News (Updated November 21, 2009)

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HIV vaccine failure probably caused by virus used, says new research

The trial, called 'STEP', was halted in September 2007 because preliminary results suggested that people who had been given the vaccine were more likely to be infected with HIV than people who had been given a placebo.

 (Media-Newswire.com) - The trial, called 'STEP', was halted in September 2007 because preliminary results suggested that people who had been given the vaccine were more likely to be infected with HIV than people who had been given a placebo.

The researchers behind today's study, from Imperial College London, King's College London and Royal Holloway, University of London , say their findings mean scientists may have to rethink other vaccines they are developing for diseases like HIV, tuberculosis and malaria, which are delivered in the same way, using the same virus 'shell'.

The vaccine used an adenovirus, which normally causes the common cold, to enable the vaccine therapy to travel around the body. Harmless HIV genes were then inserted into the virus. It was thought that this would help the immune system to learn to recognise and fight off HIV.

Today's study suggests that after receiving the trial vaccination, people who had previously built up immunity to the adenovirus had an influx of immune cells called CD4 T-cells homing in on their mucous membranes, as these cells prepared to fight off a new adenovirus infection. Mucous membranes are found in areas including the nose, mouth, vagina and gut. HIV naturally infects CD4 T-cells, so this inadvertently provided HIV with an abundance of potential new homes at the sites where the virus would naturally enter the body during sexual intercourse, thereby increasing people's risk of infection.

The researchers say their findings are a warning for scientists developing adenovirus vaccines against other diseases, as the same effect occurs with other, perhaps all, adenovirus subtypes.

Adenovirus infection is common and there are 51 known human strains. Around half of all adults in the developed world and about 90 percent of individuals in sub-Saharan Africa , where HIV is most prevalent, have built up immunity to the subtype of adenovirus used in STEP.

Today's findings may have implications for HIV, malaria and TB vaccines currently being developed
Preliminary results of the vaccine trial showed that people who had previously been infected with the adenovirus used in the trial had a significantly higher risk of being infected with HIV following the vaccine compared to people who were given a placebo.

Dr Steven Patterson, who is the corresponding author of the study from the Division of Investigative Science at Imperial College London, said: "HIV is a huge threat to global health, with 2.7 million people becoming infected every year. We were all hopeful that the STEP trial would be a success, so when the researchers published their results and the trial was halted, we were all very surprised and disappointed. Scientists use adenoviruses in all sorts of vaccines and we did not expect this result. It was vital to discover what caused this increase in HIV infection risk so we could avoid the same problem in future trials.

"Our research suggests that the adenovirus-based HIV vaccine effectively instructs the cells that HIV infects to gather round exactly where HIV is likely to be introduced. This is clearly worrying for this kind of vaccine. Scientists are currently developing adenovirus-based vaccines to protect people against TB and malaria as well as HIV, but they may have to rethink these vaccines if the effect we describe in our new paper is a problem for all of them," added Dr Patterson.

The researchers measured antibodies against adenovirus type 5 ( Ad-5 ) and adenovirus type 11 ( Ad-11 ) in 20 healthy volunteers to determine who had been infected. They then took samples of the volunteers' immune cells and grew them in the laboratory to see whether their CD4 cells would recognise Ad-5 and Ad-11. When the researchers added adenoviruses to the tissue cultures, they found that the viruses activated the CD4 cells and caused them to grow and replicate. They found that the newly generated CD4 cells had particular kinds of molecules on their surface that enabled them to migrate to mucosal membranes.

The results also showed that CD4 cells can recognise and react to another distinct subtype of adenovirus, regardless of which subtype the person was infected with initially. The authors say this means all subtypes of adenovirus are likely to be unsuitable in HIV vaccines.

 

Sexually spread diseases up, better testing cited

By MIKE STOBBE, AP Medical Writer Mike Stobbe, Ap Medical Writer

Nov 16, 2009

ATLANTA – Sexually spread diseases continue to rise, with reported chlamydia cases setting yet another record in 2008, government health officials said Monday.

Last year there were 1.2 million new cases of chlamydia, a sometimes symptomless infection that can lead to infertility in women. It was the most ever reported, up from the old record of 1.1 million cases in 2007.

Better screening is the most likely reason, said Dr. John M. Douglas Jr. of the U.S. Centers for Disease Control and Prevention.

Syphilis, on the verge of being eliminated in the United States about 10 years ago, also has been increasing lately. About 13,500 cases of the most contagious form of the disease were reported in 2008, up from about 11,500 the year before.

Unlike chlamydia, health officials think syphilis cases actually are increasing. Syphilis rates are up among both gay men and heterosexuals, said Douglas, director of the CDC's Division of STD Prevention.

Syphilis can kill if untreated, but chlamydia is not life-threatening. Neither is gonorrhea, which seams to have plateaued in recent years. Gonorrhea cases dropped to about 337,000 cases in 2008, down from about 356,000 cases.

Girls, ages 15 through 19, had the largest reported number of chlamydia and gonorrhea cases, accounting for more than one in four of those cases. But they're often screened more than other people, since 1993 federal recommendations that emphasize testing for sexually active women age 25 and under.

The government estimates there are roughly 19 million new cases of sexually transmitted disease annually. Experts say the most common is HPV, human papillomavirus, which can cause genital warts, cervical cancer and other cancers.

The government doesn't ask doctors to report every HPV case, but estimates the virus causes 6.2 million new cases each year. That is an old estimate, based on data from 2000, before a vaccine against some types of HPV came on the market in 2006.

The CDC estimates there are 1.6 million new cases of genital herpes each year, but that too is an old estimate for a non-reportable disease.

The agency also estimates there about 56,000 new cases of HIV each year.

 

Report: 20-somethings can go 2 years between Paps

By LAURAN NEERGAARD,AP Medical Writer - November 21, 2009

WASHINGTON – First mammograms. Now _ in an apparent coincidence _ Pap smears.

New guidelines by the American College of Obstetricians and Gynecologists say most women in their 20s can have a Pap smear every two years instead of annually to catch slow-growing cervical cancer.

The change comes amid a separate debate over when regular mammograms to detect breast cancer should begin, in the 40s or the 50s. The timing of the Pap guidelines is coincidence, said ACOG, which began reviewing its recommendations in late 2007 and published the update Friday in the journal Obstetrics & Gynecology.

While the two sets of recommendations are unrelated, they come at a time of intense debate over health-care reform. Mammograms in particular have drawn broad attention in Congress, reflecting a more than decade-long debate in the cancer community about how best to perform mammograms.

Republicans sought to connect the mammogram recommendations to the health-care overhaul, contending that such findings are the way that medical rationing starts.

Under the pending legislation, "nothing would prohibit the federal government from deciding if tests, treatments and procedures are too expensive, and therefore, unnecessary," Sens. Jon Kyl of Arizona, the Republican Whip, and Tom Coburn of Oklahoma, a physician, said in a joint statement.

But the Pap guidelines promise to be far less controversial as doctors for years have been told to perform fewer Paps among many women over 30, to cut back on unneeded care for the least at risk _ and there's growing understanding that over-treating younger women is an issue, too.

"The tradition of doing a Pap test every year has not been supported by recent scientific evidence," said Dr. Alan Waxman of the University of New Mexico , who headed ACOG's review.

The guidelines also say:

_Routine Paps should start at age 21. Previously, ACOG had urged a first Pap either within three years of first sexual intercourse or at age 21.

_Women 30 and older should wait three years between Paps once they've had three consecutive clear tests. Other national guidelines have long recommended the three-year interval; ACOG had previously backed a two- to three-year wait.

_Higher-risk women, such as those with HIV, other immune-weakening conditions or previous cervical abnormalities, need more frequent screening.

Paps can spot pre-cancerous changes in the cervix in time to prevent invasive cancer, and widespread use has halved cervical cancer rates in the U.S. in recent decades. About 11,270 new cases will be diagnosed this year, and about 4,070 women will die from it, according to American Cancer Society estimates. Half of women diagnosed with cervical cancer have never had a Pap, and another 10 percent haven't had one in five years.

Cervical cancer is caused by certain strains of the extremely common sexually transmitted virus called HPV, for human papillomavirus. There is a new HPV vaccine that should cut cervical cancer in the future; ACOG's guidelines say for now vaccinated women should follow the same Pap guidelines as the unvaccinated.

But the updated guidelines reflect better understanding of HPV. Infection is high among sexually active teens and young adults. Women's bodies very often fight off an HPV infection on their own without lasting harm, although it can take a year or two. The younger the woman, the more likely that HPV is going to be transient.

Moreover, ACOG cited studies showing no increased risk of cancer developing in women in their 20s if they extended Pap screening from every year to every two years.

As for adolescents, ACOG said cervical cancer in teens is rare _ one or two cases per million 15- to 19-year-olds _ while HPV-caused cervical abnormalities usually go away on their own. Treating them unnecessarily increases the girls' risk of premature labor years later, and preterm birth is a growing national problem.

 

US backs new start date for cervical cancer tests

Nov 20, 2009

WASHINGTON (AFP) - Women should not get their first cervical cancer screening before age 21, the leading US group of women's health care professionals said Friday, also recommending less frequent subsequent tests.

Pushing back the age of the first screening would help avoid giving teen girls unnecessary treatment, which can have "economic, emotional and future childbearing implications," according to the guidelines issued by the American College of Obstetricians and Gynecologists (ACOG).

ACOG previously recommended that cervical screening begin three years after first sexual intercourse or by age 21, whichever occurred first.

But the guidelines were revised because "screening for cervical cancer in adolescents only serves to increase their anxiety and has led to overuse of follow-up procedures for something that usually resolves on its own," said Alan Waxman, who led the ACOG team that drew up the recommendations.

The new guidelines also recommend that most women under 30 be screened every two years instead of annually, and that women older than 30 who have had three consecutive negative cervical cytology test results be screened once every three years instead of yearly.

Certain women, including those carrying the HIV virus, with suppressed immune systems or who have been treated for cervical cancer, may need to be screened more often, the guidelines said.

ACOG made its revisions after a data review showed that "screening at less frequent intervals prevents cervical cancer just as well, has decreased costs and avoids unnecessary interventions that could be harmful," Waxman said.

Cervical cancer rates have fallen by more than half in the past 30 years in the United States , thanks to the widespread use of the Pap smear test, ACOG said.

In 1975, nearly 15 women per 100,000 in the United States had the slow-growing cancer, which is caused by certain strains of the human papillomavirus (HPV).

Thirty-one years later, in 2006, the rate was 6.5 women per 100,000.

The new recommendations are to be published in the December issue of Obstetrics and Gynecology.

 

OraSure settles HIV test patent lawsuit

(AP) – 20 November, 2009

BETHLEHEM , Pa. — OraSure Technologies Inc., which makes diagnostic kits to detect HIV and drug use, said Thursday it will pay Inverness Medical $3 million to settle a patent dispute over HIV tests.

Under the deal, OraSure settles the lawsuit filed against the company by Inverness and Church & Dwight Co., with Inverness receiving $3 million in cash.

The companies are also granting each other distribution rights to certain products, including HIV hepatitis C tests, and flu tests.

OraSure now expects a fourth-quarter loss of 10 cents to 11 cents per share because of the legal charge.

On average, analysts surveyed by Thomson Reuters forecast a quarterly loss of 8 cents per share. The estimates typically exclude one-time charges.

Shares of OraSure fell 15 cents, or 3.5 percent, to $4.19 in midday trading. The stock has traded between $2.16 and $4.55 over the last 52 weeks.


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