A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)

NCT00535236 | Completed Phase 1 Results

• 2 other identifiers: V212-0022007_608
• Study Type: interventional
• Target: 341
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm\^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.

Conditions

Herpes Zoster; Herpes Zoster-related Complications

Keywords

Prevention of herpes zoster and HZ-related complications

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)

  Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

  Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)

• Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay

  Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

  Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)

• Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

  An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.

  up to 28 days post vaccination 4 (up to ~Day 118)

Secondary Outcomes (3)

• Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)

  Up to Day 5 post any vaccination

• Percentage of Participants With a Systemic Adverse Event Prompted on the VRC

  Up to 28 days post vaccination 4 (up to ~118 days)

• Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC

  Up to 28 days post any vaccination (up to ~118 days)

Study Arms (10)

Autologous HCT-V212

EXPERIMENTAL

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.

Biological: V212

Autologous HCT-Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Allogeneic HCT-V212

EXPERIMENTAL

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.

Biological: V212

Allogeneic HCT-Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

STM-V212

EXPERIMENTAL

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.

Biological: V212

STM-Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

HM-V212

EXPERIMENTAL

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.

Biological: V212

HM-Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

HIV-V212

EXPERIMENTAL

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.

Biological: V212

HIV-Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

V212 BIOLOGICAL

0.65 ml V212 in 4 dose regimen. Treatment period of 125 days

Allogeneic HCT-V212; Autologous HCT-V212; HIV-V212; HM-V212; STM-V212

Placebo BIOLOGICAL

0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days

Allogeneic HCT-Placebo; Autologous HCT-Placebo; HIV-Placebo; HM-Placebo; STM-Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women \> or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment
• 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

You may not qualify if:

• History of allergy to any vaccine component
• Prior history of HZ
• Prior history of receipt of any varicella or zoster vaccine

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• 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.

  PMID: 40396505 DERIVED

• 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.

  PMID: 40237463 DERIVED

• 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.

  PMID: 23908479 DERIVED

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: November 2, 2007
• Primary Completion: January 25, 2010
• Study Completion: January 26, 2010
• Last Updated: May 20, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share