his “progressive capitalist” approach to governing, has endorsed Manley’s campaign, giving the first-time congressional candidate one of his highest-profile endorsements.

Manley faces six other Democrats in the primary, including U.S. Rep. Debbie Wasserman Schultz and former U.S. Rep. Sheila Cherfilus-McCormick, along with four Republican candidates in the general election field. Cherfilus-McCormick resigned from Congress ahead of a potential expulsion and is running again while facing federal criminal charges.

Despite running as the youngest candidate in the field, Manley said he hopes voters leave the race remembering one thing above all else.

“I want people to remember bold and authentic leadership. I want them to know I’m running because I’ve been through what people are going through right now — and it’s not that I’ve been through it, I’m actually still going through it. We need bold people who are going to fight for everybody and stand up for what’s right, and that’s what I hope voters see when they go to the polls.” 

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Florida

Former Fla. gubernatorial candidate Andrew Gillum arrested on drug charges 

Democrat narrowly lost to DeSantis in 2018, later came out as bisexual

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Andrew Gillum in 2020. (Photo public domain)

Andrew Gillum, the former Democratic nominee for governor of Florida and former mayor of Tallahassee, was arrested on drug possession charges in Alabama last week.

Police in Daphne, Ala., said they pulled Gillum over for erratic driving and found marijuana and methamphetamine in his vehicle. He was charged with possession of marijuana and unlawful possession of a controlled substance, according to the Daphne Police Department. Jail records show he was arrested on July 2 and released on July 3, the Associated Press reports.

Gillum, the first Black nominee of a major political party for governor in Florida, lost the 2018 election to current Republican Gov. Ron DeSantis in a highly contentious race.

Once considered a rising star in national politics, Gillum served in Tallahassee’s local government, first as a city commissioner and then as mayor of Florida’s capital from 2014- 2018.

The Daphne Police Department said officers stopped Gillum’s vehicle around 10:45 p.m. and initiated a probable cause search after one officer noticed a glass pipe on the center console.

During the search, officers found several rolled marijuana cigarettes and three packages containing a substance that tested positive for methamphetamine, police said.

The day after his arrest he was charged with possession of dangerous drugs, use or possession of drug paraphernalia, and possession of marijuana.

In 2020, Gillum was involved in a similar incident when he was found in a Miami Beach, Fla., hotel room with a man identified as an escort who had apparently overdosed on drugs. Police also found three bags of suspected crystal methamphetamine in the room. The man survived, and no one was ever charged with a crime.

Later that year, Gillum came out as bisexual during an appearance on “The Tamron Hall Show,” where he discussed his struggles with drug and alcohol addiction and his decision to seek treatment following the 2020 incident.

In the same interview he shed light onto this, saying his substance use was a byproduct of the emotional struggles he experienced after losing the 2018 gubernatorial race to DeSantis.

This is not the first time Gillum has faced legal scrutiny.

During his 2014 mayoral campaign, he faced allegations of misconduct after hiring private equity investor Adam Corey as his campaign treasurer, raising questions about a potential conflict of interest. However, the FBI ultimately concluded there was no conflict of interest.

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Pennsylvania

Philadelphia murder suspect remains at large

Two killed, one injured in attacks motivated by victims’ sexual orientation

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Jahylin Melchur, 21, is wanted in connection with three Philadelphia shootings, including two murders, who may have targeted his victims because they were gay. (Photos courtesy Philadelphia Police Department)

Police seek the public’s support in finding a suspect wanted in connection with three Philadelphia shootings, including two murders, who may have targeted his victims because they were gay. All three shootings took place near Hunting Park Recreation Center between May 29 and June 26.

The suspect is 21-year-old Jahylin Melchur, who has not been located by police and is not in police custody as of July 7. Police seek the public’s support in tracking down the suspect, whose image was captured on surveillance cameras. Previous reporting underlined that Melchur should be considered armed and dangerous.

Each of the victims was found partially clothed between 10 and 11 p.m.

On May 29, a 55-year-old in Juniata Park was found two miles from the rec center. The victim, who survived the encounter with critical injuries, said a man approached him and announced his intention to rob him, before shooting him in the elbow and torso.

Martin Higgins, 45, was pronounced dead on the bleachers of the rec center’s baseball field on June 20, suffering from a gunshot wound to the abdomen. Sharef Holman, 29, was found near the basketball courts on June 26, suffering from multiple gunshot wounds. He was transported to Temple University Hospital but died shortly thereafter.

Deputy Police Commissioner Frank Vanore declined to answer the Philadelphia Inquirer’s question regarding whether the victims may have met Melchur on a dating app, citing the ongoing investigation. Sources told the Philadelphia Inquirer that investigators are exploring this possibility

Although robbery may be at least part of the motive in the first shooting, other movies are unclear.

NBC10 reported that law enforcement sources told the station all three victims were targeted because they were gay, but the Philadelphia Police Department did not confirm this.

The Philadelphia Police Department replied to PGN’s questions with an email stating, “This remains a very active investigation, and investigators are looking at all aspects of the case, including underlying motivations for committing these crimes.

“At this point, we can confirm that Melchur is wanted for two homicides by shooting and one non-fatal shooting, all of which occurred in the Hunting Park area. 

“The investigation has not established that the victims were specifically targeted because of their sexual orientation.”

The Philadelphia Police Department is urging anyone with information to contact the Homicide Unit at 215-686-3334 or submit an anonymous tip by calling the PPD Tip Line at 215-686-TIPS (8477).

(This story is republished with permission of the Philadelphia Gay News.)

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