A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2011-002313-11-BE
• Date of registration: 02/02/2012
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
• Public title: A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease
• Scientific title: A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease - V212 in Adult Patients with Autoimmune Disease
• Date of first enrolment: 17/04/2012
• Target sample size: 340
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002313-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Colombia, Denmark, Estonia, Israel, Netherlands, New Zealand, Peru, Romania, Spain, Sweden, United States

Contacts

• Name: Janie Parrino
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Name: Janie Parrino
• Affiliation: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Patient is =18 years of age with an autoimmune disease, has clinically stable disease for =30 days prior to enrollment, is receiving treatment with at least one biologic agent or non-biologic therapy at a stable dose for =3 months, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for =30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, and is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

Exclusion criteria:
Patient has a history of herpes zoster within 1 year of enrollment, has a history of receipt of any varicella or zoster vaccine, has or will receive treatment with any anti-CD20 monoclonal antibody within the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is likely to receive any live virus vaccine during the period from 4 weeks prior to enrollment through 28 days following the last dose of study vaccine, or is likely to receive any inactivated vaccine during the period from 7 days prior to, through 7 days following, any dose of study vaccine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prevention of herpes zoster in adults with autoimmune disease
MedDRA version: 14.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: Inactivated Varicella Zoster Virus Vaccine
Product Code: V212
Pharmaceutical Form: Injection
INN or Proposed INN: V212
Other descriptive name: Varicella Zoster virus Inactivated
Concentration unit: AgU/ml antigen unit(s)/millilitre
Concentration type: equal
Concentration number: 17.4-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Product Name: Inactivated Varicella Zoster Virus Vaccine
Product Code: V212
Pharmaceutical Form: Injection
INN or Proposed INN: V212
Other descriptive name: Varicella Zoster virus Inactivated
Concentration unit: AgU/ml antigen unit(s)/millilitre
Concentration type: equal
Concentration number: 99-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: 1) To determine whether V212 is immunogenic when administered to adult patients with autoimmune disease.
2) To assess the safety and tolerability of V212 in adult patients with autoimmune disease.

Timepoint(s) of evaluation of this end point: Day 1 (prior to Dose 1) and Visit 5 (28 days Postdose 4 [+7 days])

Secondary Objective: None

Primary end point(s): The primary immunogenicity endpoint is the GMFR of the VZV-specific immune responses from prevaccination to ~28 days Postdose 4.

Secondary Outcome(s)

Secondary end point(s): None

Timepoint(s) of evaluation of this end point: None

Secondary ID(s)

2011-002313-11-SE

V212-009

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.