H1N1v Virus Challenge Study in Healthy Subjects

Inclusion criteria

• ✓. Provide written informed consent prior to initiation of any study procedure.
• ✓. Are able to understand and comply with planned study procedures and be available for all study visits.
• ✓. Agree to remain an inpatient for at least seven days after challenge, and until they have no virus shedding,\* determined by qualitative RT-PCR for a minimum of two consecutive days post-challenge.
• ✓. Healthy\* males and non-pregnant, non-breastfeeding females\*\*, aged \>/= 18 and \</=49 years of age, inclusive, at enrollment.
• ✓. Women of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least 1 acceptable primary form of contraception\*\*\*,\*\*\*\*.
• ✓. Non-habitual smoker\* of tobacco, e-cigarettes or marijuana.
• ✓. No self-reported or known history of alcoholism or drug use within the last 30 days and agrees to abstain from alcohol and drugs\* for at least one week before admission and throughout the inpatient period.
• ✓. Negative drug urine toxicology result on screening (i.e., amphetamines, cocaine, and opiates) and on admission to the challenge unit (i.e., amphetamines, cocaine, opiates, and cannabinoids).

Exclusion criteria