J&J reports first-in-human data for mosaic vaccine to prevent HIV infection

The Janssen Vaccines & Prevention B.V. unit of Johnson & Johnson (NYSE:JNJ) reported data from the Phase I/IIa APPROACH trial in 393 HIV-uninfected healthy volunteers showing that various mosaic-based prime-boost vaccine regimens utilizing the mosaic viral vector Ad26.Mos.HIV elicited HIV-1 antibody responses in 100% of subjects. Additionally, antibody titers against autologous HIV clade C and heterologous cross-clade HIV env antigens increased in subjects boosted with the clade C gp140 soluble protein. After the 4th vaccination, Janssen said humoral and cellular responses further increased. Ad26.Mos.HIV was well tolerated. Data were presented at the International AIDS Society Conference on HIV Science in Paris.

The double-blind, placebo-controlled trial enrolled healthy volunteers from the U.S., Rwanda, Uganda, South Africa and Thailand. Ad26.Mos.HIV is a recombinant replication-deficient HIV vaccine containing 3 adenovirus serotype 26 (Ad26) vectors with mosaic inserts. Subjects received vaccine regimens containing 2 prime doses of Ad26.Mos.HIV at weeks 0 and 12 followed by 2 boosts of either Ad26.Mos.HIV, modified vaccinia Ankara (MVA)-Mosaic, and/or different doses of the clade C gp140 soluble protein adjuvanted with aluminum phosphate at weeks 24 and 48. MVA-Mosaic is a recombinant live-attenuated virus-vectored vaccine genetically engineered to express 2 mosaic gag polyprotein, pol and HIV env sequences...