COVID-19 Raises the Stakes of Preventive Medicine in Oncology

Anna Giuliano, PhD

The coronavirus disease 2019 (COVID-19) has the potential to erode vaccine and treatment trust, explained Anna Giuliano, PhD, who added that the work researchers are doing to build resiliencies back into vaccine programs and develop simpler therapeutics for virus-related cancers has become more essential than ever.

“Our goal is ultimately eliminating all of these cancers with primary prevention with vaccine. The second part is to prevent deaths due to those cancers with simple interventions,” said Giuliano. “[However], we’re fighting a lot of different actors that want to get in the way of good science and good application of science to policy. There have been a lot of challenges."​

In an interview with OncLive, Giuliano, founding director of the Center for Immunization and Infection Research in Cancer and senior member at Moffitt Cancer Center, discussed the work efforts to advance the reach of preventive vaccines for cancers, and the challenges researchers are facing in the process.

OncLive: Could you describe the research you’re involved in at Moffitt Cancer Center?

Giuliano: I direct the Center for Immunization and Infection Research in Cancer. Our center conducts research, both to understand the infections that cause cancer, so the classic cancer epidemiology studies and then molecular studies as well, as well as interventions to prevent and treat those cancers. For instance, in our portfolio are studies focused on screening for hepatitis C virus so we can get people on the continuity of care for treatment to prevent liver cancer. We have faculty that are focused on Epstein Barr virus infection, while others are focused on treatment outcomes among people living with HIV.

My personal research is focused on the prevention and treatment of human papillomavirus [HPV]-related cancers. We have several different clinical trials that are ongoing for the prevention of HPV cancers in men and women, as well as developing protocols for therapeutics for HPV-related cancers.

How has the stigma surrounding vaccines affected the work that has been done with them?

One of the things we battle all the time is a lack of vaccine confidence. I’m very concerned about what’s happening with the discussions about safety of any COVID-19 vaccine that may come down the line and how that influences how people think about the standard vaccines that have undergone years and years of testing in multiple populations. This is something we’re constantly battling.

I like to talk about building resiliencies back in vaccine programs. COVID-19 has given an amazing example of how vaccine programs can break down. This is not a vaccine confidence issue. This is a simple issue of people who haven’t been going to their providers. When you look at the vaccine uptake in children—standard pediatric vaccines, as well as HPV vaccine—it has plummeted in the last 6 months. Many of us are really concerned about how we’re going to recover that to maintain a high level of vaccine coverage, so we don’t see measles. If we have a breakdown in the traditional vaccines, while our children aren’t having severe symptoms with SARS-CoV-2, they will have severe symptoms with measles. This will have tremendous ramifications for a lot of different diseases.

With the HPV vaccine, one of the things I’ve been very active in promoting mainly as an outcome of the research that we’ve done here is gender neutral vaccination and the importance of including males in those programs. In the United States, we have not reached our goal of 80% gender neutral vaccination. In the state of Florida in the southeast region, we’re doing particularly bad. We have partnered with [key stakeholders] and the community outreach, engagement and equity group to start launching a series of different more practical programmatic activities, working with community health centers, and other organizations that deliver vaccines.

Could you elaborate on some of the ongoing clinical trials for patients with HPV-related cancers?

In terms of treatment trust, we’re currently conducting 2 phase 3 trials. One is an international phase 3 trial that is evaluating whether the vaccine will prevent persistent oral HPV infections, which is the obligate precursor to oropharyngeal cancer. The FDA did a provisional licensure of the vaccine for the prevention of oropharyngeal cancer only a couple of months ago in June. That is a provisional indication that is dependent on the completion of this phase 3 trial, demonstrating true efficacy. So, this is a really important trial.

We worked very closely with Merck to design that trial, and it’s a long, really fun, story of how we were going to have it in the public domain. No one ever thought that the FDA would accept some of the end points; they did. It was transferred over to Merck to run as a licensure trial. We had originally included people living with HIV in that trial. Merck made the decision to only include those who are negative. Therefore, we’re conducting another phase 3 trial, with National Cancer Institute funding, in Latin America in men who are living with HIV to see if we can demonstrate efficacy of the vaccine to prevent those cancers in men with HIV.

Treatment is a different story for us. Right now, most of our effort is in coming up with novel, low-cost low-technology methods to treat patients with early cervical cancer and precancer. Our goal is a 30% reduction in mortality due to cervical cancer worldwide. That mortality is happening in the poorest countries among the poorest women. With the treatments we currently have, [that goal] isn’t going to happen. We’re not going to reach that goal. We have to come up with simpler therapeutics. We have a consortium of practitioners and, my most important partner and immunologist, is a co-director of the center with me, Shari Pilon-Thomas, PhD. We’re working with several different companies that have therapeutic vaccines in their pipeline. We have one scheduled to go into a phase 1 trial, probably in 2022, in Latin America. We’re working on another approach that we hope to be able to do a phase 1 to [establish] safety and feasibility at the end of next year, and that would be here in Florida and other sites in the United States.