Date: 2014-03-11
Type of information:
phase: 2
Announcement: initiation of the study
Company: Aeras (USA)
Product: H4+IC31® (AERAS-404)
Action
mechanism: H4 + IC31 is a novel vaccine candidate developed jointly by Aeras, Statens Serum Institut (SSI) and Sanofi Pasteur. It uses SSI\'s H4 antigen (a fusion protein of M.tuberculosis antigens 85B and TB10.4), combined with the biotech company Valneva\'s IC31®adjuvant to stimulate T cell-mediated immunity. The vaccine candidate has been shown to be immunogenic and protective before and after TB exposure in preclinical animal models. It has already been tested in four Phase I studies—including one in South Africa—in adults, which showed an acceptable safety profile and immunogenicity.
Disease: tuberculosis
Therapeutic area: Infectious diseases
Country: South Africa
Trial
details: The randomized, placebo-controlled, partially blinded trial will enroll 990 adolescents in the Western Cape Province. The South African Tuberculosis Vaccine Initiative (SATVI) will conduct this Phase II trial in healthy adolescents who have been previously vaccinated with BCG as infants. One-third of the participants will receive a revaccination with BCG; one-third will receive vaccination with H4+ IC31®, and one-third will receive a placebo. Infection will be determined with the use of commercially available interferon gamma release assays.
Latest
news: * On March 11, 2014, Aeras has announced the initiation of the first randomized, controlled tuberculosis (TB) vaccine trial designed to study prevention of Mycobacterium tuberculosis (Mtb) infection by vaccination. The Phase II study of the TB vaccine candidate, H4+IC31® (AERAS-404), will evaluate its safety, immunogenicity, and ability to prevent infection by Mtb. The trial, which will be conducted in South Africa, will also evaluate BCG revaccination.This novel trial design establishes a potential new paradigm in TB vaccine development. Clinical development of TB vaccines is hampered by the lack of biologic correlates of protection and lack of validated preclinical models, which could provide evidence of likely efficacy in early stages of development. The prevention of infection trial design enables a smaller, faster proof of concept to help in deciding on advancement into large-scale disease-prevention trials. While a TB vaccine would not need to prevent infection with Mtb to prevent TB disease, prevention of infection with Mtb would be an important marker of biologic impact. Preliminary results are expected at the end of 2015. If this initial study in adolescents shows that revaccination with BCG or vaccination with H4+ IC31® prevents infection with Mtb, then additional larger scale efficacy studies looking at the impact on TB disease in more diverse populations would be warranted. The trial is approved by the Medicines Control Council of South Africa.
