Connect with us

National

HIV research sped development of COVID vaccine

Top NIH official says success in coronavirus will boost AIDS work

Published

on

‘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.

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

National

Federal prosecutors declined to prosecute 82% of hate crimes

DOJ report says ‘insufficient evidence’ was main cause

Published

on

U.S. Department of Justice

Federal prosecutors, who are referred to as United States Attorneys, declined to prosecute 82 percent of 1,864 suspects investigated for violating federal hate crime laws in all 50 states and D.C. during the years of 2005 to 2019, according to a newly released report by the U.S. Department of Justice’s Bureau of Justice Statistics.

The 15-page report, released on July 8, cites insufficient evidence as the reason suspects were not prosecuted in 55 percent of the federal hate crime cases. The report says “prioritization of federal resources” was the reason for a decision not to prosecute 15 percent of the suspects. 

It says 13 percent of the suspects were not prosecuted by U.S. Attorneys because the suspect was “subject to the authority of another jurisdiction,” and another 13 percent were not prosecuted because the federal government lacked legal jurisdiction to file a hate crime charge. 

The report, entitled Federal Hate Crime Prosecutions, 2005-2019, does not disclose the category of the victims targeted for a hate crime by the suspects whose cases were or were not prosecuted. 

In its annual hate crimes report as required under the U.S. Hate Crimes Statistics Act, the FBI provides information on hate crimes based on a victim’s race/ethnicity/ancestry; religious affiliation; sexual orientation; gender identity; disability; and gender.

The FBI’s most recent hate crimes report released in November 2020, and which covers the year 2019, shows that hate crimes based on a victim’s sexual orientation represented 16.8 percent the total number of hate crimes reported to the FBI for that year, the third largest category after race and religion. 

The FBI report shows that 4.8 percent of the total hate crimes reported to the FBI in 2019 were based on the victim’s gender identity. 

These figures suggest that at least some of the hate crimes cases that U.S. Attorneys declined to prosecute were cases involving LGBTQ people as victims. 

The Bureau of Justice Statistics report also does not disclose whether or how many of the suspects who were not prosecuted for a hate crime violation were prosecuted for the underlying criminal offense that was investigated by federal prosecutors as a possible hate crime.

Law enforcement officials, including D.C. police officials, point out that a hate crime is not a crime in and of itself but instead is a designation added to an underlying crime such as assault, murder, destruction of property, and threats of violence among other criminal offenses. Most state hate crimes laws, including the D.C. hate crimes law, call for an enhanced penalty, including a longer prison sentence, for a suspect convicted of a crime such as murder or assault that prosecutors designate as a hate crime. 

Tannyr M. Watkins, a spokesperson for the DOJ’s Bureau of Justice Statistics, told the Blade in response to a Blade inquiry that the bureau did not have access to data it received from U.S. Attorney’s offices throughout the country about whether hate crime suspects were prosecuted for an underlying crime when the U.S. Attorney’s declined to prosecute the suspect for a hate crime.

The Bureau of Justice Statistics report released last month says that out of the 17 percent, or 310, of the hate crime suspects who were prosecuted between 2005-2019, 92 percent, or 284, whose cases were brought before a U.S. District Court, were convicted. And 85 percent of those convicted received a prison sentence, the report says. 

“Forty percent of the 284 hate crime convictions during 2005-2019 occurred in federal judicial districts in six states – New York (30), California (26), Texas (19), Arkansas (15), Tennessee (13), and Pennsylvania (12),” the report states. It says that during this 15-year period all but 10 states saw at least one hate crime conviction. In addition, there were two federal hate crime convictions in D.C. during that period, according to the report.

The U.S. Attorney’s Office for the District of Columbia, unlike U.S. Attorneys in the 50 states, prosecutes criminal offenses under both D.C. law and federal law under D.C.’s limited home rule government. In the 50 states, most hate crimes are believed to be prosecuted by state and local prosecutors.

Former D.C. U.S. Attorney Jessie Liu has stated that the D.C. Office of the U.S. Attorney has prosecuted most criminal cases in which a hate crime arrest was made but the office dropped the hate crime designation due to lack of sufficient evidence. Liu said the office has continued to prosecute the suspect for the underlying charge, which often included a charge of assault or destruction of property.

The Bureau of Justice Statistics report says U.S. Attorneys use five federal hate crimes related statutes to prosecute suspects for hate crimes. Among them is the Matthew Shepard and James Byrd Jr. Hate Crimes Prevention Act of 2009, which is the only federal hate crimes law that includes protections for LGBTQ people.

LGBTQ activists hailed the Shepard-Byrd law as an important breakthrough because it authorizes federal prosecutors to prosecute anti-LGBTQ hate crimes in states whose hate crimes laws do not cover hate crimes based on the victim’s sexual orientation or gender identity.

Continue Reading

National

Threats of violence and death shuts down Nebraska drag queen story hour

After discussions and consultations with Lincoln Police, the museum and the LGBTQ+ group citing safety concerns cancelled the event.

Published

on

Screenshot of the Lincoln Children’s Museum, Lincoln, Nebraska. ABC News affiliate coverage

LINCOLN – A private LGBTQ+ event scheduled for after hours this past Saturday at the Lincoln Children’s Museum in Nebraska’s capital city was cancelled after the museum and the event’s organizers received a torrent of abusive violent threats including ones that were simply death threats.

Longtime local drag performer Waylon Werner-Bassen, who is the president of the board of directors of LGBTQ advocacy group OUTNebraska had organized the event alongside Drag Queen Story Hour Nebraska.

Bassen told the Lincoln Star-Journal in an interview last week on Tuesday that the scheduled RSVP only two-hour event, which was accessible through Eventbrite, had garnered a conformed attendee list of approximately 50 people.

Mandy Haase-Thomas, director of operations and engagement for the Lincoln Children’s Museum in an email the Star-Journal confirmed the event was invitation-only private, not sponsored by the museum and to be held after museum’s open-to-the-public hours.

According to Bassen, immediately after the event was announced the threats commenced, some of which included death threats. After discussions and consultations with officials from the Lincoln Police Department, the Lincoln Children’s Museum and Bassen’s group citing safety concerns cancelled the event.

Officer Luke Bonkiewicz, a spokesperson for the LPD said that the matter was under investigation and as such would not comment other than to acknowledge that the threats were found to be credible.

In an Instagram post the museum expressed its dismay over the event’s cancellation.

Community reaction was swift and uniformly in support of OutNebraska and the dreg queen story hour event with the city’s Mayor weighing in along with a supervisor with the Lincoln Police Department.

The ACLU of Nebraska along with other supporters which included state lawmakers Senator Adam Morfeld and Senator Tony Vargas also weighed in.

OutNebraska and the museum have both stated that they will reschedule the event. In a Facebook post Out Nebraska noted: “We look forward to working with Lincoln Children’s Museum to reschedule this as an entirely private event. It’s so sad when hate threatens families with children. All parents want their children to be safe. Because we could not be certain that it would be safe we will cancel this weekend and reschedule for another time — this time without a public portion of the invitation. We will be in touch with the families who have already registered with more information about when we are rescheduling.”

In related news the LPD not only recently celebrated LGBTQ Pride Month, but the designated person nominated at the end of June by the Mayor to be the department’s new Chief, is SFPD Commander Teresa Ewins, the San Francisco California Police Department’s highest-ranking LGBTQ member.

Continue Reading

National

FBI joins investigation into murder of LGBTQ Atlantan

Atlanta Police continue to search for the suspect in the deadly stabbing of a woman asking that anyone with information to please come forward

Published

on

Katie Janness and her dog Bowie via Facebook

ATLANTA – The Atlanta Police Department’s murder investigation into this past Wednesday’s stabbing death of 40-year-old Katie Janness and her dog in Piedmont Park, located about 1 mile northeast of downtown between the Midtown and Virginia Highland neighborhoods, has been joined by the Federal Bureau of Investigation, (FBI).

WXIA 11 Alive news reported that the FBI is assisting the Atlanta Police Department, (APD) however a spokesperson for the APD told WXIA the department wouldn’t provide any specifics about the FBI’s involvement with the investigation, nor did the Atlanta Field Office of the FBI comment. 

The Georgia Voice, the local LGBTQ newspaper, reported that Janness, a member of Atlanta’s LGBTQ community and a bartender at the LGBTQ-owned Campagnolo, was found stabbed to death in the park on Wednesday (July 28) after walking her dog Bowie, who was also killed.

Janness was found by her partner of six years, Emma Clark, after Clark tracked her with her phone’s GPS.

“Today, I lost the love of my life and baby boy,” Clark said in a post shared to a GoFundMe page. “It was tragic. She was the most intelligent, kind, humble, and beautiful person I have ever known. I wanted to spend every second with her. [Bowie] was the sweetest, most loyal companion. My heart is so very broken, my world will never be the same.”

A vigil was held for Janness on Thursday evening at Piedmont Park.

Atlanta Police continue to search for the suspect in a deadly stabbing of a woman in Piedmont Park

The Atlanta Journal-Constitution reported that Janness’ murder is believed to be the first homicide inside the park in 12 years and according to family members of Janness’ longtime girlfriend, a security camera at an intersection near the park’s entrance captured the last known picture of Katherine Janness and her dog before the two were killed.

But other cameras in the area weren’t working, including one facing the entrance. As of Friday the AJC also reported, as of Friday afternoon, Atlanta police had released few details about the murder investigation that has left city residents and parkgoers on edge.

Atlanta Police are asking that anyone with information to please come forward, and tipsters can remain anonymous by contacting Crime Stoppers Atlanta at 404-577-8477, texting information to 274637 or visiting the Crime Stoppers website.

APD detectives are also asking those who live in this area to review footage from their security cameras and contact the police if they find anything that may be pertinent to this investigation. The timeframe for review should be between 10:30 p.m. on Tuesday to 1:30 a.m. on Wednesday.

Continue Reading
Advertisement
Advertisement

Follow Us @washblade

Sign Up for Blade eBlasts

Popular