A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus

NCT00722839 Phase 1 COMPLETED

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.

Details

Lead sponsor	City of Hope Medical Center
Phase	Phase 1
Status	COMPLETED
Enrolment	68
Start date	2006-12
Completion	2012-04

Conditions

• Nonneoplastic Condition

Interventions

• PADRE-CMV fusion peptide vaccine
• tetanus-CMV fusion peptide vaccine
• agatolimod sodium

Primary outcomes

• 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

Countries

United States