Results of an early-stage clinical trial of an HIV vaccine could mean a hoped-for breakthrough in the battle against AIDS.
It was in 1981 that the Centers for Disease Control and Prevention (CDC) first reported on a rare lung infection in a young, healthy man who was gay. In 1982, the term "Acquired Immune Deficiency Syndrome (AIDS)" was used for the first time. Since then, the World Health Organization reports that HIV has infected 70 million people, and the deadly syndrome AIDS the virus causes has killed 35 million. The tragic timeline of this disease will continue until there is a way to prevent its spread.
Although research has made significant strides in developing treatments to limit the symptoms, death sentence, and transmission of HIV, it remains within the bodies of those infected, capable of infecting still more. Despite several attempts over the decades, a safe, effective vaccine against HIV has remained out of reach.
Dan Barouch, a researcher at the frontlines of the war against HIV, said in a post on the Johnson & Johnson website: "The HIV epidemic is clearly one of the defining global health problems of our time. We want to do everything in our power to help find a solution to this disease."
In a presentation at the 9th International AIDS Society Conference on HIV Science held in Paris today, researchers discussed the results of their study, called APPROACH.
According to the National Institute of Allergy and Infectious Diseases (NIAID), almost 37 million people around the globe live with HIV. Closer to home in the US, 1.2 million have the disease and 13% are not yet aware they are infected. NIAID supports research in HIV through its laboratories and its support of clinicians working toward the same aims.
One of the efforts supported by NIAID, through the HIV Vaccine Trials Network, is the APPROACH study, which is also sponsored by Janssen Pharmaceutical Companies of Johnson and Johnson.
A study of vaccine efficacy in almost 400 volunteers in the US, Uganda, South Africa, Rwanda, and Thailand, APPROACH researchers randomly assigned each participant to one of seven experimental vaccines — or a placebo — a compound that has no medicinal or other impacts.
Some of the experimental vaccines developed in the APPROACH effort are intended to trigger immune system response to several subtypes of HIV. Because of their ability to induce a healthy immune response to multiple strains of HIV, they are called "mosaic" type vaccines.
The vaccine regimen in the APPROACH study involved:
- Four vaccinations over 48 weeks
- Two initial doses, with two booster vaccines
- The mosaic vaccine with the best results contains a version of the virus that causes the common cold engineered not to cause illness. The virus was then combined with three antigens, substances that cause the immune system to respond to their presence.
Different mosaic-type vaccines did well in the early trial, triggering an anti-HIV immune response in healthy, HIV-negative adults. Based on its positive earlier performance in animal studies involving monkeys, and in this early-stage human study, researchers are hoping to evaluate further the vaccine that elicited the strongest immune response. The vaccine is named "Ad26.Mos.HIV."
Planned for late 2017, or the early months of 2018, scientists plan to enroll 2,600 HIV-negative, healthy women to study the vaccine response in an at-risk population. In a press release, Barouch said, "the promising, early-stage results from the APPROACH study support further evaluation of these candidate vaccines to assess their ability to protect those at risk of acquiring HIV."
Later this year, the results from a parallel early-stage clinical trial named TRAVERSE will be rolled into the decision to move forward with the larger South African study. The TRAVERSE study is comparing mosaic vaccines containing slightly different antigens, with results expected toward the end of the year.
The battle against HIV and AIDS continues through the courage, funding, and knowledge of individuals and teams throughout the world. Let's hope this one is a winner.