Methods: hVIVO recruited 20 mild atopic asthmatics with low serum neutralizing antibodies. Subjects had full health screens including physical examinations, pulmonary function, and skin prick tests. Subjects were brought to quarantine a day before inoculation and randomized to either a 10TCID50 dose of virus (n=13) or placebo (n=7). Throughout the controlled quarantine period, regular timed samples were taken and assessments performed for 8 days, before discharge. Asthmatic data were compared to data obtained from healthy subjects given the same dose of virus.
Results: Of the 13 asthmatics inoculated with virus, 11 (85%) were infected (confirmed by PCR), 4 of the infected (36%) exacerbated (ACQ score rise by 0.5), and had measurable reductions in PEF. Interestingly the infected asthmatics had a more rapid onset of both upper and lower respiratory symptoms, preceding healthy subjects.
Conclusions: A GMP HRV-16 strain of virus has safely progressed through the 1st two stages of characterization in volunteers. Mild asthmatics exacerbated upon inoculation with a low dose of HRV, had reductions in lung function and a rapid onset of symptoms. Robust assessments and sampling within quarantines can aid in reducing noise and could allow for more precise and dynamic measurement of drug efficacy.