NIH Initiates Phase 1 Safety Study of AVANT's Oral Combined Enterotoxigenic E. coli-Cholera Vaccine
Wednesday June 4, 8:00 am ET
First Clinical Study of Innovative Combination Vaccine
NEEDHAM, Mass.--(BUSINESS WIRE)--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) today announced that the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), has initiated a Phase 1 safety study of AVANT’s investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli (ETEC) and cholera. ETEC infection is a major cause of travelers’ diarrhea.
The study, a randomized double-blind, placebo-controlled, in-patient Phase 1 trial conducted in up to 64 adult volunteers, will examine the safety and immunogenicity of a single dose of the ETEC-Cholera vaccine, designated Peru-15 pCTB, at up to four escalating dose levels compared against placebo. The Principal Investigator, Dr. Mitchell B. Cohen, M.D., will conduct the study at the Cincinnati Children’s Hospital Medical Center.
“We are very pleased that NIAID has chosen to fund this initial study of our combination ETEC-cholera vaccine,” said Anthony S. Marucci, AVANT Immunotherapeutics Interim President and Chief Executive Officer. “This vaccine builds on the clinical successes to date of our single-dose, oral typhoid fever and cholera vaccines, and represents the next important milestone towards our goal of developing a safe, oral, rapid-acting “super enteric” vaccine that combines protection against multiple diseases in a single product.”
The Peru-15 pCTB vaccine is derived from the same cholera strain (Peru-15) as AVANT’s cholera vaccine, CholeraGarde®. CholeraGarde has been shown to be well tolerated and provide protective levels of immunity in studies involving over 400 vaccinees. The Peru-15 pCTB vaccine re-engineers the Peru-15 strain to produce additional, key antigens that provide protection against the ETEC bacterium, thus potentially adding protection against travelers’ diarrhea. Preclinical animal studies with the investigational combination vaccine have shown it to be highly immunogenic.
ETEC is a major cause of enteric disease among travelers, military personnel and those who live in developing countries where the disease is endemic. Market research studies conducted with travel medicine clinics have shown a strong preference for a combined vaccine compared to either ETEC or cholera vaccines given separately. |
