RESEARCH SUPPORT. Millions of children suffer from ETEC diarrhea each year. Researchers from Sahlgrenska Academy have now developed a drinkable vaccine and a phase 3 study will soon begin. Gothia Forum and the Clinical Trial Center (CTC) have participated in all phases. “I’ve never been part of anything like this. The quality is incredible, and it’s really fun to work when things function like this,” says Anna Lundgren, docent of immunology at the Department of Microbiology and Immunology at the University of Gothenburg, on the role of Gothia Forum in the study.
Extensive development efforts are behind the study for an ETEC vaccine. The study has been underway for over 30 years and was initiated by Ann-Mari Svennerholm, a post-retirement researcher at the University of Gothenburg. The goal is to develop a drinkable vaccine for Enterotoxigenic Escherichia coli, also known as ETEC.
The project was restarted in 2010, as more people took interest in this bacterial illness. Bill Gates announced funding from the Gates Foundation to invest in severe diseases that are problematic for impoverished parts of the world. The research team at the University of Gothenburg received money at the time and a chance to start anew.
Children under five
A phase 2B trial is currently underway in Gambia, where the vaccine is being tested on kids, and plans are underway for a phase 3 trial in Zambia. This will determine whether or not the vaccine protects against ETEC.
“Our primary goal is to help children in low- and middle-income countries who could die of this diarrhea-causing disease,” says Anna Lundgren. “The kids who get this disease end up with repeated infections and also become more sensitive to other diseases, such as malaria. Their mental development can also be hampered by undernourishment caused by repeated bouts of diarrhea. The vaccine will hopefully also be able to be used by travelers visiting countries where ETEC is common. The benefit of a vaccine against ETEC is also that it reduces the use of antibiotics and thus combats antibiotic resistance, which is a global public health problem.”
A flexible organization
When Anna Lundgren and her colleagues were going to begin the first ETEC vaccine trial, the idea was to do it themselves under the auspices of the University. But then she began thinking of a sign she had seen in a hallway at the hospital: CTC, the Clinical Trial Center. She spoke with colleagues on the research team and they decided to find out how CTC could help. Anna was hoping for a bit of guidance along the way, but after the first meeting, she realized that CTC had a range of resources. The first trial was carried out at the University with the help of staff from CTC and Gothia Forum.
“It was really meaningful that we realized in time that we needed help. Monitoring was incredibly important to us in the beginning; we learned GCP and how to document,” says Anna.
After the first trial at the University, they moved the next study to CTC at Sahlgrenska University Hospital.
“CTC has helped us with everything from training and documentation to preparing vaccines. Dan Curiac, senior physician at CTC, has been in charge of the medical components of the studies. A large team of nurses and assistant nurses at CTC have worked with recruiting research staff, vaccine preparation, and taking samples. Doing this through the hospital and with the experience of the CTC, such as when side effects occur or other medical questions, has provided me and my colleagues at the University with a great sense of security,” says Anna.
“I don’t think it’s possible for academic researchers today to manage everything themselves in clinical trials. It is thanks to Gothia Forum and the CTC staff that we’ve been able to do this. These have been large studies and there have been intense periods. The level of commitment has been incredible, and we’ve been able to address the majority of requests.”
Industry, the medical care system, and academia
The study is an example of collaboration among academia, industry and the medical care system.
“Gothia Forum is behind the practical, medical, regulatory aspects; they get everything done perfectly. I’m responsible for the academic aspects; in terms of research, I know how to take samples, analyze them, and how to interpret the results. Since the beginning of the project, the company has contributed to development and has been in charge of the production of all vaccine components. The company is now a sponsor for the latter phases and is in charge of the long-term effort to achieve approval for the medication. I think all three parties need to be involved in the development of a drug in order for the process to work.”
BY: ZANDRA FLORIN / GOTHIA FORUM
