Ad26.Mos4.HIV is a tetravalent vaccine candidate containing recombinant adenovirus serotype 26 (Ad26) vectors with mosaic inserts.
Ad26.Mos4.HIV is being developed as an anti-HIV vaccine.
This vaccine candidate is administered via an intramuscular (IM) injection into the left deltoid.
In the clinical trial, participants will receive Ad26.Mos4.HIV 5*10^10 virus particles (vp) as 0.5 milliliter (mL) via (IM) injection into the left deltoid on Months 0, 3, 6, and 12 and Clade C gp140 (250 [microgram] mcg) mixed with Aluminum phosphate adjuvant as 0.5 mL IM into the right deltoid on Months 6 and 12.
May 30, 2019, Janssen Vaccines & Prevention B.V. announced they have finished the recruitment of 2600 women for the phase 2b clinical trial for Ad26.Mos4.HIV.
Clinical Trial NCT03060629: A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.