2,784 vaccinations later

By Jonathan Wood
Mothers and babies taking part in the trial in South Africa.

The two thousand, seven hundred and eighty-fourth baby has been vaccinated today in South Africa as part of a clinical trial of a new vaccine against tuberculosis. The new TB vaccine is the most advanced in development anywhere in the world.

That’s the last baby in the trial, and marks completion of trial enrolment almost two years to the day after the study was first announced.

"We are extremely proud of this achievement and are eager to see the study results, which are expected to be available in 2012," says Dr. Helen McShane, who developed the at the Jenner Institute, Oxford University. "This milestone brings us a step closer to potentially having a new , from which millions of people around the world would benefit."

It’s certainly quite a milestone, and marks a great deal of work to vaccinate all these babies under 1 year old in an area where there is one of the highest rates of TB in the world.

But why precisely 2,784 babies, not 2,500 or 3,000?

Helen explains that it is entirely down to the calculations used to plan the trial. These sums showed that 2784 babies should give enough statistical weight to be able to see a significant improvement in preventing TB over the 90-year-old (but still standard) BCG jab.

The new vaccine is designed to be given to infants after they have received the BCG vaccine, boosting the immune response further. All the babies in the trial have received the BCG vaccine, with half then getting the trial vaccine and half a placebo. "If successful, the next steps would be to plan a phase III trial and licensure of the vaccine," Helen says.

The current trial was a phase IIb trial, and is the first to be able to really determine whether the vaccine gives infants any protection against TB. A larger phase III trial would pin down exactly the size of any benefit and guide how the vaccine could be rolled out.

The trial in Worcester, about 100km from Cape Town, is being conducted by the University of Cape Town’s South African Vaccine Initiative (SATVI), in partnership with Aeras, the Wellcome Trust, and the Oxford-Emergent Tuberculosis Consortium Ltd (a joint venture between the University of Oxford and Emergent Biosolutions Inc formed to develop the vaccine)

"We are pleased to report that the trial has run smoothly to date," says Dr. Hassan Mahomed, who has led the trial at SATVI.

add to favorites email to friend print save as pdf

Related Stories

TB vaccine enters new clinical trials

Apr 23, 2009

(PhysOrg.com) -- The world’s leading candidate for a tuberculosis vaccine, developed at the University of Oxford, is to enter Phase IIb proof-of-concept clinical trials, making it the first TB candidate ...

New TB booster shows promise

Mar 16, 2010

A booster shot appears to improve tuberculosis (TB) resistance in previously vaccinated adults, according to new research in South Africa.

Tuberculosis vaccine passes phase I trial

Mar 24, 2011

(PhysOrg.com) -- The currently available tuberculosis vaccine BCG is over 90 years old – and its effectiveness is declining. An increasing number of mycobacterial strains are emerging, against which the ...

New TB vaccine enters clinical testing

Sep 23, 2010

At an international gathering of TB vaccine researchers in Tallinn today, the Aeras Global TB Vaccine Foundation announced it will initiate a clinical trial of an investigational live recombinant tuberculosis vaccine to be ...

Trials begin for 'essential' new TB vaccine

Jul 30, 2007

Clinical trials are underway with the first new vaccine against TB in over 80 years. If successful, the tests will have major implications for TB control and could lead to the development of a new vaccine ...

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

User comments