What Is Imbokodo?
Imbokodo is a large efficacy study testing a combination of two experimental vaccines to prevent HIV. The study vaccines are called Ad26.Mos4.HIV (Ad26 vaccine) and Clade C gp140 (protein vaccine). The main goals of this study are to determine:
- Can the vaccines prevent HIV infection?
- Are the vaccines safe to give to people?
- Do people’s immune systems respond to the study vaccines?
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 (man-made) copies of HIV pieces and therefore cannot cause HIV infection or AIDS.
These study vaccines are experimental. This means we are still researching them and continuing to learn about how safe they are to use in people and if they will prevent HIV infection.
These vaccines are only used for research. They are not available to the public or available for sale. These vaccines are supplied by their manufacturer, Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Tell Me More About Imbokodo
Imbokodo is a large study that aims to prove that these vaccines can protect women in sub-Saharan Africa from HIV infection. If Imbokodo can show that these vaccines work in women in sub-Saharan Africa, it will be a very important step on the way to finding a safe and effective vaccine that will protect people around the world from HIV.
Another large study, conducted in 2009, showed for the first time that a vaccine could prevent HIV, although only modestly. That study was called RV144 and was done in Thailand with over 16,000 people. The results were exciting, and showed the vaccine prevented 31.2 percent of new HIV infections. This means the study vaccines used in RV144 were able to prevent HIV infection in approximately one in three people who got the vaccine in the study. Although this was not enough to have the vaccines licensed for public use, the study provided scientists with the signs and information they needed to develop better vaccines. The vaccines being tested in Imbokodo are different from the ones in the RV144 trial.
The vaccines being used in Imbokodo, and similar vaccines, have been tested in several smaller studies. One of these smaller studies is known as Approach, which uses a very similar Ad26 vaccine and the same protein vaccine as Imbokodo and is being conducted in the US, Rwanda, Uganda, South Africa, and Thailand. The Ad26 and protein vaccines used in Imbokodo are also being given to 235 people in two studies in the US, Kenya, and Rwanda called HVTN 117 (Traverse) and HVTN 118 (Ascent). Traverse and Ascent are early phase trials in which researchers want to learn if the Ad26 and protein vaccines (the same vaccines used in Imbokodo) are safe to give to people; if people are able to take the study vaccines without becoming too uncomfortable; and how people’s immune systems respond to the Ad26 and protein study vaccines. Early results from Traverse, and from the Approach study mentioned above, have shown these vaccines are safe to give to people and provided good immune responses.
In studies conducted to date, there have been no serious health problems related to these vaccines. However, there is always the possibility of problems that have not been seen yet. That is why one purpose of this 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.
Imbokodo differs from the smaller studies in that, in Imbokodo, researchers are now looking to learn if the Ad26 and protein vaccines can actually prevent HIV infection.
Who Is Doing The Study?
The study is being conducted by the HVTN, Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and all the participating study clinics. These partners are working in collaboration with community stakeholders to ensure this research is acceptable to the local community and respectful of local cultures.