A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine

Summary

To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given intramuscularly To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given intramuscularly

Timeline

Start

2004-08-20

Primary completion

2006-03-13

Completion

2006-11-01

Publications

• Background 1. UNAIDS/WHO. Report on the global HIV/AIDS epidemic.June 2000. 2. Quinn TC. Global burden of the HIV pandemic. Lancet.1996;348:99-106. 3. Moss B. Genetically engineered poxviruses for recombinant gene expression, vaccination, and safety. PNAS 1996;93; 11341-8. 4. Tartaglia J, Excler JL, El Habib R, Limbach K, Meignier B, Plotkin S, Klein M. Canarypoxvirus-based vaccines : prime-boost strategies to induce cell-mediated and humoral immunity against HIV. AIDS Res Hum Retroviruses 1998;14(supp.3): S291-S298. 5. Girard M, Excler JL. Human Immunodeficiency virus. In Vaccines. Plotkin SA and Mortimer EA Eds. Saunders, Philadelphia,1999, pp.928-967. 6. Excler J-L, Plotkin S. The prime-boost concept applied to HIV preventive vaccines. AIDS 1997;11(suppl A):S127-137. 7. Ogg GS, Jin X, Bonhoeffer S, Dunbar PR, Nowak MA, Mopnard S, Segal JP, Cao Y, 8. Rowland-Jones SL, Cerundolo V, Hurley A, Markowwitz M, Ho DD, Nixon DF, McMichael AJ. Quantitation of HIV-1-specific cytotoxic T lymphocytes and plasma load of viral RNA. Science 1998; 279: 2103-6. 8. Schmitz JE, Kuroda MJ, Santra S, Sasseville VG, Simon MA, Lifton MA, Racz P, Tenner-Racz K, Dalesandro M, Scallon BJ, Ghrayeb J, Forman MA, Montefiori DC, Rieber EP, Letvin NL, Reimann KA. Control of viremia in simian immunodeficiency virus infection by CD8 lymphocytes. Science 1999; 283: 857-60. 9. Brodie SJ, Lewinsohn DA, Patterson BK, Jiyamapa D, Krieger J, Corey L, Greenberg P, Riddell SR. In vivo migration and function of transferred HIV-1-specific cytotoxic T cells. Nature Medicine 1999; 5: 34-41. 10. Letvin NL. Progress in development of an AIDS vaccine. Science 1998; 280: 1875-9.

Drugs

Indications