If the experiment with isoniazid works as anticipated, it will provide rich data that show exactly how this well-established drug works against the BCG strain, M. bovis. Then Kublin and his team will be a step closer to using this ethically acceptable stand-in for M. tuberculosis to evaluate, in similar trials, new generations of drugs or vaccines against dangerous human TB.
“Ultimately, this is a stepping stone to establishing a human challenge model for TB, using BCG as a proxy,” Kublin said.
To recruit participants in the trial, Kublin’s team relied on a registry of more than 2,000 Seattle area residents who signed up to show their willingness to volunteer. The Seattle MCTC Registry was originally built to recruit participants for malaria studies but was expanded to reach participants in trials looking at other diseases, said Gift Nwanne, MPH, who is study coordinator for the tuberculosis trial.
Nwanne brings to these trials his own personal experiences with malaria. Growing up in Kaduna, a state in northwestern Nigeria, he had multiple bouts of the mosquito-borne illness. His interest in health care brought him to work in clinics were people were treated for a different threat, TB.
“I have had colleagues infected with TB. I also worked in HIV, and TB is a leading cause of mortality for people with HIV/AIDS,” he said. “BCG is the only vaccine for TB. We should have multiple vaccines for it.”
A microbiologist becomes a research study volunteer
Seattle resident Susan Strenk, MPH, is a microbiologist at Fred Hutch and was also a participant in Kublin’s malaria study before she volunteered for the tuberculosis trial. In the lab of David Fredricks, MD, she explores microbial communities — the microbiome — developing an understanding of clinical studies from a laboratory researcher’s perspective.
“I used to grow TB and other mycobacteria from patients in a clinical lab, when I worked at Harborview (Seattle’s public hospital),” Strenk said. “So, it is kind of cool to see the other side of it.”
Because of her experience in the malaria study, Strenk was already familiar with the discomfort of injections and blood draws, as well as the health risks sometimes involved. She said participating in studies helps her in her own work. By volunteering, she said she is gaining a better idea of the expectations, concerns and preferences of patients and other participants in clinical trials.
“You know what studies are like when you are conducting them, but you don’t know what it is like for the people who enroll in them,” Strenk said. “I feel like it gives me an inside look at things.”
Working in the field, and experiencing clinical trials as a participant, have eased any concerns she might have had about such experiences.
“I trust the doctors,” she said. “I know they are going to be watching me, and if something goes wrong, I’m not too worried, as I’ll get proper care.”
Collaborators in the BCG study include Chetan Seshadri, MD, and his colleagues at the University of Washington Department of Global Health; TB experts at the Cape Town HVTN Immunology Laboratory, in South Africa; and Julie McElrath, MD, PhD, senior vice president and director of the Vaccine and Infectious Disease Division and holder of the Joel D. Meyers Endowed Chair at Fred Hutch.