HIV vaccine clinical trials get a boost from COVID-19 successes

Oracle’s healthcare innovation group is working with HIV researchers to recruit vaccine clinical trial participants.

When the scientific and medical world pivoted to focus on treatments and vaccines for COVID-19, doctors at Seattle-based Fred Hutchinson Cancer Research Center had a head start.

Dr. Jim Kublin, Principal Staff Scientist for the Vaccine and Infectious Disease Division and Executive Director for the HIV Vaccine Trials Network (HVTN) at Fred Hutch, had been working on several vaccine candidates for HIV. “Much of the success of the COVID vaccines was on the shoulders of HIV vaccine research over the past 20 years,” says Kublin. “The COVID vaccines showed the world that mRNA vaccines worked, and now we have mRNA HIV vaccine candidates.”

The success of the COVID-19 mRNA vaccines was due in part to the willingness of people to volunteer for vaccine trials. More than 700,000 people are part of the COVID-19 vaccine registry, collected through the CoVPN Volunteer Screening Registry. CoVPN was developed by Oracle in a matter of weeks and benefited from the level of citizen engagement engendered by the COVID-19 pandemic. “Two years later, we’ve demonstrated a tremendous success in the collaborative effort that we engaged in with Oracle,” says Kublin. “It was a no brainer for us to ask to do this for HIV as well.”

A new kind of clinical trial

But finding an AIDS vaccine has been a daunting scientific challenge, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to President Biden. Although in the United States, unlike some developing countries, many people consider it a chronic but manageable condition, it’s still a huge risk and burden for people who are living with it. More than 1.2 million people live with HIV in the US and there are more than 35,000 new infections each year, according to the Centers for Disease Control and Prevention. “It’s a challenge for us in the US because for the most part people in the US no longer know someone who has died of HIV,” says Kublin. “And it's harder to identify and enroll the more affected populations because oftentimes they are disenfranchised or vulnerable in some way.”

For Rebecca Laborde, senior director for the Oracle Healthcare Innovation team, it’s not just about finding the right number of people for a clinical trial. “It’s about finding the right number of the right combination of people, people who have the highest risk and would benefit the most.”

Laborde’s team answered the call, eager to refine the vaccine registry software that had been created under extreme pressure at the start of the pandemic. “It’s a new system, not just an update of the CoVPN,” says Laborde. “We were able to meet with clinical sites to understand how to improve their experience with CoVPN and better understand their workflows and stakeholder needs.”

The new vaccine registry system was built specifically for HIV, and it’s more flexible, allowing communication between trial participants and trial managers. Researchers at Fred Hutch can send out surveys and questionnaires, and participants can inform researchers about changes in their status or adverse events. The new registry software was built with the Oracle APEX low-code development platform, running on Oracle Autonomous Database, and uses Oracle’s Eloqua, a cloud-based marketing automation program, to create the two-way communication stream. Ultimately, Kublin hopes to enroll 7,000 participants in the HIV registry in the first year. “A level of success would be more rapid enrollment into our phase one clinical trials, more rapid progression from phase one to phase three, and ultimately more rapid development of a globally effective vaccine,” says Kublin.

We hear about vaccine hesitancy, but that sometimes overshadows the overwhelming majority of Americans who have been willing to get vaccinated. Additionally, participating in clinical trials has been seen as a way to step up and be of service to public health.

Dr. Jim Kublin Principal Staff Scientist for the Vaccine and Infectious Disease Division and Executive Director for HVTN, Fred Hutchinson Cancer Research Center

Beyond COVID-19 and HIV

In addition to working on an HIV vaccine, Kublin’s team is also researching tuberculosis and malaria. There are three mRNA vaccines currently being tested in the HVTN, and he expects to start many more in the next year.

“We hear about vaccine hesitancy, but that sometimes overshadows the overwhelming majority of Americans who have been willing to get vaccinated,” says Kublin. “Additionally, participating in clinical trials has been seen as a way to step up and be of service to public health.”

Ultimately, both Kublin and Laborde envision vaccine registries as a way to let people know about any clinical trial that might be available to them and allow researchers to follow up with people even after a clinical trial has concluded.

“We all banded together as a society and we came up with solutions to fix this problem,” says Laborde. “The fact that we're sitting here two years later with all of this progress and vaccines…it's not perfect, but we're in much better shape.”

Illustration: Kateryna Kon/Getty Images

Photography: Fred Hutchinson Cancer Research Center

View more Oracle Connect articles