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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Precancerous/Nonmalignant Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and toxicity

Safety Issue:

Yes

Principal Investigator

Don Diamond, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000599675

NCT ID:

NCT00712634

Start Date:

November 1997

Completion Date:

April 2009

Related Keywords:

  • Precancerous/Nonmalignant Condition
  • cytomegalovirus infection
  • Precancerous Conditions

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010