Shingles Prevention Study (SPS)
Herpes Zoster, Postherpetic Neuralgia
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring varicella-zoster vaccine
Eligibility Criteria
Inclusion Criteria: Adults 60 years of age and older. History of Chickenpox. Have given written informed consent prior to enrollment. History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA. Exclusion Criteria: No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy). No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid [greater than 800 mcg/day beclomethasone dipropionate or equivalent]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation). No active neoplastic disease (except local skin cancer or other malignancies [e.g., prostate cancer] that are stable in the absence of immunosuppressive/cytotoxic therapy). No prior Herpes Zoster. No prior receipt of varicella vaccine. No allergic sensitivity to neomycin. No history of anaphylactoid reaction to gelatin. No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years). Not ambulatory (must not be bed-ridden or homebound). No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period. No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products [e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]), or scheduled within 6 weeks after study vaccination. Not currently receiving antiviral therapy. No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study. No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study. No females who are pre-menopausal. No subjects unlikely to adhere to protocol follow-up. No subjects involved in a conflicting (vaccine or investigational drug) clinical trial.
Sites / Locations
- VA Medical Center, Birmingham
- VA Palo Alto Health Care System
- VA San Diego Healthcare System, San Diego
- University of Colorado
- James A. Haley Veterans Hospital, Tampa
- Edward Hines, Jr. VA Hospital
- VA Medical Center, Lexington
- VA Maryland Health Care System, Baltimore
- NIH-NIAID (Bethesda, MD)
- VA Medical Center, Jamaica Plain Campus
- VA Ann Arbor Healthcare System
- VA Medical Center, Minneapolis
- VA Medical Center, St Louis
- New Mexico VA Health Care System, Albuquerque
- New York Harbor HCS
- VA Medical Center, Northport
- Rochester, NY (NIH)
- VA Medical Center, Durham
- Vanderbilt University
- Baylor University
- University of Texas at San Antonio
- VA Puget Sound Health Care System, Seattle
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1
Arm 2
varicella-zoster vaccine
vaccine placebo