A PHASE II RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO STUDY THE SAFETY AND IMMUNOGENICITY OF V212 IN ADULT PATIENTS WITH AUTOIMMUNE DISEASE

Not Applicable

• Registration Number: PER-031-12
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. PATIENT IS ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING INFORMED CONSENT.
2. PATIENT HAS BEEN DIAGNOSED WITH AN AUTOIMMUNE DISEASE, INCLUDING BUT NOT LIMITED TO RA, PSA, PSO, IBD, SLE, MS, OR OTHER SIMILAR DISEASES (SEE APPENDIX 6.1). (NOTE: SLE PATIENT MUST FULFILL THE REVISED AMERICAN COLLEGE OF RHEUMATOLOGY CLASSIFICATION CRITERIA FOR DIAGNOSIS [SLE DIAGNOSIS CRITERIA PROVIDED IN APPENDIX 6.3]. MS PATIENT MUST FULFILL THE 2010 REVISIONS TO THE MCDONALD CRITERIA FOR DIAGNOSIS OF MS [MS DIAGNOSIS CRITERIA PROVIDED IN APPENDIX 6.4]).
3. PATIENT IS NOT LIKELY TO UNDERGO HET DURING THE STUDY PERIOD (THROUGH 28 DAYS POSTDOSE 4).
4. PATIENT MUST BE ON AT LEAST ONE BIOLOGIC AGENT, SUCH AS A TNF ALPHA INHIBITOR, OR A NON-BIOLOGIC THERAPY, AT A STABLE DOSE FOR ≥ 3 MONTHS, WITH NO PLANNED OR ANTICIPATED CHANGES IN TREATMENT REGIMEN AT THE TIME OF ENROLLMENT. TREATMENT ROUTE OF ADMINISTRATION MUST BE PARENTERAL OR ORAL; TOPICAL ADMINISTRATION ALONE IS NOT SUFFICIENT (SEE APPENDIX 6.2).
5. MINIMUM DOSES ARE REQUIRED FOR THE FOLLOWING TREATMENTS IF TAKEN AS MONOTHERAPY:

Exclusion Criteria

1. A HISTORY OF ALLERGIC REACTION TO ANY VACCINE COMPONENT (INELUDING GELATIN) OR AN ANAPHYLACTIC/ANAPHYLACTOID REACTION TO NEOMYCIN (A HISTORY OF CONTACT DERMATITIS TO NEOMYCIN IS NOT A CRITERION FOR STUDY EXCLUSION).
2. PRIOR HISTORY OF HZ WITHIN 1 YEAR OF ENROLLMENT.
3. PRIOR RECEIPT OF ANY VARICELLA OR ZOSTER VACCINE.
4. PATIENT HAS ACTIVE CENTRAL NERVOUS SYSTEM (CNS) LUPUS (INCLUDING SEIZURES, PSYCHOSIS, ORGANIC BRAIN SYNDROME, CEREBRITIS OR CNS VASCULITIS) REQUIRING THERAPEUTIC INTERVENTION WITHIN 90 DAYS OF ENROLLMENT.
5. PATIENT IS RECEIVING OR EXPECTED TO RECEIVE THERAPY CONTAINING RITUXIMAB OR ANY OTHER ANTI-CD20 MONOCLONAL ANTIBODIES AT ANY TIME DURING THE TIME PERIOD BEGINNING 3 MONTHS PRIOR TO ENROLLMENT THROUGH 28 DAYS POSTDOSE 4.
6. PATIENT IS RECEIVING SYSTEMIC CORTICOSTEROID THERAPY, PREDNISONE OR PREDNISONE EQUIVALENT > 40 MG/DAY AT THE TIME OF ENROLLMENT.
7. PATIENT HAS RECEIVED SYSTEMIC PREDNISONE OR PREDNISONE EQUIVALENT ≥ 50 MG/DAY FOR ≥ 30 DAYS WITHIN 6 MONTHS OF ENROLLMENT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified