Vaccine Therapy in Preventing Cytomegalovirus 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:	NCT00722839

Purpose

RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus.

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

Condition	Intervention	Phase
Precancerous/Nonmalignant Condition	Biological: PADRE-CMV fusion peptide vaccine Biological: tetanus-CMV fusion peptide vaccine Drug: agatolimod sodium	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Agatolimod sodium

U.S. FDA Resources

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

Primary Outcome Measures:

Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity [ Designated as safety issue: Yes ]
Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of CMV-positive and CMV-specific CD8+ T cells/L [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	December 2006
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.	Biological: PADRE-CMV fusion peptide vaccine Given subcutaneously Biological: tetanus-CMV fusion peptide vaccine Given subcutaneously
Group B: Experimental Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.	Biological: PADRE-CMV fusion peptide vaccine Given subcutaneously Biological: tetanus-CMV fusion peptide vaccine Given subcutaneously Drug: agatolimod sodium Given subcutaneously

Detailed Description:

OBJECTIVES:

Primary

To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or -seronegative participants.
To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines in combination with CpG 7909 DNA in these participants.

Secondary

To provide preliminary evidence of enhanced cellular immunity to CMV at levels of T cells that would support potential feasibility if such cells were to be transferred from the donor to recipients of hematopoietic stem cell transplantation (HSCT) in amounts consistent with protection against disease.
To determine whether a reduced dose of peptide vaccine can be immunogenic in combination with CpG 7909 DNA.
To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative participants.
To determine the duration of immune enhancement of CMV-specific CTL function up to 12 months following immunization of healthy participants.

OUTLINE: This is a dose-escalation study of PADRE-CMV and tetanus-CMV fusion peptide vaccines. Participants are stratified according to cytomegalovirus (CMV) serum status (positive vs negative). Participants are assigned to 1 of 2 groups.

Group A: Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
Group B: Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity. Participants are contacted by telephone every 3-7 days after immunization. Participants also complete a notebook on any health-related event for 14 days after each immunization.

Participants undergo blood sample collection at baseline and periodically during study for immunologic laboratory studies, including flow cytometry, by HLA-A2-CMV-tetramer, CMV-specific intracellular cytokine, CMV-specific CD107 degranulation, lymphoproliferation, and chromium release assays.

After completion of study therapy, participants are followed for up to 1 year.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Cytomegalovirus (CMV) seropositivity or seronegativity
HLA A*0201 positive OR positive tetramer-binding using CMV peptide 495-503 with HLA A2 subtypes other than HLA A*0201
A2-CMV-Tet cells ≤ 10^8/L

PATIENT CHARACTERISTICS:

Platelet count within 1.5 times upper level of normal (ULN)
The following blood and chemistry studies must be normal:
- Sodium
- Potassium
- Chloride
- Carbon dioxide
- Glucose
- BUN
- Creatinine
- Uric acid
- WBC
- Hemoglobin
- Hematocrit
The following studies must be ≤ ULN:
- Albumin
- Alkaline phosphatase
- AST and ALT
- Lactic dehydrogenase
- Total bilirubin
Hepatitis B virus surface antigen negative
Hepatitis C virus seronegative
No diagnosis that is associated with immunodeficiency (e.g., HIV)
No active infection that requires treatment
No known cardiac disease including hypertension and/or high cholesterol
No serious abnormalities by EKG (in participants ≥ 50 years of age)
Not pregnant
Negative pregnancy test
Fertile participants must use effective contraception during study and for 6 weeks after the fourth and last dose of vaccine
No history of allergic reaction to tetanus toxoid
No history of any of the following:
- Cancer other than basal cell carcinoma of the skin
- Depression
- Allergic diathesis, as defined by a history of asthma
- Anaphylaxis
- Generalized urticaria or daily use of antihistamines
- Episodic (more than once in the past 3 months) inhalational medications including steroidal agents
- Non-steroidal agents or cromolyn sodium
- Frequent migraines, defined as 3 or more episodes in the past year
No prior or concurrent infectious condition

PRIOR CONCURRENT THERAPY:

More than 6 months since prior participation in a CMV immunotherapy trial
More than 30 days since prior live vaccine
More than 2 weeks since prior inactivated vaccine
No concurrent daily medications for chronic or current illness, except for the following:
- Thyroid-replacement therapy
- Estrogen-replacement therapy
- Dietary vitamins and protein supplements
- Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
No surgery in the past 6 months that required general anesthesia
- Minor procedures (e.g., dental surgery or superficial diagnostics biopsies) allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722839

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John A. Zaia, MD

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 ( John A. Zaia )
Study ID Numbers:	CDR0000599724, CHNMC-03121
Study First Received:	July 25, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00722839 History of Changes
Health Authority:	Unspecified

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 September 11, 2009