TD Vaccines A/S Announces Promising Phase I results for ACE527 to combat Bacterial Diarrhoea
TD Vaccines A/S announced promising preliminary Phase I trial results for ACE527, a live, 3-strain, oral ETEC (Enterotoxigenic E Coli) vaccine to combat a leading cause of bacterial diarrhoea that afflicts millions of international travellers as well as children in the developing world.
In the Phase I trial, involving 36 adult volunteers (12 placebo; 12 on low dose and 12 on high dose vaccine), ACE527 was very well tolerated, demonstrated a strong safety profile and showed promising initial immunological data. The project will now proceed to a Phase II challenge study with Clinical Proof of Concept anticipated by the year end.
ACE527 is a live, whole-cell ETEC vaccine which is novel because it comprises three attenuated ETEC strains and induces both colonisation factor and toxin specific immune responses. The Phase I study showed a mucosal immune response to colonisation factors on all three strains and confirmed that the vaccine generates a strong mucosal and systemic anti-toxin response as well. The trial was conducted at the Center for Immunization Research at Johns Hopkins University, Baltimore, Maryland, US, where the Phase II trial will also take place.
The Phase II trial aims to recruit 72 subjects (36 will receive vaccine and 36 placebo) of whom 56 will be challenged with a virulent strain of ETEC (28 subjects each having received vaccine or placebo). The trial is scheduled to start in the second quarter of 2010.
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