Mosaico (also known as HVTN 706/HPX3002) is a large efficacy study testing an investigational vaccine regimen to prevent HIV. The study vaccine regimen consists of Ad26.Mos4.HIV (Ad26 vaccine) and Clade C and Mosaic gp140 (gp140 vaccine). The main goals of this study are to determine:
The vaccines being tested in this study CANNOT cause HIV infection or AIDS. They are not made from live HIV, killed HIV, parts taken from HIV, or HIV-infected human cells. They are made from synthetic (laboratory-made) copies of HIV pieces and therefore cannot cause HIV infection or AIDS.
The study vaccines are investigational. This means they are not approved for general use but are under investigation in clinical trials regarding its safety and efficacy. We do not know whether the vaccine regimen will be safe to use in people, or whether it will work to prevent HIV infection.
The study vaccine regimen is only used for research. It is not available to the public or for sale. The vaccines are supplied by their manufacturer, Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, for use in this study.
We can give you more detailed information about the study vaccines, if you would like.
Currently, the Ad26 vaccine in combination with one of the protein vaccines are being tested in female participants in southern Africa. That study is called Imbokodo, and also known as HVTN 705/HPX2008. More than 2600 participants are taking part in this study to show if the vaccines can prevent HIV infection in women from southern Africa. This study is monitored by an independent body called "Data Safety Monitoring Board" and so far it was recommended to continue the study as it is.
The investigational vaccine regimen used in Mosaico differs slightly from the regimen in Imbokodo with the addition of a second component in the protein vaccine. The hope is that this additional protein will help the vaccine regimen work in other regions of the world where the Clade B strain of HIV is found (Southern Africa has Clade C).
The vaccines that will be used in Mosaico have been utilized in humans in several other trials: “Approach”, “Ascent”, “Traverse” and “Imbokodo”. These trials have been conducted in the US, Rwanda, Uganda, Kenya, South Africa, Mozambique, Malawi, Zambia, Zimbabwe and Thailand, using either the same vaccination regimen, or similar ones. To date, more than 3000 individuals have enrolled in these clinical trials. Approximately 2000 individuals were vaccinated at least once with the Ad26 component, of which approximately 1500 received the same Ad26 component that is being used in Mosaico. And more than 1500 have been vaccinated at least once with the protein component, of which 93 received the same protein component that is being used in Mosaico. Early results from Approach, Traverse and Ascent have shown there are no serious health problems related to these vaccines, and that these vaccines produce immune responses. (We do not yet have data from the Imbokodo study.) Over 200 participants in these trials are currently enrolled in long term follow up which will continue evaluating vaccine responses for an additional 3 to 5 years. It is important to note that there is always the possibility that problems may yet arise. One purpose of the Mosaico study is to test whether the vaccines are safe when given to more people. Each participant’s health will be watched closely throughout the study.
The Mosaico and Imbokodo studies differ from some of the earlier studies in that researchers are now looking to learn if this particular vaccine regimen can prevent HIV infection.
The study is being conducted by the HVTN, Janssen Vaccines & Prevention B.V., NIAID, USAMRDC, and all the participating study clinics. These partners are working in collaboration with community stakeholders to ensure this research is acceptable to the local communities and respectful of local cultures.