Cytomegalovirus Vaccine in Healthy Participants

Precancerous/Nonmalignant Condition Clinical Trial

Official title:

A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712634
• Other study ID #: CDR0000599675
• Secondary ID: P01CA030206CHNMC
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2008
• Last updated: December 18, 2009
• Start date: November 1997
• Est. completion date: April 2009

Study information

• Verified date: December 2009
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Precancerous Conditions
• Precancerous/Nonmalignant Condition

Intervention

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

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and toxicity			Yes
Primary	Immunologic response			No
Primary	Duration of immunologic response			No