A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus
- 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
- To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines
in combination with PF 03512676 DNA in these participants.
- 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 PF 03512676 DNA.
- To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative
- 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
- 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.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
John A. Zaia, MD
Beckman Research Institute
United States: Food and Drug Administration
City of Hope 03121
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|