Vaccine targeting latent TB enters clinical testing

December 1, 2011, Aeras

Statens Serum Institut and Aeras today announce the initiation of the first Phase I clinical trial of a new candidate TB vaccine designed to protect people latently infected with TB from developing active TB disease. The trial is being conducted by the South African Tuberculosis Vaccine Initiative (SATVI) at its field site in Worcester, in the Western Cape province of South Africa. Dr. Hassan Mahomed is the principal investigator.

"Two billion men, women and children live with ," said Jim Connolly, President and of Aeras. "It's daunting to comprehend that there is a vast reservoir of people with a 5-10% of becoming sick with TB. A vaccine that prevents in this population could save millions of lives, and this trial is a first step in assessing a designed for this purpose."

The candidate (SSI H56-IC31) is a subunit vaccine containing recombinant TB proteins formulated in a proprietary adjuvant IC31® from Intercell. It is being developed under a consortium of researchers led by Peter Andersen at the Statens Serum Institut (SSI) based in Copenhagen. The consortium is supported as part of the Grand Challenges in Global Health, an initiative that fosters scientific breakthroughs needed to prevent, treat and cure diseases of the developing world.

"The development of urgently needed new TB vaccines requires a global effort," said Prof. Peter Andersen, the Vice President of Vaccine Research & Development at SSI. "The advancement of this candidate from an idea to the clinic working in collaboration first with the Grand Challenges consortium and now with Aeras and SATVI is an important and exciting milestone for all the researchers involved."

This clinical trial will be the first to test this vaccine candidate in people. It will assess the safety and immunogenicity of SSI H56-IC31 in 25 adults, including participants with and without latent TB infection. SSI H56-IC31 has been tested in several pre-clinical studies with no safety concerns and has shown efficacy in small animal models administered both before infection and to latently infected animals. The vaccine was also shown to control clinical disease and reactivation in a non-human primate model. This is the first time a South African research institute has led a first-in-human Phase I clinical trial of a new TB vaccine.

"SATVI is delighted to be part of the trial at this early stage, which is testament to the high-regard that the developers have for our TB vaccine clinical research expertise to conduct these crucial early trials in humans," said SATVI Director, Professor Willem Hanekom.

SSI H56-IC31 is being developed for both adolescent and adult populations. The trial has been approved by the Medicines Control Council of South Africa. Preliminary results of this trial are expected at the end of 2012.

Explore further: Final child vaccinated in clinical trial of new TB vaccine

Related Stories

Final child vaccinated in clinical trial of new TB vaccine

May 4, 2011
The final participant in a clinical trial to assess the safety and efficacy of a new vaccine against tuberculosis (TB) has been vaccinated.

2,784 vaccinations later

April 29, 2011
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 ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.