Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants

Phase 1 Completed 68 enrolled City of Hope Medical Center National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2006-12
Primary completion: 2012-04
Completion: 2012-04

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PADRE-CMV fusion peptide vaccine	Vaccine	0.5 mg	Subcutaneous
Subject	PADRE-CMV fusion peptide vaccine	Vaccine	2.5 mg	Subcutaneous
Subject	PADRE-CMV fusion peptide vaccine	Vaccine	10 mg	Subcutaneous
Subject	agatolimod	Oligonucleotide (other)	—	Subcutaneous
Subject	tetanus-CMV fusion peptide vaccine	Vaccine	0.5 mg	Subcutaneous
Subject	tetanus-CMV fusion peptide vaccine	Vaccine	2.5 mg	Subcutaneous
Subject	tetanus-CMV fusion peptide vaccine	Vaccine	10 mg	Subcutaneous

Indications

No indication recorded.