Crucell, Harvard to Take Part in Experimental AIDS Vaccine Test in Africa

Dutch biopharmaceutical company Crucell NV has announced that a joint Phase I trial of an experimental AIDS vaccine will take place at sites in the United States and Africa. The trial will enroll healthy HIV-free adults to test a product that combines two adenovirus-based vaccines.

Individually, the candidates have proven safe; the new trial will test their safety in combination and their ability to provoke an immune response when administered in a prime-boost regimen, Crucell said. The vaccine is designed both to kill infected cells and prevent HIV from entering uninfected cells.

The vaccine combines the Ad35-ENV candidate, which underwent Phase I testing by the International AIDS Vaccine Initiative, and the AD26.ENVA.01, which underwent Phase I testing by Crucell and Harvard's Beth Israel Deaconess Medical Center. The adenovirus vectors chosen, Ad26 and Ad35, are types that occur less frequently in humans, Crucell said. "In contrast 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," Crucell said.

The Ragon Institute also is participating in the trial, which the Vaccine Initiative is leading.

"Our program to develop this combination vaccine represents one of the most advanced AIDS vaccine programs in the world," said Jaap Goudsmit, Crucell's chief scientific officer.

Crucell did not indicate when the trial will begin or how many people will be enrolled.

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