A clinical trial in which healthy adults will be deliberately infected with influenza virus under carefully controlled conditions is recruiting volunteers at four Vaccine and Treatment Evaluation Units (VTEUs) supported by the National Institute of Allergy and Infectious Diseases (NIAID). One study aim 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 influenza virus. NIAID is part of the National Institutes of Health.
The first doses of challenge virus were administered to five volunteers earlier this week. Up to 80 people aged 18 to 50 years will be enrolled in the trial. The study builds on recent work by scientists in the NIAID Laboratory of Infectious Diseases to develop a model of influenza disease with controlled human infection studies.
Volunteers will receive a nasal spray containing a strain of seasonal influenza virus made under good manufacturing practice conditions. 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 four previous influenza challenge trials conducted at the NIH Clinical Center in Bethesda, Maryland. 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.
Preliminary trial results are expected in May 2020.
