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.
Tennessee
Tenn. lawmakers pass transgender “watch list” bill
State Senate to consider measure on Wednesday
The Tennessee House of Representatives passed a bill last week to create a transgender “watch list” that also pushes detransition medical treatment. The state Senate will consider it on Wednesday.
House Bill 754/State Bill 676 has been deemed “ugly” by LGBTQ advocates and criticized by healthcare information litigators as a major privacy concern.
The bill would require “gender clinics accepting funds from this state to perform gender transition procedures to also perform detransition procedures; requires insurance entities providing coverage of gender transition procedures to also cover detransition procedures; requires certain gender clinics and insurance entities to report information regarding detransition procedures to the department of health.”
It would require that any gender-affirming care-providing clinics share the date, age, and sex of patients; any drugs prescribed (dosage, frequency, duration, and method administered); the state and county; the name, contact information, and medical specialty of the healthcare professional who prescribed the treatment; and any past medical history related to “neurological, behavioral, or mental health conditions.” It would also mandate additional information if surgical intervention is prescribed, including details on which healthcare professional made a referral and when.
HB 0754 would also require the state to produce a “comprehensive annual statistical report,” with all collected data shared with the heads of the legislature and the legislative librarian, and eventually published online for public access.
The bill also reframes detransitioning as a major focus of gender-affirming healthcare — despite studies showing that the number of trans people who detransition is statistically quite low, around 13 percent, and is often the result of external pressures (such as discrimination or family) rather than an issue with their gender identity.
This legislation stands in sharp contrast to federal protections restricting what healthcare information can be shared. In 1996, Congress passed the Health Insurance Portability and Accountability Act, or HIPAA, requiring protections for all “individually identifiable health information,” including medical records, conversations, billing information, and other patient data.
Margaret Riley, professor of law, public health sciences, and public policy at the University of Virginia, has written about similar efforts at the federal level, noting the Trump-Vance administration’s push to subpoena multiple hospitals’ records of gender-affirming care for trans patients despite no claims — or proof — that a crime was committed.
It has “sown fear and concern, both among people whose information is sought and among the doctors and other providers who offer such care. Some health providers have reportedly decided to no longer provide gender-affirming care to minors as a result of the inquiries, even in states where that care is legal.” She wrote in an article on the Conversation, where she goes further, pointing out that the push, mostly from conservative members of the government, are pushing extracting this private information “while giving no inkling of any alleged crimes that may have been committed.”
State Rep. Jeremy Faison (R-Cosby), the bill’s sponsor, said in a press conference two weeks ago that he has met dozens of individuals who sought to transition genders and ultimately detransitioned. In committee, an individual testified in support of the bill, claiming that while insurance paid for gender-affirming care, detransition care was not covered.
“I believe that we as a society are going to look back on this time that really burst out in 2014 and think, ‘Dear God, What were we thinking? This was as dumb as frontal lobotomies,’” Faison said of gender-affirming care. “I think we’re going to look back on society one day and think that.”
Jennifer Levi, GLAD Law’s senior director of Transgender and Queer Rights, shared with PBS last year that legislation like this changes the entire concept of HIPAA rights for trans Americans in ways that are invasive and unnecessary.
“It turns doctor-patient confidentiality into government surveillance,” Levi said, later emphasizing this will cause fewer people to seek out the care that they need. “It’s chilling.”
The Washington Blade reached out to the American Civil Liberties Union of Tennessee, which shared this statement from Executive Director Miriam Nemeth:
“HB 754/SB 676 continues the ugly legacy of Tennessee legislators’ attacks on the lives of transgender Tennesseans. Most Tennesseans, regardless of political views, oppose government databases tracking medical decisions made between patients and their doctors. The same should be true here. The state does not threaten to end the livelihood of doctors and fine them $150,000 for safeguarding the sensitive information of people with diabetes, depression, cancer, or other conditions. Trans people and intersex people deserve the same safety, privacy, and equal treatment under the law as everyone else.”
National
Glisten’s 30th annual Day of Silence to take place April 10
Campaign began as student-led protests against anti-LGBTQ bullying, discrimination
Glisten’s 30th annual Day of Silence will take place on April 10.
The annual Day of Silence began as a student-led protest in response to bullying and discrimination that LGBTQ students face. It is now a national campaign for the LGBTQ community and their allies to come together for LGBTQ youth.
It takes place annually and has multiple ways for supporters to get involved in the movement.
Glisten, originally GLSEN, champions LGBTQ issues in schools, grades K-12. Glisten’s mission is to create more inclusive and accepting environments for LGBTQ students through curriculum, supportive measures, education campaigns, and engagement, such as the Day of Silence.
There are three main ways for the community to get involved in the Day of Silence.
Glisten has a Day of Silence frame, a series of pictures used as profile photos across social media that feature individuals holding signs. The signs allow for personalization, by providing a space to put the individual’s name, followed by filling in the prompt “ … and I am ENDING the silence by…”
Participants are encouraged to post the photo on social media and use it as a profile picture. The templates can be found on Google Drive through this link.
Using #DayOfSilence and #NSCS, as well as tagging Glisten’s official Page @glistencommunity, is another way to participate in the Day of Silence.
Glisten also encourages participants to tag creators, friends, family and use a call to action in their caption, to call attention to the facts and stories behind the Day of Silence.
“Today’s administration in the U.S. wants us to stay silent, submit to their biased and hurtful conformity, and stop fighting for our right to be authentically ourselves,” said Glisten CEO Melanie Willingham-Jaggers. “We urge supporters to use their social platforms and check in with local chapters to be boots on the ground to help LGBTQ+ students feel seen, heard, supported, and less alone. By participating in the ‘Day of Silence,’ you are showing solidarity with young people as they navigate identity, safety, and belonging. Our voices matter.”
South Carolina
Man faces first S.C. ‘hate intimidation’ charge
Timothy Truett allegedly shot at gay club in Myrtle Beach on April 1
A South Carolina man remains in custody on a more than $300,000 bond after he allegedly opened fire at a Myrtle Beach nightclub on April 1, according to WMBF.
Reports say 37-year-old Timothy James Truett Jr., of Clover, S.C., was detained by the Myrtle Beach Police Department after the April 1 incident outside Pulse Ultra Club. He was later arrested and charged with possession of a weapon during a violent crime, discharging a firearm into a dwelling, discharging a firearm within city limits, malicious injury to real property valued over $5,000, and assault or intimidation due to political opinions or the exercise of civil rights.
At 10:57 a.m. on April 1, officers responded to a call about a possible shooting at Pulse Ultra Club, located in the 2700 block of South Kings Highway.
In an affidavit released later, the club’s owner, Ken Phillips, said he was doing paperwork that morning when he heard “five or six” gunshots. He went outside and found a window and the windshield of his SUV shattered by bullets. An SUV with blue plastic covering one window was left at the scene.
Police later reviewed footage that showed a silver vehicle stopping in the middle of the road. The video appeared to capture muzzle flashes coming from the passenger-side window.
According to the affidavit, an officer later pulled over a vehicle driven by Truett and found spent shell casings in the back seat, along with a gun.
Documents do not detail why Truett was ultimately charged under the state law covering assault or intimidation tied to political opinions or the exercise of civil rights.
As of April 1, records show Truett is being held in Horry County on a combined bond of more than $312,000.
WMBF spoke with Phillips after the incident and asked whether there was any prior conflict that might have led to the shooting.
“I don’t know if it’s personal, I don’t know if it’s related to being gay, I don’t know if it’s related to the bar issues,” Phillips told WMBF. “Anybody with a mindset of pulling out a weapon in broad daylight is not right.”
“My primary concern has and always will be the safety of my community and my customers,” he added. “It’s given me great concern … as to how far people will go.”
WMBF also spoke with Adam Hayes, vice chair of Myrtle Beach’s Human Rights Coalition, who was involved in pushing for the ordinance. He said that while the incident itself is troubling, it shows the policy is being put to use.
The ordinance is intended to deter “crimes that are motivated by bias or hate towards any person or persons, in whole or in part, because of the actual or perceived” identity, in the absence of a statewide hate crime law.
“It’s nice to see that something we put into policy is not just a piece of paper, that it’s actually being used,” said Hayes.
He said the shooting underscores the need for a statewide hate crime law in South Carolina and added that the incident has left the local LGBTQ community shaken.
South Carolina and Wyoming are the only two states in the U.S. without a comprehensive statewide hate crime law.
Truett remains in jail as of publication.
Trump’s war threats trigger rare 25th Amendment discussion
A Sondheim masterpiece ‘Merrily’ rolls onto Netflix
ROSENSTEIN: Vote McDuffie for mayor of D.C.
New book celebrates 1970s dance music icons
Report: Grenell wants Russian ambassadorship
Risking it all for love during World War II
D.C. is the place for the Democratic Socialists of America
PHOTOS: The Bonnet Ball
Key lifestyle changes can help patients cope with diabetes
