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INO 5401 Vaccination in BRCA1/2 Mutation Carriers

NCT04367675 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-02-23

No results posted yet for this study

Summary

The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Conditions

  • BRCA1/2 Mutation

Interventions

DRUG

INO-5401

INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system both people who have had cancer or for those at increased risk of getting cancer.

DRUG

INO-9012

INO-9012 contains the gene for IL12, a part of your body's immune system. It is possible that adding this to INO-5401 will increase the immune response to the vaccine.

DEVICE

Cellectra 2000

The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.

Sponsors & Collaborators

Principal Investigators

  • Susan Domchek, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367675 on ClinicalTrials.gov