Published: September 12, 2011
By DENISE GRADY
PHILADELPHIA — A year ago, when chemotherapy stopped working against his leukemia, William Ludwig signed up to be the first patient treated in a bold experiment at the University of Pennsylvania. Mr. Ludwig, then 65, a retired corrections officer from Bridgeton, N.J., felt his life draining away and thought he had nothing to lose.
Doctors removed a billion of his T-cells — a type of white blood cell that fights viruses and tumors — and gave them new genes that would program the cells to attack his cancer. Then the altered cells were dripped back into Mr. Ludwig’s veins.
At first, nothing happened. But after 10 days, hell broke loose in his hospital room. He began shaking with chills. His temperature shot up. His blood pressure shot down. He became so ill that doctors moved him into intensive care and warned that he might die. His family gathered at the hospital, fearing the worst.
A few weeks later, the fevers were gone. And so was the leukemia.
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Spanish researchers have completed the first human trial of a new vaccine against HIV. It has been successful in 90% of the HIV-free volunteers during phase I testing. This vaccine brings great hope to eradicate this plague forever.
The team lead by Dr Mariano Esteban, a researcher at the Spanish National Research Council’s Biotechnology National Centre, has been working on this method since 1999. They are using an attenuated virus called the MVA-B, a variation of the Modified Ankara Vaccinia, which was previously used to eradicate smallpox. The Modified Ankara Vaccinia also forms the base of other vaccines. The B refers to the HIV-B, the most common HIV subtype in Europe.
Dr Esteban’s team inserted the HIV genes Gag, Pol, Nef and Env in MVA’s genetic sequence. In 2008, they tried the resulting HIV nuke on mice and monkeys. It was a complete success.
Successful human test
The first human test results were published in Vaccine and Journal of Virology. In the experiment, scientists injected the vaccine in 24 of 30 HIV-free volunteers. Six volunteers were treated with a placebo vaccine—they didn’t experience any effect. But 90% of the treated subjects developed a very strong immunological response against the HIV virus. 85% kept the immunological reaction for at least one year, which is really good news.
According to their results, there were no significant secondary effects in any of the patients, which was one of the major objectives of to be tested in this clinical trial.
Despite the success, Dr Esteban is cautious:
[T]he treatment has only been tested on 30 volunteers and, while [the vaccine] provokes a powerful response in most of the cases, it’s still to soon if the resulting defense would be effective against an actual [HIV] infection.
The team will now start another phase I trial, injecting the vaccine in HIV-infected people. The objective of this trial is to test the therapeutical effect of the vaccine in these patients.
According to Dr Esteban, “in principle, the immunological profile of MVA-B satisfies the requirements for a promising vaccine against the HIV, like the creation of antibodies and the activation of key cells in the defense against the virus.” Sadly, it is still far away from commercialization: they need to test this on phase II and III trials, injecting vaccinated volunteers with the actual HIV virus on a larger scale.
Hopefully, one day this one will nail that HIV bastard down. [CSIC—In Spanish]
