Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older

Inclusion criteria

• ✓. Male and non-pregnant female participant must be ≥50 years of age inclusive, at the time of signing the informed consent.
• ✓. Participants who are healthy as determined by medical evaluation including comprehensive medical history, comprehensive physical examination, vital signs\*, and screening laboratory tests conducted no more than 30 days prior to first study injection administration (Day 0).
• ✓. (Applicable only for arms A through I) Completed an Emergency Use Authorization (EUA) or Conditional Marketing Authorization or licensed initial COVID-19 vaccine series (as applicable) ≥30 days prior to enrollment (i.e., at least 30 days prior to the Day 0 visit).
• ✓. Screening laboratory values \[sodium, potassium, blood urea nitrogen (BUN), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), total bilirubin, alkaline phosphatase, creatinine, random glucose, white blood cell count with differential, hemoglobin, and platelet count\] must be within normal ranges or considered not clinically significant by the PI.\*\*
• ✓. Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening. If HIV 1/2 antibody is positive, and confirmation testing is negative the participant may be enrolled.
• ✓. Normal urinalysis or, if abnormal, urinalysis determined to be not clinically significant by the PI at screening.\*\*
• ✓. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
• ✓. Capable of understanding and giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to any screening procedures.

Exclusion criteria