A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
NCT ID: NCT00535236
Last Updated: 2019-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
341 participants
INTERVENTIONAL
2007-11-02
2010-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Autologous HCT-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
Autologous HCT-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Allogeneic HCT-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
Allogeneic HCT-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
STM-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
STM-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
HM-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
HM-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
HIV-V212
Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
HIV-Placebo
Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Interventions
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V212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
Placebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Eligibility Criteria
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Inclusion Criteria
* HIV-infected participants with a baseline CD4 cell count \< or = to 200 cells/mm\^3
* Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies
Exclusion Criteria
* Prior history of HZ
* Prior history of receipt of any varicella or zoster vaccine
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Zorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2.
Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.
Mullane KM, Winston DJ, Wertheim MS, Betts RF, Poretz DM, Camacho LH, Pergam SA, Mullane MR, Stek JE, Sterling TM, Zhao Y, Manoff SB, Annunziato PW. Safety and immunogenicity of heat-treated zoster vaccine (ZVHT) in immunocompromised adults. J Infect Dis. 2013 Nov 1;208(9):1375-85. doi: 10.1093/infdis/jit344. Epub 2013 Aug 1.
Other Identifiers
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2007_608
Identifier Type: OTHER
Identifier Source: secondary_id
V212-002
Identifier Type: OTHER
Identifier Source: secondary_id
V212-002
Identifier Type: -
Identifier Source: org_study_id
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