Clade C and Mosaic gp140 HIV bivalent vaccine / J&J - LARVOL DELTA

MOSAICO: 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 (clinicaltrials.gov) - P3 | N=3900 | Completed | Sponsor: Janssen Vaccines & Prevention B.V. | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

MOSAICO: 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 (clinicaltrials.gov) - P3 | N=3900 | Active, not recruiting | Sponsor: Janssen Vaccines & Prevention B.V. | Trial completion date: Mar 2024 ➔ Aug 2023

Trial completion date • Human Immunodeficiency Virus • Infectious Disease

MOSAICO: 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 (clinicaltrials.gov) - P3 | N=3900 | Active, not recruiting | Sponsor: Janssen Vaccines & Prevention B.V. | Trial primary completion date: Mar 2024 ➔ Aug 2023

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

MOSAICO: 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 (clinicaltrials.gov) - P3; N=3903; Active, not recruiting; Sponsor: Janssen Vaccines & Prevention B.V.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Human Immunodeficiency Virus • Immunology • Infectious Disease

MOSAICO: 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 (clinicaltrials.gov) - P3; N=3800; Recruiting; Sponsor: Janssen Vaccines & Prevention B.V.; Trial primary completion date: Jan 2023 ➔ Mar 2024

Clinical • Trial primary completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease

4 Ways Johnson & Johnson Has Worked to Make Access to Medicines Around the World More Equitable (J&J Press Release) - "The trials, called Imbokodo and Mosaico, are taking place across four continents and involve populations who are disproportionately vulnerable to contracting HIV: young women in Africa, and men who have sex with other men and transgendered individuals in the Americas and Europe. Initial results from Imbokodo—which has completed its vaccinations—are expected later this year, and results from Mosaico, which is still enrolling participants, should be available in 2024."

P2 data • P3 data • Trial status • Human Immunodeficiency Virus • Infectious Disease

First-ever phase III trials of HIV vaccine in Latin America (Bioworld) - "A phase III trial for an HIV vaccine developed Janssen Vaccines & Prevention BV is finally moving forward in Latin America and elsewhere in the world after a delay of more than a year caused by slow regulatory progress and worsened by a string of COVID-19 lockdowns."

Trial status • Human Immunodeficiency Virus

Kenya: What to Expect in 2021 (All Africa) - "There are three experimental HIV vaccines in the final stages whose results are expected to be released between 2021 and 2023. Scientists say they are optimistic the trial of HVTN 702, Imbokodo and Mosaico will yield good results. HVTN 702 is the oldest vaccine trial. Its development is based on another vaccine candidate, the RV144 whose clinical trial findings showed the vaccine lowered the rate of infection by about 30 per cent. Clinical results for HVTN 702 are expected in 2021. The results for Imbokodo, another vaccine candidate being tried in five southern Africa countries, are expected in 2021....Mosaico trial results are expected to be released in 2023."

Clinical data • P2b data • P3 data • Human Immunodeficiency Virus

MOSAICO: 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 (clinicaltrials.gov) - P3; N=3800; Recruiting; Sponsor: Janssen Vaccines & Prevention B.V.; Trial completion date: Sep 2023 ➔ Mar 2024

Clinical • Trial completion date • Human Immunodeficiency Virus • Immunology • Infectious Disease

MOSAICO: 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 (clinicaltrials.gov) - P3; N=3800; Recruiting; Sponsor: Janssen Vaccines & Prevention B.V.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open