Biopharmaceutical company AstraZeneca chose the IU School of Medicine to participate in a late-stage clinical trial in partnership with Oxford University, testing a vaccine known as AZD1222. The Phase III clinical trial, a part of the U.S. Health and Human Services Operation Warp Speed, is the last required stage before the potential vaccine can be approved by the Food and Drug Administration for widespread public use.
Overall, the trial aims to enroll 30,000 participants at 80 different sites around the United States. The IU School of Medicine site, housed within the Clinical Research Center at IU Health University Hospital, is the only site in Indiana for the study.
This extraordinary opportunity to advance testing of the vaccine candidate is led by Cynthia Brown, an associate professor of clinical medicine at the IU School of Medicine.
Within minutes of the trial being announced, more than 3,000 Hoosiers signed up to participate through All IN for Health, a program made possible by the Indiana Clinical and Translational Sciences Institute that is dedicated to improving the health of Indiana residents by promoting health resources and research and clinical study opportunities. Recognizing the importance of including participants from many backgrounds to determine the best preventative treatment, the Indiana team will connect with minority groups to encourage participation in this important study, as it tests the potential of a vaccine for the people of Indiana and the world.
Leveraging three decades of ongoing work studying rotavirus, a very common childhood illness, IU researchers pivoted to focus this expertise on developing a vaccine that will protect children against COVID-19.
The goal is to reengineer rotavirus to make virus strains that also produce the coronavirus spike protein, so when a child is immunized with rotavirus vaccine, they may also be protected from COVID-19.
So far, Asha Philip, a graduate student in the John Patton laboratory, has generated several recombinant rotaviruses that grow well, are stable, and are very efficient in expressing the spike protein, all valuable qualities in developing potential vaccine candidates. The Patton lab team has also discovered the recombinant rotaviruses can be expected to induce immune responses in vaccinated individuals that will help protect them against SARS-CoV-2 infections. Another lab member, Chantal Agbemabiese, is helping to modify the viruses into strains appropriate for use in infants and young children. The team is assessing the effectiveness of the strains to determine which are best suited as vaccine candidates.
A vaccine for children is critical, because children can be asymptomatic carriers spreading COVID-19 disease throughout families and communities. Patton and his team are working tirelessly to make sure those children can receive a vaccine that is safe and effective in reducing the severity of their disease and the pandemic's spread.
John Patton is an associate professor of biology and Blatt Chair of virology in the College of Arts and Sciences at IU Bloomington.
Samir Gupta, of IU's School of Medicine, joined researchers all over the world to study the effects of remdesivir on patients with COVID-19. Gupta, a professor of medicine in the Division of Infectious Diseases, is leading two separate studies regarding the use of remdesivir to determine the optimal length of treatment for COVID-19 patients.
Gupta and his team are making "positive strides," Gupta says, in determining how to properly treat patients with COVID-19.
The worldwide trial, involving hundreds of sites internationally, is being led by Gilead Sciences, the biopharmaceutical company that developed remdesivir.
Description of the video:
[Music plays]
[IU Trident and words Indiana University School of Medicine appear on screen]
[Seated professor wearing glasses appears on screen. Words SAMIR GUPTA, Professor of Medicine, appear at bottom of screen]
I’m Samir Gupta. I’m a professor of medicine in the division of infectious diseases at the IU School of Medicine and I also serve as the vice chair for research.
[Empty laboratory vials appear on screen.]
We’re making positive strides, so I really do believe
[Laboratory worker wearing blue scrubs and gloves picks up box of vials]
that by the end of this calendar year, we’ll have a much firmer handle on how to properly treat patients with COVID-19
[Empty glass vials move on a conveyor belt]
and maybe also be able to determine what types of treatment would be better suited,
[Machine automatically fills vials]
based on individual patient characteristics.
We were testing the use of remdesivir at two different durations of treatment, at five or ten days,
[Vials capped with black lids move on conveyor belt]
in patients who were hospitalized but didn’t require extra oxygen. The second trial
[Samir Gupta reappears on screen, talking]
was very similar to primary trial run by the NIH that compared remdesivir with placebo in severely ill patients,
[Vials with black lids and silver labels move on conveyor belt]
but in this trial, severely ill patients through the IU Health system, defined as requiring extra oxygen or being on a mechanical ventilator,
[Vials with black lids and silver labels move around circles on conveyor belt]
the trial was determining if five or ten days of treatment was preferable in terms of helping the patient recover, as well as eliminating side effects. Doing these proper randomized trials will give us
[Laboratory worker wearing hazmat suit and blue goggles appears on screen]
really good evidence if a therapy, in this case, remdesivir
[Image of laboratory appears on screen]
is truly helpful and also gives us a fair assessment of the
[Different image of lab and laboratory worker appears on screen]
side effects of the drug, compared to not receiving it.
[Image of empty vials upside down on conveyor belt and being sprayed with water appears on screen]
So if the entire trial was done just here in Indianapolis, well then that's great,
[Empty glass vials move on a conveyor belt]
it would answer questions about people with COVID-19 here in Indiana,
but it may not pertain to patients in Europe, in Asia, in South America,
[Video pans up from vials on conveyor belt to show laboratory worker in hazmat suit and blue goggles working in lab]
because there are differences in environment, in genetics,
[laboratory worker in hazmat suit and blue goggles working in lab]
in local customs of how to treat infectious diseases. So, in a worldwide trial,
[Machine automatically fills vials]
if we still see a positive, beneficial signal or result with remdesivir, that really means something.
[Laboratory worker wearing white lab coat, safety glasses, gloves, and blue head covering enters lab carrying stack of boxes]
That means that we can use this treatment anywhere in the world
[Two lab workers work in lab]
and should get similarly-good results.
[Lab worker with beard wearing blue head covering and lab coat works with another lab colleague and watches as blue capped vials come off of conveyor belt into boxes.]
The next phase of the developmental program here is to determine if perhaps combination therapies will be even more effective than just giving remdesivir alone.
[Blue capped vials automatically fill boxes]
I’m just so proud of our team and it’s a testament to the single-minded mission the whole school and the university has had
[Samir Gupta reappears on screen, talking]
over these last three months to help everybody deal with this pandemic.
[IU trident and words Indiana University School of Medicine appear on screen. Screen fades to black]
[Music ends]
