The Phase I trial is the first ever to test a rAAV-based vaccine and is primarily designed to evaluate safety and tolerability of the vaccine at escalating dose levels. The study is also designed to evaluate immune responses following vaccination. No safety concerns were identified and the vaccine was well tolerated. In addition, a single administration of the vaccine at the doses evaluated in this initial study did not elicit significant immune responses.
The favorable tolerability data from this trial are consistent with our growing clinical experience with AAV and now position us to continue the clinical development of this vaccine program. We can begin to evaluate higher dose levels and repeat administration of this vaccine, says H. Stewart Parker, president and CEO of Targeted Genetics. In addition, our comprehensive development strategy for this AIDS vaccine includes the development of an AAV1-based vaccine, as well as a multi-component approach involving multiple HIV antigens. We are also examining in preclinical studies the use of AAV vaccines in a prime boost approach, to potentially increase immune responses to the HIV antigens further. In short, we continue to be optimistic about the potential of AAV-based vaccines against HIV/AIDS.
The Phase I clinical trial is a double-blind, placebo-controlled, dose-escalation safety study that also monitors immune responses to the product candidate. The portion of the study conducted in Belgium and Germany enrolled 50 volunteers who were in good general health and not infected with HIV. Each volunteer received a single intramuscular injection into the upper arm. The portion of the trial being conducted in India will enroll 30 healthy HIV-negative volunteers. A subset of volunteers also will receive a second dose of the vaccine to determine if repeat dosing is safe, and if it increases immune responses.
The phase I trial for tgAAC09 is being studied in collaboration with the not-for-profit International AIDS Vaccine Initiative and researchers at Columbus Childrens Research Institute and The Childrens Hospital of Philadelphia.
Source: Targeted Genetics