Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants

NCT00722839 | Completed Phase 1 DMC

• 6 other identifiers: City of Hope 03121R01CA077544P30CA033572CHNMC-03121CDR0000599724NCI-2010-01227
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nonneoplastic Condition

Keywords

cytomegalovirus infection

Outcome Measures

Primary Outcomes (2)

• Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity

  3 weeks after the final vaccine dose

• Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909

  1 year after the final vaccine dose

Secondary Outcomes (1)

• Number of CMV-positive and CMV-specific CD8+ T cells/L

  1 year after final vaccine dose

Study Arms (2)

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; Biological: tetanus-CMV fusion peptide vaccine

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; Biological: tetanus-CMV fusion peptide vaccine; Drug: agatolimod sodium

Interventions

PADRE-CMV fusion peptide vaccine BIOLOGICAL

Given subcutaneously

Group A; Group B

tetanus-CMV fusion peptide vaccine BIOLOGICAL

Given subcutaneously

Group A; Group B

agatolimod sodium DRUG

Given subcutaneously

Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Related Publications (1)

• La Rosa C, Longmate J, Lacey SF, Kaltcheva T, Sharan R, Marsano D, Kwon P, Drake J, Williams B, Denison S, Broyer S, Couture L, Nakamura R, Dadwal S, Kelsey MI, Krieg AM, Diamond DJ, Zaia JA. Clinical evaluation of safety and immunogenicity of PADRE-cytomegalovirus (CMV) and tetanus-CMV fusion peptide vaccines with or without PF03512676 adjuvant. J Infect Dis. 2012 Apr 15;205(8):1294-304. doi: 10.1093/infdis/jis107. Epub 2012 Mar 7.

  PMID: 22402037 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• John A. Zaia, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 28, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 25, 2012

Record last verified: 2012-06

Locations

US (1)