Dutch biopharmaceutical company 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."

Crucell N.V. is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases.

AdVac technology is a vaccine technology developed by Crucell. It is considered to play an important role in the fight against emerging and re-emerging infectious diseases, and in biodefense. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system. Most vectors are based on an adenovirus, such as the virus that causes the common cold. The AdVac technology is specifically designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac technology is based on adenoviruses that occur less frequently in the human population, such as Ad26 and Ad35. In contrast to, for instance, Ad35 antibodies, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines. All vaccine candidates based on AdVac are produced using Crucell's PER.C6 production technology.

IAVI's core mission is to support in every way the development of preventive AIDS vaccines that are not only safe and effective, but also accessible to all people.

BIDMC is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks in the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Care Center.