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Since 1964, the Lindsley F. Kimball Research Institute (LFKRI) has conducted groundbreaking research, resulting in numerous landmark patents and licenses as well as new blood-related products, techniques, and therapies. Today, LFKRI remains at the forefront of blood research by leveraging the resources of New York Blood Center Enterprises (NYBCe) to further our understanding of blood diseases and improve patient outcomes.

LFKRI currently consists of 20 pioneering investigators studying transfusion epidemiology, blood component therapeutics, transfusion-transmitted infectious disease, and transfusion immunology. One such investigator is Hong Van Tieu, MD, MS.

In addition to being an Associate Member of LFKRI, Dr. Tieu is also the Head of the Laboratory of Infectious Disease Prevention. Dr. Tieu recently sat down with NYBCe representatives to help others learn more about her work and how it advances the organization’s lifesaving mission.

Q: How long have you been with the Enterprise?

Dr. Tieu: I’ve worked at NYBCe and LFKRI since 2008!

Q: Which areas of research have you primarily focused on during that time?

Dr. Tieu: I’m currently Head of the Laboratory of Infectious Disease Prevention, also known as Project ACHIEVE in the community, so I’ve been involved in infectious disease epidemiology and prevention research.

The Lab is part of the largest clinical trials program (the National Institutes of Health (NIH) /National Institute of Allergy and Infectious Diseases (NIAID)-funded HIV Vaccine Trials Network (HVTN)) devoted to the development and testing of preventive HIV vaccines worldwide. We use epidemiology to stay up to date on who is at risk for HIV and why. We design and test innovative prevention strategies to increase HIV testing and pre-exposure prophylaxis (PrEP) uptake and reduce risk. We also conduct community engagement to support our research studies.

We’re also now part of the clinical trials program devoted to the development and testing of SARS-CoV-2 vaccines. In collaboration with the NIH/NIAID-funded COVID-19 Prevention Trials Network (CoVPN), our research involves implementation of multiple Phase 3 SARS-CoV-2 clinical research trials to test the safety, tolerability, and efficacy of vaccines to prevent COVID-19.

I’ve been involved in a variety of other projects, too.

Q: Let’s talk about Project ACHIEVE’s work on HIV prevention and treatment. Where does this research currently stand? Are there any recent milestones you and your team have reached that you’d like people to know about?

Dr. Tieu: To give you some background, the Laboratory of Infectious Disease Prevention and Project ACHIEVE were established in 1993 under the leadership of Dr. Beryl Koblin. The Lab initially focused on HIV epidemiology before moving into HIV vaccine preparedness, seeing if people in New York City were willing to participate in clinical HIV vaccine trials. Then, Dr. Koblin applied to be part of the National Institute of Health’s HIV Vaccine Trials Network, and Project ACHIEVE became one of their North American sites.

The HIV Trials Network also enabled the Lab to join a variety of HIV vaccine clinical trials as well as other clinical trials involving biomedical and behavioral interventions to prevent HIV in the general population as well as specific at-risk populations, such as men who have sex with men, transgender individuals, and gender non-conforming individuals in the LGBTQIA+ community.

To stay in the HIV Vaccine Trials Network, we recompete as a clinical research site every seven years. We were successful again last year and continue to be part of the clinical trials unit that’s based at Columbia University Irving Medical Center, the Columbia Collaborative HIV/AIDS Clinical Trials Unit. We work collaboratively to advance clinical research in HIV vaccines and other biomedical prevention strategies and are currently working on several exciting studies.

One is a large, late stage Phase 3 trial looking at the efficacy of an HIV vaccine regimen. We were also involved in the earlier stages of the trials, looking at safety, tolerability, and immune responses of the HIV vaccines. Now, we’re actively enrolling participants into the Phase 3 study to test whether these vaccines are effective at preventing HIV in those who are at risk for getting HIV. The multinational trial is looking to enroll 3,800 participants globally, and enrollment will likely finish in September 2021. The study then continues for 30 months. It’s all very exciting because there have been very few Phase 3 HIV vaccine trials to date, and we are eagerly anticipating the results of this trial as we urgently need an HIV vaccine to stop the epidemic.

We’re also continuing to do work on several Phase 1 HIV vaccine trials involving vaccine candidates that are being tested in humans either for the first time or that are still in the early stages of determining safety, tolerability, and immune responses in generally healthy adults who are not at risk for getting the HIV infection.

One of these Phase 1 trials is actually investigating mRNA technology — the same technology currently being used in the Pfizer and Moderna COVID-19 vaccine trials.

Q: That’s all very exciting. Can you speak to any of the short- or long-term implications that you think that this research may have?

Dr. Tieu: Absolutely. We’ve made a lot of progress in HIV research over the last 40 years, especially on the HIV treatment side. More recently, there have also been advances in HIV prevention, specifically in pre-exposure prophylaxis (or PrEP) through medications like oral Truvada for HIV prevention. Truvada was approved by the US FDA in 2012 to prevent HIV infection among men who have sex with men as well as in women.

One of the issues with taking oral Truvada is adherence. You have to take it daily, at least among cisgender women, and at least 4 times per week in men, for it to be effective in preventing HIV. So, more recently, there have been studies looking at long-acting injectable medications that are administered every two months to prevent HIV to overcome the adherence issues of an oral drug that needs to be taken every day.

A few years ago, we were involved in the early phase study for an injectable HIV drug called cabotegravir. Cabotegravir has a long half-life and is injected intramuscularly every two months. The research study we were involved in found that it was safe and well tolerated. Injectable cabotegravir then moved on to a Phase 2b/3 late stage trial, called HPTN 083, to test whether it is effective in preventing HIV compared to oral Truvada. We are a site in this HPTN 083 trial!  The study found that injectable cabotegravir is better than daily oral Truvada in preventing HIV, although both drugs have high rates of protection overall. The sponsor is planning on submitting injectable cabotegravir as PrEP for FDA review and approval later this year. If it is approved as a pre-exposure prophylaxis for HIV in both men and women, that would be a great achievement on our end.

Q: Pivoting for a minute, can you speak more about the Laboratory of Infectious Disease Prevention’s work with COVID-19 vaccines and monoclonal antibodies?

Dr. Tieu: We’ve been part of the National Institute of Health and the National Institute of Allergy and Infectious Diseases’ HIV Vaccine Trials Network for years, so we have vast experience conducting clinical vaccine trials and also with recruitment and community engagement. So, when New York City became the epicenter of the COVID-19 pandemic in March 2020 and the pandemic spread to other parts of the U.S., we were invited to become involved in the COVID-19 Prevention Network (CoVPN). Of course, we enthusiastically joined.

As a site, we became involved in the Phase 3 AstraZeneca COVID-19 vaccine trial as well as the Phase 3 Johnson & Johnson vaccine trial. We enrolled 250 participants total in the two trials. Based on our experience with HIV vaccine trials, we knew it was very important to recruit and enroll participants of diverse race/ethnicity and socioeconomic status, especially considering how the COVID-19 pandemic disproportionately affected minority and poor individuals in the city and there have been historically low representation of these groups in clinical trials.

The CoVPN provided us with a mobile van that was staffed with personnel from Matrix Medical Network who were experienced with mobile clinics. We stationed the van in two key neighborhoods, one in Jackson Heights, Queens and the other in Flatbush, Brooklyn, five days a week. Later, we also opened a satellite site in Chelsea in lower Manhattan. We purposely chose these neighborhoods, in addition to doing research at our main site in the New York Blood Center building on East 67th Street in Manhattan, to ensure we are able to do community outreach and recruit racially/ethnically diverse people into our studies.

Our experience in HIV vaccine research really provided us with the expertise needed to successfully recruit and enroll participants in these COVID-19 vaccine trials. Both HIV and COVID-19 are associated with stigma, so we were able to conduct community forums to address these barriers and to do in-person outreach and speak directly to people walking on the streets outside our mobile van. And we were successful!

Across the two Phase 3 COVID-19 vaccine trials, over half of the participants we enrolled self-identify as nonwhite. This achievement is key to helping communities that continue to be disproportionately impacted by the pandemic.

Q: Last question: what’s the main thing you want readers to walk away with? How can the general public support this lifesaving research?

Dr. Tieu: We’re involved in many important studies — ones we haven’t even touched on in this conversation. For example, we’re involved in social-epidemiological studies looking at how neighborhoods and social networks influence HIV care outcomes, a study looking at whether COVID-19 vaccination reduces the spread of SARS CoV-2 virus infection among young adults, and more. I encourage everyone to visit our website and, if you’re interested, please consider screening for one of our studies. We also have an active community advisory board (CAB) composed of members who advise us on our studies, so we welcome anyone who is interested in becoming part of our CAB.

If you’d like to support Dr. Tieu and the Laboratory of Infectious Disease Prevention’s research on HIV and COVID-19, please consider giving online now. You can also contact the Office of Philanthropy directly to learn more about NYBCe’s philanthropic needs and download the 2021 Community Impact Statement to learn more about the direct humanitarian benefits of this groundbreaking blood research.