Cytomegalovirus Vaccine in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00712634
First received: July 9, 2008
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

RATIONALE: Vaccines may help the body build an effective immune response against cytomegalovirus.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of cytomegalovirus vaccine in healthy participants.


Condition Intervention Phase
Precancerous/Nonmalignant Condition
Biological: CMVpp65-A*0201 peptide vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Safety and toxicity [ Designated as safety issue: Yes ]
  • Immunologic response [ Designated as safety issue: No ]
  • Duration of immunologic response [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: November 1997
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CMV-seropositive participants
Participants are randomized to receive 1 of 4 escalating doses of CMVpp65-A*0201 peptide vaccine containing either helper T-lymphocyte (HTL) PADRE peptide or HTL tetanus toxoid peptide. Within each vaccine dose group, two participants are randomized to receive a placebo. Participants receive the vaccine or a placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.
Biological: CMVpp65-A*0201 peptide vaccine
Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90
Experimental: CMV-seronegative participants
Participants are randomized to receive 1 of 4 established doses (established in CMV-seropositive participants) of CMVpp65-A*0201 peptide vaccine containing either HTL PADRE peptide or HTL tetanus toxoid peptide. Participants receive the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity. Participants with a partial or low-level immune response receive one additional booster vaccine on day 90.
Biological: CMVpp65-A*0201 peptide vaccine
Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90

Detailed Description:

OBJECTIVES:

  • To establish whether 4 dose levels of the CMVpp65-A*0201 peptide vaccine are safe and well tolerated in cytomegalovirus (CMV)-seropositive participants.
  • To determine whether the CMVpp65-A*0201 peptide vaccine, when given as a single injection followed by one booster injection at a safe and well-tolerated dose, is capable of stimulating a memory response in CMV-seropositive participants.
  • To evaluate whether CMV-seronegative participants generate a de novo immune response against CMV after immunization with CMVpp65-A*0201 peptide vaccine given as a single injection followed by three booster injections.
  • To determine the duration of immune enhancement of CMV-specific cytotoxic T-lymphocyte function as assessed for up to 12 months after primary or secondary immunization with the CMVpp65-A*0201 peptide vaccine.

OUTLINE: This is a dose-escalation study of CMVpp65-A*0201 peptide vaccine in cytomegalovirus (CMV)-seropositive participants. Once a safe dose is established, CMV-seronegative participants are accrued and immunized at that dose. Participants are stratified according to gender.

  • CMV-seropositive participants: Participants are randomized to receive 1 of 4 escalating doses of CMVpp65-A*0201 peptide vaccine containing either helper T-lymphocyte (HTL) PADRE peptide or HTL tetanus toxoid peptide. Within each vaccine dose group, two participants are randomized to receive a placebo. Participants receive the vaccine or a placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.
  • CMV-seronegative participants: Participants are randomized to receive 1 of 4 established doses (established in CMV-seropositive participants) of CMVpp65-A*0201 peptide vaccine containing either HTL PADRE peptide or HTL tetanus toxoid peptide. Participants receive the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity. Participants with a partial or low-level immune response receive one additional booster vaccine on day 90.

Participants undergo blood sample collection at baseline and periodically during study for immunologic laboratory studies. Participants also undergo skin biopsy at baseline. Laboratory studies include assessment of human cytotoxic T-lymphocyte activity and response by ^51chromium-release assay, limiting-dilution analysis, and T-cell proliferation assay; and CD4/CD8 phenotyping by FACScan® flow cytometry.

After completion of study therapy, participants are followed for 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy participant
  • Cytomegalovirus seropositive or seronegative
  • HLA-A*0201-positive

PATIENT CHARACTERISTICS:

  • CBC within 1.5 times normal
  • SMA-18 within 1.5 times normal
  • Hepatitis B virus antigen seronegative
  • Hepatitis C virus seronegative
  • No diagnosis that is associated with immunodeficiency, including HIV infection
  • No serious abnormalities by EKG (in participants ≥ 50 years of age)
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior surgery
  • No concurrent daily medications for chronic or current illness, except for the following:

    • Thyroid replacement therapy
    • Estrogen replacement therapy
    • Dietary vitamins and protein supplements
    • Antihistamine medication
    • Anticholesterol medication
    • Cardiac and antihypertensive medication
    • Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712634

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Don Diamond, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Don Diamond, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00712634     History of Changes
Other Study ID Numbers: CDR0000599675, P01CA030206, CHNMC-97092
Study First Received: July 9, 2008
Last Updated: December 18, 2009
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
cytomegalovirus infection

Additional relevant MeSH terms:
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014