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PENNVAX-B · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 3mg DNA/dose | EXPERIMENTAL | Subjects 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. |
| Name | Type | Description |
|---|---|---|
| PENNVAX-B | BIOLOGICAL | DNA plasmids delivered via IM injection + electroporation using CELLECTRA device |
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\^...
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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.
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.
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.
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.
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.