Cytomegalovirus Vaccine in Healthy Participants

NCT00712634 | Completed Phase 1

• 3 other identifiers: CDR0000599675P01CA030206CHNMC-97092
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Precancerous/Nonmalignant Condition

Keywords

cytomegalovirus infection

Outcome Measures

Primary Outcomes (3)

• Safety and toxicity

• Immunologic response

• Duration of immunologic response

Study Arms (2)

CMV-seropositive participants

EXPERIMENTAL

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

CMV-seronegative participants

EXPERIMENTAL

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

Interventions

CMVpp65-A*0201 peptide vaccine BIOLOGICAL

Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90

CMV-seronegative participants; CMV-seropositive participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Don Diamond, PhD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 10, 2008
• Study Start: November 1, 1997
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: December 21, 2009

Record last verified: 2009-12

Locations

US (1)