A Phase III Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy

• Register: KCT
• Last refreshed on: 27 May 2013
• Main ID: KCT0000393
• Date of registration: 30/03/2012
• Primary sponsor: MSD Korea LTD
• Public title: A Phase III Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
• Scientific title: A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
• Date of first enrolment: 2011-10-14
• Target sample size: 5264
• Recruitment status: Recruiting
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1920
• Study type: Interventional Study
• Study design: Primary Purpose : Prevention, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Caregiver, Allocation : RCT

Countries of recruitment

Korea, Republic of

Contacts

• Name: Eun Hee Park
• Affiliation: Seoul National University Hospital

• Name: Sung-Soo Yoon
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patient has been diagnosed with a solid tumor or hematologic malignancy AND is not likely to undergo hematopoietic cell transplant (HCT) and meets one of the criteria specified below.
- Is 18 years of age or older and is receiving a cytotoxic or immunosuppressive chemotherapy regimen that does not include an anti-CD20 monoclonal antibody
- Is 50 years of age or older with a hematologic malignancy, not in remission, regardless of whether the patient is or is not receiving chemotherapy
- Is not receiving and not expected to require anti-CD20 monoclonal antibody therapy beginning 3 months prior to enrollment through 28 days postvaccination dose 4.
2. Life expectancy = 12 months.
3. Signed an informed consent prior to any study procedures.
4. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for =30 years) in a country with endemic VZV infection, or if participant is <30 years old, attended primary or secondary school in a country with endemic VZV infection (see Section 3.2.8 for more details).
5. All female patients of childbearing potential (as defined below under #7) must have a negative serum or urine pregnancy test (sensitive to 25IU ß-hCG).
6. Able to understand and complete study questionnaires.
7. Patient is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose, as indicated by at least one “yes” answer to the following questions:
- Patient is male.
- Patient is female who agrees to remain abstinent or use (or have their partner use) adequate contraception during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose. Note that simultaneous use of two reliable forms of contraception is recommended.
- Patient is a female who is not of reproductive potential. A female patient who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) post-surgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation.
8. Patients with STM will be eligible for enrollment if they have not received (nor are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.
Exclusion criteria: 1. A history of allergic reaction to any vaccine component (including 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 or expected receipt of any varicella or non-study zoster vaccine.
4. Patient is currently receiving or expected to receive long-term antiviral prophylaxis (greater than 4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV).
5. Patient is receiving or expected to receive a chemotherapy regimen containing an anti-CD20 monoclonal antibody at any time during the time period beginning 3 months prior to enrollment through 28 days postvaccination dose 4.
6. Patient is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
7. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
8. Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
9. Unlikely to adhere to the study procedures or attend study visits.
10. Any other reason that in the opinion of the investigator might interfere with the evaluation required by the study.
11. Patients with STM will be excluded from study if they have received (or are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.


Age minimum: 20(Year)
Age maximum: N/A(No Limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Not Applicable

Intervention(s)

Drug : Drug Name: V212 or placebo, Dose: 0.5 ml, Frequency: 4 times, Period: approximately 30 days following each previous dose, Route: subcutaneous injection in the deltoid region of the arm, Randomized 1:1 to receive either V212 or placebo

Primary Outcome(s)

Efficacy : The incidence of HZ, moderate to severe HZ-associated pain, HZ complications, and PHN

Safety : Vaccine Report Card (VRC) and SAE

Secondary Outcome(s)

Immunogenicity : the VZV antibody titers as measured by gpELISA in all subjects from STM group

Secondary ID(s)

NCT01254630

Secondary Sponsor(s)

MSD Korea LTD