drugset / Trial / NCT00528489
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
Phase 1
Completed
120 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.
Timeline
- Start
- 2007-10
- Primary completion
- 2010-01
- Completion
- 2010-01
Publications
- Background Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
- Background Ogawa H, Ueno M, Uchibori H, Matsumoto I, Seno N. Direct carbohydrate analysis of glycoproteins electroblotted onto polyvinylidene difluoride membrane from sodium dodecyl sulfate-polyacrylamide gel. Anal Biochem. 1990 Nov 1;190(2):165-9. doi: 10.1016/0003-2697(90)90175-9.
- Background McBurney SP, Ross TM. Developing broadly reactive HIV-1/AIDS vaccines: a review of polyvalent and centralized HIV-1 vaccines. Curr Pharm Des. 2007;13(19):1957-64. doi: 10.2174/138161207781039841.
- Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-803 | Protein / enzyme biologic | 0.8 mg | Other |
| Subject | N-803 | Protein / enzyme biologic | 2 mg | Other |
| Subject | PENNVAX-B | Vaccine | — | Other |
| Subject | interleukin-12 | Protein / enzyme biologic | — | Other |