Crucell and Harvard (BIDMC) Join Forces with IAVI to Advance AdVac-based AIDS Vaccine

12-Aug-2010 - Netherlands

Crucell N.V. announces its intention to participate in an international Phase I clinical trial in the United States and Africa of a combination of two AdVac®-based AIDS vaccine candidates, Ad26.ENVA.01 and Ad35-ENV, in healthy adults who are not infected with HIV. The clinical trial, which will be led by the International AIDS Vaccine Initiative (IAVI), represents a collaboration between IAVI, Crucell, the Ragon Institute, and Beth Israel Deaconess Medical Center (BIDMC), a major teaching hospital of Harvard Medical School.

The Ad26.ENVA.01 vaccine candidate used in this study is manufactured by Crucell, while the Ad35-ENV vaccine is developed by IAVI. Both vaccines candidates are based on Crucell's proprietary AdVac® technology. The planned Phase 1 trial of the vaccine combination, which follows a Phase I trial of the Ad35-ENV vaccine by IAVI and a Phase I trial of Ad26.ENVA.01 by the Harvard-Crucell consortium, supported by the National Institute of Allergy and Infectious Diseases (NIAID), represents a key step towards proof of concept studies to evaluate the efficacy of the vaccine combination in humans.

The Phase I trial is designed to test two AIDS vaccine candidates in a prime-boost combination in HIV-uninfected healthy adult volunteers. The objectives are to evaluate the safety of the candidate vaccines Ad26.ENVA.01 and Ad35-ENV and their ability to provoke an immune response when administered in a prime-boost regimen.

"We are very happy that IAVI has decided to support the NIAID-sponsored Crucell-Harvard AIDS vaccine program, making it possible to advance this vaccine candidate further towards proof of concept Phase IIb efficacy trials in humans," said Jaap Goudsmit, Chief Scientific Officer at Crucell. "A different prime-boost AIDS vaccine approach has been shown in the RV144 trial (Thai Trial) to protect against HIV in humans, for the first time in the history of AIDS vaccine development. Our program to develop this combination vaccine represents one of the most advanced AIDS vaccine programs in the world and is based on the best science available today. We have the obligation as vaccine producers to do everything in our power to bring an effective AIDS vaccine to all people in need."

https://www.bionity.com/en/news/121420/crucell-and-harvard-bidmc-join-forces-with-iavi-to-advance-advac-based-aids-vaccine.html