Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents

Inclusion criteria

• ✓. Provide informed consent and assent as applicable prior to initiation of any trial procedures.
• ✓. Be able to understand and agrees to comply with planned trial procedures and be available for all trial visits.
• ✓. Agrees to the collection of venous blood per protocol.
• ✓. Healthy male or non-pregnant female between 12 and 55 years of age inclusive at time of enrollment who are not at high risk of SARS-CoV-2 exposure defined as individuals whose health status, profession, locations or circumstances put them at high risk of exposure to SARS-CoV-2 and COVID-19.
• ✓. Body Mass Index (BMI) \<40.0 kg/m2 (or \< 35.0 kg/m2 if obesity-related health conditions are present) at screening. Subjects must weigh a minimum of 31 kg.
• ✓. Women of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception.\*\*\*, \*\*\*\* Note: These criteria are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the criteria do not apply to subjects in a same sex relationship).
• ✓. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination.
• ✓. Male subjects of childbearing potential\*: use of condoms to ensure effective contraception with a female partner of childbearing potential from vaccination until 90 days after vaccination. If barrier methods are to be used, then double barrier methods of protection are required i.e. male condom with a cap, diaphragm or sponge with spermicide. \*Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy.

Exclusion criteria