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Tat vaccine acts in synergy with HAART
Ensoli B. PLoS ONE.2010;5;e13540.
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Patients with HIV taking highly active antiretroviral therapy are more likely to recover immune functions after receiving the Tat vaccine, according to results from an interim analysis published in PLoS ONE.
“We believe that this vaccine strategy may indeed represent an effective tool to significantly increase the efficacy of HAART and to prevent those clinical manifestations of HIV/AIDS, which are still present even under effective therapy,” Barbara Ensoli, MD, PhD, of the National AIDS Center, told Infectious Disease News. “In addition, and based on the indications emerging from the incoming results, additional parameters will be assessed to further explore the effects of vaccination on both the virologic and immunologic endpoints.”
Although HAART is known to be a successful virus-targeting intervention against HIV, it does not always restore immune homeostasis and can only partially reduce chronic immune activation, according to background information in the study. More recently, Tat vaccination has been found to have important effects on the virus and the immune system.
Therefore, Ensoli and colleagues hypothesized that Tat vaccination would be essential for disease maintenance in patients treated with antiretroviral drugs.
The phase 2 study consists of 87 virologically-suppressed HAART-treated patients also vaccinated with the Tat vaccine (ISS T-002). Researchers compared these patients with 32 virologically-suppressed HAART-treated, un-vaccinated patients included in a parallel, prospective, observational study.
Tat vaccination was administered in three or five intradermal monthly administrations of either 7.5 mg or 30 mg. The researchers noted positive results and therefore conducted an interim analysis 48 weeks into the study.
Improvements were observed in patients vaccinated with Tat (P<.05). Vaccinated patients showed an increase in both CD4+ B and CD4+ T cells, significant recovery of immune functions including an increase of regulatory and memory T cells, and significant improvements in peripheral blood mononuclear cell viability.
According to the researchers, Tat vaccination increases the efficacy of HAART, restores immune homeostasis, and the vaccine controls virus replication in at-risk patients by preventing the spread of the virus and by slowing the progression from HIV to AIDS.
“We are now in the process of completing enrolment of the 160 patients foreseen by the amended study protocol and completing the follow-up of those that have already received the vaccination in order to monitor the persistence of the anti-Tat immune responses and to determine for how long the beneficial effects of vaccination will last,” Ensoli said. — by Ashley DeNyse
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