Human-Challenge Influenza Clinical Study Launched by NIAID
Study to assess how pre-existing influenza antibodies impact the timing, magnitude and duration of flu symptoms
A clinical trial in which healthy adults will be deliberately infected with the influenza virus is recruiting volunteers at 4 Vaccine and Treatment Evaluation Units (VTEUs).
This new study announced on October 23, 2019, builds on previous work by scientists in the National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Infectious Diseases to develop a model of influenza disease, with controlled human infection studies.
Study volunteers will receive a nasal spray containing a strain of seasonal influenza virus made under good manufacturing practice conditions. Preliminary trial results are expected in May 2020.
One aim of the study is to assess how levels of pre-existing influenza antibodies impact the timing, magnitude, and duration of a volunteer's flu symptoms, following exposure to the influenza virus.
Up to 80 people aged 18 to 50 years will be enrolled in the trial. The 1st doses of challenge virus were administered to 5 volunteers earlier in October 2019.
"NIAID investigators have been pioneers in contemporary human influenza challenge trials," said NIAID Director Anthony S. Fauci, M.D., in a press release. "These trials provide a powerful tool to study many aspects of influenza disease progression and also can help to efficiently assess new treatments and vaccine candidates."
Dr. Fauci added: "Expanding the capacity to perform human challenge trials is a key goal in NIAID's strategic plan to support the development of vaccines that confer broad and durable protection against influenza. This new trial at the VTEUs will help us achieve that goal."
The challenge virus, InfluenzaA/Bethesda/MM2/H1N1, was developed by NIAID scientists and reliably produces mild to moderate influenza disease in most recipients. It has been administered to approximately 400 participants in 4 previous influenza challenge trials conducted at the NIH Clinical Center in Bethesda, Md.
No significant safety issues or severe or complicated cases of influenza occurred, and no transmission of the virus outside of the clinic was seen during the earlier trials.
In the current trial, volunteers will remain in the clinic for at least 7 full days after being challenged with the virus. Blood samples and nasal and throat swabs will be taken before and periodically after the viral challenge to trace the initiation, size, and duration of various immune system responses, and to detect virus shedding.
The appearance and resolution of flu symptoms, such as fever and muscle aches and weakness, will be recorded daily by the volunteers and study staff for a total of 14 days after the virus challenge.
All volunteers will be followed for approximately 90 days post-challenge and will have additional blood and nasal wash samples taken at several follow-up clinic visits.
The lead VTEU site is the University of Maryland School of Medicine, Baltimore, where Kathleen Neuzil, M.D., is the principal investigator.
Other VTEUs conducting the trial, and lead investigators at each, are:
- Cincinnati Children's Hospital Medical Center (David Bernstein, M.D.)
- Duke University (Christopher Woods, M.D.)
- Saint Louis University Center for Vaccine Development (Daniel Hoft, M.D., Ph.D.)
Additional information about the trial, H1N1v Virus Challenge Study in Healthy Subjects, is available here.
NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.
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