Janssen Ad26.Mos4.HIV Vaccine Description for 2022

Ad26.Mos4.HIV is a tetravalent vaccine candidate that contains a “mosaic” of HIV genes from different subtypes of the virus that researchers stitched into a harmless adenovirus. The subtypes include Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.

Janssen’s mosaic-based vaccine candidate contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes with the goal of delivering a global vaccine that could be deployed anywhere in the world.

In earlier tests, this vaccine did not trigger neutralizing antibodies but produced high levels of binding antibodies and other immune responses. A booster shot consists of a mosaic version of HIV’s surface protein mixed with an alum adjuvant.

Ad26.Mos4.HIV Vaccine Indication

Ad26.Mos4.HIV is being developed as an anti-HIV vaccine.

Ad26.Mos4.HIV Vaccine Dosage

This vaccine candidate is administered via an intramuscular (IM) injection into the left deltoid.

Janssen’s investigational preventive HIV vaccine regimen involves four vaccination visits over one year.

Ad26.Mos4.HIV Vaccine News 2019- 2022

July 23, 2019 - Johnson & Johnson Announces New Clinical Data on Mosaic-based HIV Preventive Vaccine Regimen. The study, ASCENT (HPX2003/HVTN 118), found that adding a bivalent soluble protein to the regimen (a combination of Clade C and Mosaic gp140) improved the breadth of immune responses to different HIV strains circulating worldwide. 

Ad26.Mos4.HIV Vaccine Clinical Trials 

Clinical Trial NCT04983030: Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults. 

This multi-center study has not begun recruiting.  Thirty-six participants ages 19-70 will be recruited for this randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study.

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 Phase 2 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.

Clinical Trial NCT03964415:  A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals (MOSAICO)

• Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions.
• Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant.
• Evidences showed that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to the highest level of protection observed so far with this vaccine concept.
• Study comprises a screening period of 45 days, a 12-month vaccination period and a follow-up period of at least 18 months after fourth vaccination (until Month 30) in participants who remain HIV-1 negative or up to 6 months after diagnosis of HIV-1 infection in participants who become HIV-1 infected. Participants who completed their Month 30 visit will be followed for HIV infection, medically-attended adverse event (MAAEs) and serious adverse events until the end of study (Month 30).
• Primary analysis of vaccine efficacy will evaluate the number of HIV-1 infections in the vaccine group compared to number of HIV-1 infections in the placebo group between Month 7 and Month X (with 24<=X<=30) in per-protocol population.