A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER CLINICAL TRIAL TO STUDY THE SAFETY, TOLERABILITY, EFFICACY, AND IMMUNOGENICITY OF V212 IN RECIPIENTS OF AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTS (HCT)

Not Applicable

• Conditions: -B02 Zoster [herpes zoster]; Zoster [herpes zoster]; B02

• Registration Number: PER-101-10
• 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: 2011-02-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• The patient is> 18 years old on the day of signing the informed consent.
• The patient has a previous history of chickenpox, VZV antibodies (documented before receiving blood products), or resides in a country with VZV endemic infection for> 30 years or, if the patient is <30 years old, attended a Primary or secondary school in a country with VZV endemic infection.
• The patient is scheduled to undergo an autologous HCT for the treatment of lymphoma or other indication, including any other malignancy or an indication that is not a malignancy within 60 days of enrollment.
• The patient is highly unlikely to conceive for a period of time from 2 weeks prior to enrollment until 6 months after the last dose of vaccination,
• All potentially fertile female patients should have a serum or urine pregnancy test with a negative result.
• The patient understands the study procedures and agrees to participate in the study by providing written informed consent.
• The patient can understand and fill out the study questionnaires.

Exclusion Criteria

• The patient has a history of hypersensitivity reaction to any component of the vaccine, such as gelatin or neomycin (a history of neomycin contact dermatitis is not a criterion for exclusion from the study).
• The patient has a previous history of HZ within 1 year of enrollment.
• The patient has a previous history of receiving any vaccine against chickenpox or shingles.
• The patient has had more than 2 relapses of their underlying cancer. If the underlying cancer of the patient is Hodgkin lymphoma, more than 2 relapses are allowed.
• The patient is expected to undergo a tandem transplant procedure.
• The patient is expected to receive> 6 months (> I80 days) of prophylactic antiviral therapy after HCT.
• The patient is pregnant or breastfeeding or expects to conceive within the period of 2 weeks prior to enrollment until 6 months from the last dose of vaccination.
• The patient has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 to 28 days Postdose 4.
• The patient has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days before and 28 days after Dose 1 to 4.
• The patient is unlikely to adhere to study procedures or keep appointments.
• Any other reason that, in the opinion of the researcher, could interfere with the evaluation required by the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified