2,784 black babies tested with new TB vaccine

2,784 non-white babies from the poorest Cape Town communities hold the key to finding a new TB vaccine – but could these babies really give their ‘ informed consent ’ as ethics rules demand?

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Experimental TB inoculation trials now enter phase two in Cape Town
  2011-04-29  Worcester,  Cape Town.  – Baby Leroy Muller sat on his mom Sarie’s lap while receiving the last innoculation in the trials to find a new vaccine for Tuberculosis today. He was the 2,784th baby to be given the experimental vaccine under the South African Tuberculosis Vaccine Initiative. (source story: Elsabé Brits, pictures: SATVI).

The research was launched in July 2009 under the auspices of the Institute for Infectuous Diseases and Molecular Medicine at Cape Town University medical school. Innoculation-manager Dr Michele Tameris said that while the innoculation test-phase (one) now has been completed, the babies will be monitored until April next year. Half of the babies were given the vaccine – the others a placebo. Tameris said that ‘if the new vaccine is proven to be effective, the next phase will start involving 25,000 people worldwide.’

  Babies from the poorest Afrikaans-speaking populations in the towns of Worcester,  Robertson, De Doorns, Touwsriver, Montagu, Ashton, Bonnievale, McGregor, Wolseley, Tulbagh, Prince Alfred Hamlet, Rawsonville, Villiersdorp and Ceres participate in the trials. This region is known for its very high prevalence of Tuberculosis – among the world’s highest.

Ms Brits interviewed parent Francis Gordon of Ceres, who was there with baby Connor on the last day of the innoculation-stage . She said ’  it is a good thing to participate.’ And baby Hanico Spannenberg’s mom said he’s not really aware of anything other that ‘at this stage of his life he is just eating, drinking and crying.”
http://www.dieburger.com/Suid-Afrika/Nuus/Laaste-baba-in-nuwe-TB-projek-ingeent-20110429

Quotes on the SATVI website:

“Quite simply put, we are trying to ascertain why some of the babies, despite having been vaccinated at birth, still develop TB. We are part of the war against TB.’  Ben Kagina, PhD student http://www.satvi.uct.ac.za/

“SATVI is committed to high ethical standards necessary for conducting research involving human participants. We ensure that the safety of study participants comes first, and make sure that all are well informed of their rights before, during and after trials. A dedicated Regulatory Affairs team ensures we comply with local, national and international standards. In addition, all personnel receive rigorous training in Good Clinical Practice (GCP) and/or Good Laboratory Practice (GLP), which includes consenting of and appropriate communication with study participants. Our activities are overseen by the University of Cape Town’s Faculty of Health Sciences Human Research Ethics Committee, which complies with regulatory frameworks nationally and internationally.