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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5264

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
- 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

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. 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:
- 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.

7. 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.
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 1316
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3948

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 pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
6. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
7. Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
8. Patients with STM will be excluded from the ELISPOT substudy if they have received (or are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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