Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults
Summary
An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or without an IL-12 adjuvant when given using electroporation.
Description
An effective and safe vaccine must be developed in order to halt the HIV pandemic. The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation.
Participants in this study will be randomly assigned to one of three groups and will visit the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment. These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and 3.
At clinic visits participants will have physical exams and blood and urine collected. After receiving study injections, participants will be observed in the clinic for at least 30 minutes. In addition, participants will be asked to monitor symptoms for 3 days after each injection.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Conditions
HIV Infections
Intervention
PENNVAX-B, IL-12 DNA plasmids
Location
Univ. of Rochester HVTN CRS
Rochester
New York
United States
14642-0001
Status
Active, not recruiting
Source
National Institute of Allergy and Infectious Diseases (NIAID)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00991354
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:18:47-0400
Clinical Trials
PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection
A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expre...
The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection...
In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients. The HI...
Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3
DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. ...
Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults
DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in h...
PubMed Articles
We report the first-in-human safety and immunogenicity evaluation of PENNVAX®-G DNA/ MVA-CMDR prime-boost HIV vaccine, with intramuscular DNA delivery by either Biojector® 2000 needle free injection...
The bacterial enzyme New Delhi metallo-β-lactamase hydrolyzes almost all β-lactam antibiotics, including carbapenems, which are drugs of last resort for severe bacterial infections. The spread of ca...
Of 11 mcr-1-harboring plasmids previously identified from livestock in Korea, we performed whole plasmid sequencing on 3 plasmids and determined the genetic structure surrounding mcr-1 for all 11 plas...
Conjugative plasmids represent major reservoirs for horizontal transmission of antibiotic resistance (AR) and virulence genes. Our knowledge about the ecology and persistence of these plasmids in the ...
Plasmids carrying antimicrobial resistance genes in Enterobacteriaceae.
Bacterial antimicrobial resistance (AMR) is constantly evolving and horizontal gene transfer through plasmids plays a major role. The identification of plasmid characteristics and their association wi...
Medical and Biotech [MESH] Definitions
Bacteriocin Plasmids
Plasmids encoding bacterial exotoxins (BACTERIOCINS).
Encephalitis, Viral
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Meningitis, Viral
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Paramyxoviridae Infections
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
Plant Tumor-inducing Plasmids
Plasmids coding for proteins which induce PLANT TUMORS. The most notable example of a plant tumor inducing plasmid is the Ti plasmid found associated with AGROBACTERIUM TUMEFACIENS.
