Key population groups in eight countries expected to join journey

SEATTLE — JULY 16, 2019 — Approximately 55 clinical research sites in South America, the U.S. and Europe, are geared to participate in a new large-scale HIV vaccine efficacy clinical trial, called Mosaico (HVTN 706/HPX3002).  At the upcoming 10th IAS Conference on HIV Science (IAS 2019) taking place July 21-24 in Mexico City, the HIV Vaccine Trials Network, headquartered at Fred Hutchinson Cancer Research Center, and a global consortium of partners will describe how the next candidate preventive HIV vaccine regimen will move forward in a clinical trial to test its efficacy among cisgender men and transgender people who have sex with men.  Study teams will seek to enroll 3,800 healthy HIV negative at-risk study participants between the ages 18 – 60 years who would benefit most from a preventive HIV vaccine – those without an existing highly effective HIV prevention strategy.  The randomized, double-blind, placebo-controlled trial is expected to get underway later this year.     

Globally, there are an estimated 25 million transgender people who are 49 times more at risk of living with HIV.  Men who have sex with men account for 66% of new HIV infections in the US, and account for a substantial proportion of new infections throughout North and South America, as well as some parts of Europe.  Mosaico will bolster efforts to develop a safe and effective HIV vaccine for populations at risk of HIV acquisition.

“These public-private partnerships are critical to develop a globally effective HIV vaccine.  No one organization can take on HIV alone.”, said Larry Corey M.D., Principal Investigator of the HVTN.  “The HVTN is appreciative of the ability to work with a global consortium of partners in this program”.

Finding a safe and effective HIV vaccine is challenging.  HIV is genetically diverse, more so than any other pathogen, has a complex outer structure or envelope and the HIV subtypes in the different regions vary.  Mosaico will evaluate an investigational vaccine based on “mosaic” immunogens – vaccine components comprising elements from multiple HIV variants – that aim to induce immune responses against a wide variety of global HIV strains.

“The search for a vaccine began the moment HIV was first identified over 35 years ago, but there have been many challenges along the way due to the unique properties of this virus, including its global genetic diversity,” said Johan Van Hoof, M.D., Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV. “Janssen is committed to advancing clinical trials to help build an HIV-free future. With each new study we are working to optimize the mosaic-based vaccine regimen.”

Study participants will receive vaccinations at four time points over one year and will be randomly assigned to receive either the experimental vaccine regimen or placebo.  All study participants will receive a comprehensive HIV prevention package, including risk reduction counselling, condoms and lubricant, STI testing and treatment, and PrEP.  Each study site will provide access to PrEP informed by a locally developed PrEP plan.  Access to PrEP in each country will be made available to study participants where it is licensed, or through local demonstration projects, where available.  

“We are committed to ensuring that HIV vaccine trial results are generalizable to the populations that carry the greatest burden of HIV infection”, said Susan Buchbinder, M.D., Mosaico Protocol Chair and Director of Bridge HIV at the San Francisco Department of Health.

The Mosaico trial is an extension of the public-private partnership between HVTN, the National Institutes of Health (NIH) and the Janssen Pharmaceutical Companies, part of Johnson & Johnson, that was initiated in 2016 when the Ad26-Mosaic based constructs were initially clinically tested.  In preclinical trials, regimens with mosaic-based vaccines were highly efficacious in protecting nonhuman primates against infection with HIV-like viruses.  The mosaic vaccines were tested extensively in phase 1/2a human studies, APPROACH and TRAVERSE (HVTN 117/HPX2004), and more recently in ASCENT (HVTN 118/HPX2003) – each trial showing improved vaccine designs. 

• APPROACH showed that the best combination for a mosaic vaccine is an adenovirus-based viral vector with an HIV mosaic envelope insert given four times, with the addition of an HIV-1 Clade C Env protein added to the last two vaccinations.
• HVTN 117/HPX2004 (TRAVERSE) showed that this regimen is improved when two types of mosaic envelopes are included in the adenovirus-based vaccine.
• Positive outcomes from the APPROACH and HVTN 117/HPX2004 studies led to the initiation in November 2017 of a large efficacy study, the 2,600-person phase 2b trial HVTN 705/HPX2008 or “Imbokodo,” in at risk women in southern Africa.  Imbokodo uses the adenovirus mosaic construct Ad26.Mos4.HIV four dose regimen with Clade C Env protein added to the last two doses, and initial results are anticipated in 2021.
• HVTN 118/HPX2003 (ASCENT) was initiated to test whether adding a mosaic Env protein to the clade C Env protein given in the last two vaccinations will broaden the immune response for Clade B and other non-Clade C HIV-1 viruses. Results from ASCENT will be presented as a late-breaker at IAS 2019.     
• In Mosaico (HVTN 706/HPX3002), the vaccine regimen studied in ASCENT containing mosaic Env protein will be evaluated to see if it protects against HIV acquisition.           

“We believe that engaging and involving communities before and during a clinical trial not only leads to better science, but it helps to support community awareness and ownership,”

said Stephaun Wallace Ph.D., Social and Behavioral Sciences Junior Investigator Liaison at the HVTN and Staff Scientist in the Vaccine and Infectious Diseases Division at Fred Hutch.  “We view communities as partners in the research enterprise and not just as study participants.”   

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Public-private Partnership making the search for a safe and effective HIV vaccine possible

Mosaico is supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH); and the NIAID-funded HIV Vaccine Trials Network (HVTN). Additional partners providing support include the U.S. Army Medical Research and Development Command (USAMRDC). The study will be conducted at approximately 55 clinical sites worldwide.

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