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PENNVAX-B

Phase 1

HIV-1 Infection | Monoclonal antibody | Infectious Disease |Inovio Pharmaceuticals, Inc.|Last Updated: Nov 9, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PENNVAX-B · 1 trial · 2 indications

Phase 1 1
NCT01082692Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult ParticipantsHIV-1 Infection
COMPLETED12 Analytics
PHASE1COMPLETED
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
HIV-1 InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
Day 0 through Week 48

Frequency and severity of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, including CD4 and HIV RNA viral load changes, and adverse and serious adverse events.

Secondary Endpoints

T-cell responses
Day 0 through Week 48
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
3mg DNA/doseEXPERIMENTALSubjects will receive a 4 dose series of PENNVAX-B containing 3mg of DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8 and Week 16.

Interventions

NameTypeDescription
PENNVAX-BBIOLOGICALDNA plasmids delivered via IM injection + electroporation using CELLECTRA device
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * HIV-1 infection * On a stable HAART regimen for ≥3 months before the time of enrollment * CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment * HIV-1 \< 75 copies/mL on two occasions within 60 days of enrollment * Body mass index (BMI) ≤30 kg/m\^...

Countries:United States
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Frequently asked questions about PENNVAX-B

What is PENNVAX-B used for?

PENNVAX-B is an investigational DNA vaccine being studied for the treatment of HIV-1 infection. It is designed to be administered with electroporation, a technique that uses electrical pulses to enhance delivery of the vaccine into cells. The drug is currently in Phase 1 clinical development.

Who makes PENNVAX-B?

PENNVAX-B is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine for HIV-1 infection.

What phase is PENNVAX-B in?

PENNVAX-B is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is PENNVAX-B in?

PENNVAX-B has been studied in one completed Phase 1 clinical trial with the identifier NCT01082692. The trial was conducted in the United States and enrolled 12 adult participants with HIV-1 infection. The study was uncontrolled, meaning there was no comparator group.

How does PENNVAX-B work?

PENNVAX-B is a DNA vaccine that encodes HIV-1 antigens, including Gag, Pol, and Env. It is administered with electroporation, which uses electrical pulses to increase cellular uptake of the DNA. This approach aims to generate an immune response against HIV-1.