National
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.
Michigan
Progressives score victory as El-Sayed wins Mich. Senate primary
Democratic newcomer will face Rogers in November
Michigan held its primary on Tuesday, allowing the two major political parties to select their nominees to go head-to-head for the state’s U.S. Senate seat.
NBC News called the Democratic race early, giving the victory to physician Abdul El-Sayed over incumbent U.S. Rep. Haley Stevens (D-Mich.) in an extremely close primary. El-Sayed won 48.5 percent of the primary vote, with Stevens trailing by just one percentage point at 47.5 percent.
Both candidates have campagined on supporting the LGBTQ community through different avenues— for El-Sayed he focused on his past promoting HIV and PrEP funding and research. Stevens focused on her legislative history working to support transgender rights in the state.
This is a major win for progressive Democrats, who have been bearing the brunt of political attacks from President Donald Trump, the Republican Party, and centrist Democrats.
El-Sayed, a former health director in Detroit, ran his campaign largely on making life in the Great Lakes State more affordable amid rising costs. His policies include promoting “Medicare for All,” pushing health policy that targets the regressive efforts of the Trump-Vance administration that rolls back funding for both Women and LGBTQ people, minimizing the growing amount of money in politics, and he was very vocal in his criticism of Stevens for supporting aid to Israel. He was endorsed by two major progressives — U.S. Sen. Bernie Sanders (I-Vt.) and U.S. Rep. Alexandria Ocasio Cortez (D-N.Y.).
Stevens, the four-term congresswoman, is much closer to establishment Democrats on policy than El-Sayed.
During her time in the federal government, she has consistently supported the Equality Act, which would add sexual orientation and gender identity as protected classes under the Civil Rights Act of 1964. She has also emphasized supporting local manufacturing and lowering housing costs in the state.
She was named to Advocates for Trans Equality’s 118th Congressional Champions list for her pro-trans policies and was endorsed by establishment heavy hitters Michigan Gov. Gretchen Whitmer and Senate Minority Leader Chuck Schumer (D-N.Y.).
The contentious race boiled down not only to Michigan affairs but also extended to international conflicts — namely Palestine. (South Africa has filed a case in the International Court of Justice in The Hague that accuses Israel of committing genocide in the Gaza Strip after Oct. 7.) This primary also acted as one of the first major races that pushed back against AIPAC, a lobbying group that works to promote pro-Israel candidates in U.S. elections. The group has been involved in domestic politics since 1954.
AIPAC devoted a massive amount of money to this race.
The Associated Press reported that the pro-Israel lobbying group spent more than $30 million on ads against El-Sayed because of his vocal denunciation of Israel and his continued criticism of its policies towards Palestine.
Michigan has a large Muslim and Arab American population, which could, in part, explain how El-Sayed was able to win.
The Republican side was far less competitive. Former U.S. Rep. Mike Rogers (R-Mich.) ran unopposed and clinched the GOP nomination. He has consistently held anti-LGBTQ positions, going as far as voting multiple times for a federal constitutional amendment to ban same-sex marriage, voting against repealing the military’s “Don’t Ask, Don’t Tell” policy, and supporting efforts to directly target the attempted expansion of Title IX protections to include trans people.
El-Sayed will face off against Rogers in November for Michigan’s Senate seat — one that could have lasting impacts not only on the state’s politics but also on the Republicans’ narrow Senate majority and Trump’s political agenda.
National
White House orders warning signs at Smithsonian over gender identity exhibits
Administration criticizes National Museum of American History
The Trump administration will install temporary warning signs outside the Smithsonian’s National Museum of American History after releasing a report accusing the museum of promoting what it calls “radical” gender ideology and other politically biased content.
According to the Executive Order, “For purposes of policy formulation under EO 14253, this review of the National Museum of American History concludes that NMAH, by the intention and at the direction of current Museum and Smithsonian leadership, has become subject to institutional capture by a radical, activist ideology that is fundamentally opposed to telling the noble, honest story of the great country we know and love.”
Executive Order 14253 refers to what the White House has deemed the “Restoring Truth and Sanity to American History” order. Therefore, the Trump administration has said it will take all available steps to ensure that the issues in the report are addressed and rectified.
Without specifying, the White House has stated that warnings will be posted along NMAH to alert visitors to sections of the museum it has deemed are in violation according to the report.
“The Secretary of the Interior, acting through the Director of the National Park Service (NPS) and in coordination with the Assistant to the President for Domestic Policy, shall install temporary signage along the NPS-maintained sidewalks and walkways used by the public to access the Museum, informing visitors of the findings of the Report and of the policy set forth in section 1 of this order,” the Executive Order states.
The warnings were raised in a 162-page report issued by the Domestic Policy Council. The report detailed ways in which the National Museum of American History (NMAH) has “poorly” portrayed American history and insufficiently highlighted the founding story during America 250th celebrations.
The report outlined key findings of the NMAH. One of these findings was the Center for Restorative History within the museum, which has stated its purpose is to “encourage systemic change” by highlighting diverse groups. However, the report states that it highlights every group of Americans except for straight and white Americans.
The Domestic Policy Council accused the museum of engaging in “transgender activism.” According to the report, examples include referring to “biological men” as women or girls, displaying what it describes as sexually suggestive content, and incorporating discussions of gender fluidity, gender identity, and gender nonconformity into the museum’s educational curriculum, “Becoming US.”
The report also criticizes the curriculum for using the term “transgender” when discussing gender-nonconforming people and encouraging individuals to ask a person’s pronouns when meeting them. It further objects to exhibits stating that “transgender, nonbinary, and cisgender female athletes” continue to struggle for and demand equality.
It also condemns what it refers to as explicit content in an exhibition, “Girlhood (It’s Complicated)”, such as chest binders, questioning gender testing in women’s sports, and referring to biological females as “people inhabiting female bodies.”
Additionally, the report accuses the museum of no longer participating in flag-celebrating ceremonies because it was “too busy” preparing for June Pride and WorldPride events. It states, “As Director Hartig explained in a June 2024 presentation, all her attention was focused on flying the Smithsonian Pride Alliance’s ‘intersexual pride flag during June’ in 2023 and 2024.”
On July 9, the American Historical Association issued a statement rejecting the report’s findings.
In regard to the report, it states, “Its anonymous authors overlook a central lesson of the nation’s founding: the United States was forged by finding common purpose amid intense divisions, conflicts, and disagreements.” They argue that only “honest history” can tell the true history of the nation.
House Republicans led a subcommittee hearing that questioned Smithsonian Director Hartig extensively. A main focus of the questions was on the exhibits related to gender identity and whether they were appropriate. In the hearing, Rep. Nancy Mace asked: “When was your gender revealed to you, Dr. Hartig?”
In response to questioning, Hartig stated that the institution is nonpartisan and does not push a specific agenda.
Hartig published a two-page statement ahead of her hearing outlining her thoughts on the situation. In the report, she states that the institution is always open to criticism and will continue to look for ways to improve, but she sees the report as misleading.
“I can attest that the report does not fairly characterize the full body of work at this museum. I am familiar with the depth and breadth of our collections, exhibits, and programming. And while I recognize there is always room for improvement, I also know the beauty, inspiration, and expertise that exists in our museum,” Hartig wrote.
Democrats created their own 16-page report as a rebuttal to the Domestic Policy Council’s report. It argued that the attacks by the current Trump administration are another example of its attempt to rewrite history. Additionally, the report states that no policy changes were included in the Executive Order, as that is beyond the President’s role. “The Report recommends nothing. That is no accident. To recommend an action, the Report would need to identify who is legally empowered to take it, and its own opening chapter concedes the President’s only power is to ‘urge’,” House Democrats wrote.
It is still unclear when the temporary warnings will be installed or what form they will take beyond the requirements outlined in the executive order.
An exhibit at the Smithsonian. (Washington Blade photo by Landon Shackelford)
National
Trump ends direct HIV prevention funding to community groups
Advocates say transfer of funds to states may disrupt local programs
A decision by the U.S. Office of Management and Budget (OMB) at the request of the Trump administration to discontinue direct federal funding of community-based organizations and clinics that provide HIV prevention services has raised concern among community health advocates, including LGBTQ advocates.
News surfaced earlier this month that the OMB informed the U.S. Centers for Disease Control and Prevention that it would not renew $46 million in funding for 96 community-based organizations that provide HIV testing, referrals to medical care, and arrangements for obtaining pre-exposure HIV prevention medication known as PrEP that has been shown to be 99 percent effective in preventing HIV infection.
Under the new policy arranged by OMB, the funds will be redirected to the states to be allocated to state and local health departments. The policy calls for states to encourage but not require their respective state and local health departments to allocate some of those funds for community-based organizations. Under the new policy, the funding is scheduled to last until May of 2027, before a renewal decision is made.
Some political observers have speculated that the decision to end direct federal funding to community-based organizations could be motivated by the Trump administration’s hostility to diversity, equity, and inclusion or DEI programs and organizations that promote those programs, with the belief that some of the groups receiving the federal HIV prevention funds are promoting DEI.
Carl Schmid, executive director of the D.C.-based HIV+ Hepatitis Policy Institute, is among the leaders of many AIDS advocacy organizations expressing strong opposition to the OMB action. Schmid said that in places like D.C. and some states, local officials will be willing to redirect the federal funds to local community-based organizations.
A list of the 96 community-based organizations across the country that are currently receiving the federal AIDS funds includes the D.C.-based Whitman-Walker Health, which has a long history of healthcare support for the LGBTQ community, and La Clinica del Pueblo, which reaches out to the Latino community.
Schmid said Whitman-Walker and La Clinica del Pueblo have longstanding good relationships with the local D.C. government.
“But other states and jurisdictions don’t have that relationship with the community-based organizations,” Schmid said. “It depends on the state,” he said, adding, “Not all states send their money to the communities that really need it most. And not all states are fast in getting money to the community-based organizations.”
Spokespersons for Whitman-Walker and La Clinica del Pueblo couldn’t immediately be reached for comment on whether they think the Trump administration’s latest action related to funding will adversely impact their respective organizations.
Schmid said under the current federal grant program slated to be discontinued, which has been in effect for at least five years, HIV-related health organizations receiving the federal grant funds were eligible for an existing federal policy enabling them to purchase HIV-related medication, including the PrEP prevention medication, at a significant discount from pharmaceutical companies. With the ending of the direct federal HIV funds to community-based organizations, Schmid said it was unclear whether problems may surface in obtaining drug discounts.
“They could still qualify as a sub-grantee from a state,” Schmid said. “But what if they don’t get that grant again? They would not be able to qualify to obtain the drugs” at the discounted price, he said.
Among the organizations expressing strong concern over the decision to discontinue the direct HIV prevention funding to community-based organizations has been the Federal AIDS Policy Institute and its subgroup called the HIV Prevention Action Coalition.
In a July 22 letter bearing the names of 71 community-based organizations from throughout the country sent to U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Centers for Disease Control and Prevention Acting Director Jay Bhattacharya, the group called for the Trump administration to “reconsider” ending the current funding policy.
“Ending this program without a clear plan for what comes next would dismantle prevention infrastructure that has taken more than three decades of federal investment to build and do so just as that long record of measurable returns is accelerating,” the letter states.
It says the initiative by President Trump in his first term as president to end the HIV epidemic and reduce new HIV infections by 90 percent by 2030 was moving ahead by the funding program for community-based organizations that the administration now wants to end.
“Discontinuing this program would also cost far more than it saves,” the letter says. “Every HIV transmission prevented avoids an estimated lifetime treatment cost of roughly half a million dollars per person to the healthcare system – costs that fall heavily on taxpayer-funded programs, including Medicaid, Medicare, and the Ryan White HIV/AIDS program,” the letter continues.
“The choice before the administration is straightforward: a modest, targeted investment in prevention now, or far greater public expense for treatment later,” the letter concludes.
Spokespersons for the OMB and the Department of Health and Human Services, which oversees the CDC, have not immediately responded to news media requests for comment on the opposition to the funding change policy.
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