Big news emerges from the local medical community as the National Institute of Health announces that there will be no further immunization injections in the “Hope Takes Action” aka HVTN 505 study.
“The [immunizations] were not stopped because of any safety concern,” Vanderbilt University’s Principal Investigator Dr. Spyros Kalams revealed. “[They were] stopped because it met the criteria for futility. The way you do these studies, you have your criteria for success and if you don’t meet those you stop the trial.” The HVTN 505 study goals were to attain a 50 percent decrease in infections.
In a letter obtained by O&AN to HVTN 505 participants, the Data Safety Monitoring Board (DSMB) decided to discontinue the study after they concluded that “the vaccine did not prevent HIV infection.” The DSMB also concluded that the “vaccine did not reduce the viral load in those who became infected with HIV.”
Additionally it was reported that 48 infections occurred with 21 occurring in the placebo group and 27 in the vaccine group. With more than 2,500 national participants enrolling in the HVTN 505 study, Dr. Kalams stressed that these infections were no statistically significant.
Josh Robbins, a HVTN 505 study participant and O&AN consultant, was one of those infected but stressed the importance of the work done by the Vanderbilt HIV Vaccine Trial staff.
“This HIV vaccine trial process is important,” Robbins shared exclusively. “Discovering what doesn't work leads us to being able to discover what might work. This is not a failure. This is a finding, which also provided risk reduction counseling, increased HIV testing and education to the demographic with the highest statistical risk of new infections.”
“HIV research is important. It is a blessing to have the Vanderbilt HIV Vaccine unit here. As one of the 48 infected during the trial, it is important to remember that the vaccine didn't cause my infection. I was exposed to HIV during sexual contact with someone unknowingly HIV positive. I'm proud of today's finding, as I believe it leads us one step closer to discovering, thru biomedical research, an effective preventive HIV vaccination."
Vanderbilt University is just one of many medical centers taking place in the national study and while they enrolled 124 participants from Tennessee in the current study, the cumulative count for Tennessee participants in Vanderbilt’s clinical trials is over 1,000.
Dr. Kalams reported that the announcement would not have any immediate impact of Vanderbilt University’s vaccine trials. He also acknowledged that they had no immediate plans for another vaccine trial. However, Dr. Kalams stated that further trials will probably not use the adenovirus shell for the vaccine.
While participants will no longer be accepted for this study, Dr. Kalams urges current participants to stay involved and continue with study visits for HIV testing and monitoring.
“We’re gathering a lot of information from this study,” Dr. Kalams said. “For instance, what kind of immune responses we generated with this vaccine. There might be some subtle effects of the vaccine we can only figure out when we go back and thoroughly look at all the data. This is just a snapshot that what we’re running on right now. There’s a lot of information that will be coming up over the next year or two.”
Read the official press release from the National Institute of Health here.