Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-Sig/E7(Detox)/HSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 18, 2023

Primary Completion Date

April 18, 2027

Study Completion Date

October 18, 2027

Conditions
HPV 16 InfectionHPV-Related CarcinomaRecurrenceMetastatic Cancer
Interventions
BIOLOGICAL

pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus

"About 1 month before donating blood, donors are required to come to outpatient clinic once a week to receive the following vaccine series:~Week 1: PVX1 (1 of 3): intramuscular injection (IM) of 3mg DNA prime with pNGVL4a-Sig/E7(detox)/HSP70 vaccine Week 2: PVX1 (2 of 3): IM 3mg DNA prime with pNGVL4a-Sig/E7(detox)/HSP70 vaccine Week 3: PVX1 (3 of 3): IM TA-HPV vaccinia boost Pause for 2 weeks Peripheral blood collection and possible bone marrow harvest depending on randomization"

Trial Locations (1)

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

PapiVax Biotech, Inc.

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER