Cytomegalovirus Vaccine in Healthy Participants - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00712634

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 I

MedlinePlus related topics: Cytomegalovirus Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	A Phase I Dose Escalation Study of Lipopeptide Vaccines With Activity Against Human Cytomegalovirus

Further study details as provided by National Cancer Institute (NCI):

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
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

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

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

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

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

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

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Don Diamond, PhD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Comprehensive Cancer Center ( Don Diamond )
Study ID Numbers:	CDR0000599675, CHNMC-97092
Study First Received:	July 9, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00712634 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cytomegalovirus infection

Study placed in the following topic categories:

Virus Diseases
Precancerous Conditions
Cytomegalic Inclusion Disease
Cytomegalovirus Infections

DNA Virus Infections
Healthy
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:

Virus Diseases
Neoplasms
Precancerous Conditions

Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009