The Karolinska Institute has completed a 38-subject Phase I trial testing a prime-boost HIV vaccine regimen using three doses of unadjuvanted DNA vaccines over a three-month period followed by a single dose of a viral vector vaccine at nine months. The Karolinska Institute is currently conducting nonclinical safety studies to support a planned Phase I trial of a Vaxfectin-formulated HIV DNA vaccine as part of a prime-boost regimen.
The Vaxfectin adjuvant is intended to optimize the priming of immune responses and increase the performance of, or potentially even eliminate the need for, the viral vector vaccine boost. The Swedish Institute for Infectious Disease Control is sponsoring the development.
The SMI/Karolinska vaccines contain synthetic versions of genes encoding internal and surface proteins from different HIV subtypes. The combination is designed to provide protection against the most prevalent HIV strains circulating in Europe, Africa and the Americas.
In the first Phase I trial, the DNA priming vaccines were delivered with the Biojector 2000 needle-free injection system into either the muscle or the skin. In the next trial, the Vaxfectin-formulated DNA vaccines would be delivered with the Biojector 2000 needle-free injection system into the skin.
Eric Sandstrom, professor at the Karolinska Institute, said, “We hope to improve the breadth and magnitude of immune responses in the next clinical trial by using the Vaxfectin adjuvant with our DNA priming vaccine.”