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

Exclusion criteria

• . History of herpes zoster (shingles).
• . History or presence of acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, gastrointestinal, endocrinologic or renal disorders, or uncontrolled hypertension) which in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
• . History of autoimmune disease or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders) that is likely to affect the immune response to vaccination as determined by the PI.
• . Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
• . Abnormal blood pressure \>150 mm Hg systolic or \>95 mm Hg diastolic prior to first study injection administration (Day 0).\*\*\*
• . History of significant psychiatric illness (including history of suicidal ideation or attempt) with or without current medication.
• . BMI ≥40kg/m2 at screening (where BMI \>34.9 kg/m2, clinically-significant abnormal serum glucose at screening determined by the PI, or clinically-significant diseases or medical conditions, as determined by the PI, is exclusionary.)
• . Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 4 years).