We were delighted to see that TB vaccine work received attention in your paper, including mentioning some of the work which we are involved in. We would, however, ask that you allow us to point out some small inaccuracies in the article.
Dear Editor,
Regarding the October 19 "TB Vaccine in the pipeline" article
We were delighted to see that TB vaccine work received attention in your paper, including mentioning some of the work which we are involved in. We would, however, ask that you allow us to point out some small inaccuracies in the article.
You stated in the article that this is the first time in 80 years that a new TB vaccine has entered the efficacy stage of a clinical trial. There have been other efficacy trials of new TB vaccines conducted before the current MVA85A/AERAS485 trial was started, e.g. a Phase III trial of Mycobacteriam vaccae conducted in Dar es Salaam, Tanzania, and reported at the IUATLD TB meeting in Paris in 2008, the so called "Dar Dar" trial.
The MVA85A/AERAS485 vaccine candidate was developed by Dr. Helen McShane and others at Oxford University, United Kingdom, and is now being developed by a consortium which includes The Oxford- Emergent Tuberculosis Consortium Ltd (OETC) and the Aeras Global TB Vaccine Foundation.
The South African Tuberculosis Vaccine Initiative (SATVI) is a research group, located within the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town. The clinical trial site where SATVI conducts TB vaccine trials in and around Worcester, a rural town about an hour's drive from Cape Town and it is SATVI who are conducting the Phase IIb clinical trial of MVA85A/AERAS485 referred to.
The efficacy of any new vaccine candidate will have to be tested in one or more Phase III trials. We will not know whether any new vaccine candidate is efficacious until it has gone through such a clinical trial.
Phase III trials are not the final phase, but they are the phase on which licensure is usually based. As stated in your article, a Phase III trial involves a larger number of volunteers and the trial population is normally divided into groups with one group receiving the vaccine and the other not.
Aeras aims to make the new viral vectored or recombinant protein TB vaccines available at around 1-2$ per dose.
Please let me know if you require further clarification. Once again, thank you for highlighting this area of research and need.
Sincerely,
Dr Tony Hawkridge
Head of Africa Office
Aeras Global TB Vaccine Foundation
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