nov07-1-1

Tue Nov 13, 2007 5:44 PM ET

WASHINGTON (Reuters) - Thousands of people who volunteered to test an experimental AIDS vaccine that may have actually raised the risk of infection will be told if they got the actual shot, researchers said on Tuesday.

Merck & Co. Inc. and academic researchers said they would "unblind" the study, meaning everyone would find out who got the active shot and who got a dummy injection.

Two international trials of the experimental vaccine were stopped in September after it became clear the vaccine did not prevent infection with the AIDS virus.

The trials were conducted in the United States, Peru, Brazil, Dominican Republic, Haiti, Jamaica, Australia and South Africa.

Earlier this month, researchers said they saw some worrying indications that the vaccine somehow raised the risk of infection, although they stressed the vaccine could not itself cause HIV infection.

They had already begun counseling volunteers that they could be at higher risk of HIV, a fatal and incurable virus that causes AIDS.

"All study volunteers will be encouraged to continue to return to their study sites on a regular basis for ongoing risk reduction counseling and study-related tests," the researchers said in a statement.

"Study investigators are being advised this week to provide this information to the volunteers; volunteers will receive additional information about the unblinding process directly from study sites."

To test vaccines and new drugs, researchers always aim for what are called placebo-controlled, double-blinded trials. These mean that neither the researchers nor the volunteers know who gets a placebo and who gets an active ingredient, so that there is no bias in determining how well the treatment works.

Study shows how some AIDS vaccines may harm

WASHINGTON (Reuters) - Some viruses being used in experimental AIDS vaccines may damage the immune system by exhausting key cells, researchers reported on Thursday in a finding that may further cloud the field of HIV vaccines.

They said vaccines using the viruses should not be tested on people until more studies are done. But other vaccine experts said the findings, while scientifically interesting, were not a cause for immediate alarm.

The usually harmless viruses are used as so-called vectors to carry genetic material from the AIDS virus into the body so that the immune system can recognize and rally against it.

But the viruses, called adeno-associated viruses, may themselves be doing harm, said Dr. Hildegund Ertl, director of the Wistar Institute Vaccine Center in Philadelphia.

In mice, the adeno-associated virus, or AAV vaccines, directly interfered with immune cells called CD8 T-cells, Ertl's team reported in the Journal of Clinical Investigation. These are the "killer" T-cells that a vaccine is supposed to muster to fight HIV.

"It is simply a defense mechanism of T-cells -- if there is too much antigen for too long a time they simply turn themselves off."

Antigens are the proteins the immune system uses to recognize enemies such as bacteria and viruses. In the case of HIV, turned-off T-cells could leave a person more vulnerable than usual to infection.

"AAVs do not cause disease," Ertl's team wrote. They cannot even replicate on their own, instead piggybacking onto adenoviruses, which cause colds, or herpes viruses.

Ertl said it was unclear whether her findings might cast light on the troubling developments in a trial of an AIDS vaccine that used another virus, an adenovirus.

Vaccine maker Merck & Co stopped that trial in September and said last week it appeared that the adenovirus used in the vaccine may have somehow made patients more vulnerable to HIV infections.

The International AIDS Vaccine Initiative or IAVI used an adeno-associated virus in a trial of an AIDS vaccine that wrapped up in January in Belgium, Germany and India, and another in South Africa, Uganda and Zambia.

"While we find the AAV study by Dr. Ertl and her group ... very interesting and we'll consider whether it can inform our future studies, their study was conducted in mice and there are fundamental differences between mice and humans in their respective immune responses, particularly with regard to the immune response against HIV," Fast said in a statement.

"The dose given to these mice was equivalent, on the basis of body weight, to 3,000 to 4,000 times the highest dose given to humans in the ... study in India."

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the study should be taken "with a very heavy dose of caution".

He noted that adenoviruses and adeno-associated viruses are very different microbes, despite the similarity of their names.

"We may be dealing with apples and oranges," Fauci said in a telephone interview.

First sex report on Chinese farmer workers published

The eighth issue of The Chinese Journal of Human Sexuality in 2007 published a report on the sex lives of farmer workers in southeast China's Zhejiang Province, the first of its kind in China.

Zhang Wenwei, Vice Director of the Shaoxing Health Bureau in Zhejiang and also an expert on reproductive medicine, designed the questionnaire.

The survey interviewed 776 farmer workers in Zhejiang, with 481 of them married -- 307 males and 174 females.

According to the survey, 83.93 percent of the farmer workers meet their spouses yearly, while 16.07 percent haven't met for over a year. Some workers haven't gone home for more than two years. The farmer workers say that they miss their spouses the most, then their children and finally their parents. Additionally, 5.59 percent stated that they don't miss anyone.

Of the 533 migrant workers from other provinces and regions, 41.84 percent of them want a sexual life outside of marriage. Of this category 12.01 percent have that thought often, among which 24.50 percent not only have the intention, but also carry through. These men have relations with mistresses, colleagues and prostitutes. Mistresses are the most common among migrant men, accounting for 67.05 percent.

Of all the 776 farmer workers, 139 claimed that they had encountered sexual harassment -- 20 from superiors, 25 from companions, the remainder from other sources. How do they react to sexual harassment? They answered as follows: 22 accepted it; 27 tolerated it; 90 refused it.

Moreover, 54 claimed that they had committed sexual harassment and 23.9 percent of the migrant workers claim to suffer from sexual depression. In that population 26.18 of them do other things to distract themselves, while 16.18 percent masturbate, and 11.62 percent live on sexual fantasies. Additionally, some feel very bad tempered and/or use masturbation tools, while others seek a sexual life beyond marriage and/or go whoring.

Of the 500 migrant workers who answered questions about prostitutes, 51.2 percent said that they had encountered temptation from prostitutes, 22.95 percent wanted to find a prostitute and 15.82 percent had received sexual services from the prostitutes.

"The migrant workers suffer from sexual dysfunctions and diseases, but they seldom go to hospitals for treatment. The majority of them just tolerate their malady by consuming tonics or buying medicines on their own. In this way, we can see how these people view sex in general," Zhang Wenwei said in conclusion after reviewing the survey.

According to the Zhejiang provincial statistics bureau, in 2006, there were 17.83 million farmer workers in Zhejiang, with 12.60 million local farmer workers and 5.23 million non-local migrant workers. These people play an important role in enhancing the development of Zhejiang's economy.

"This survey is unique in China; it has greatly assisted the public in learning about real life situation of our farmer workers," Zhang said.

"We didn't conduct this survey just out of prurient curiosity. Actually, we want to provide humanistic care," Zhang explained.

Some OBs unclear on HIV testing requirements

Fri Nov 16, 2007 2:40 PM ET

NEW YORK (Reuters Health) - Although virtually all obstetrician-gynecologists recommend HIV testing to all their pregnant patients, some are unaware of their state requirements for recommending such testing, according to a report in the Obstetrics & Gynecology.

Several organizations, including the Centers for Disease Control and Prevention, have recommended that all pregnant women be screened for HIV, using an opt-out approach, as part of routine prenatal care, the authors explain.

With the opt-out testing strategy, the woman tested unless she explicitly refuses. She is provided information on HIV and told that a test will be performed as part of a battery of standard tests. She is also informed that she has the right to decline testing.

The opt-in testing approach requires an explicit request for an HIV test. After a woman has received HIV information, she is asked if she wants an HIV test. She is tested only if she specifically agrees and, in most cases, signs and an informed consent form.

Dr. Jay Schulkin and colleagues from the American College of Obstetricians and Gynecologists, Washington, DC surveyed obstetrician-gynecologists regarding HIV knowledge. A total of 1,032 questionnaires were sent out and 582 were returned.

All but 3 percent of obstetrician-gynecologists reported that they recommend HIV testing to all of their pregnant patients, the authors report, though nearly three quarters of obstetrician-gynecologists considered 5 percent or fewer of their pregnant patients to be at high risk for HIV infection.

Obstetrician-gynecologists were fairly evenly divided as to whether they tested their pregnant patients for HIV using the opt-in approach (52 percent) or the opt-out approach (48 percent).

Just over half the obstetrician-gynecologists (57 percent) reported using the HIV testing approach required in their states, the researchers note, while 43 percent reported using an approach not consistent with their state's regulation.

Nearly one third of obstetrician-gynecologists said they did not know if their state required HIV testing during pregnancy.

Most obstetrician-gynecologists responding to the survey reported that they provide pretest counseling before HIV testing (73.7 percent) and post-test counseling (84.6 percent).

"The results of this study suggest that obstetrician-gynecologists may benefit from additional information that could improve their knowledge and practice regarding HIV screening," the investigators write.

"Although most respondents report being at least moderately knowledgeable about HIV during pregnancy and report recommending HIV testing to all pregnant patients, they may need to be more aggressive in following up with patients who decline HIV testing."

Adherence to HIV therapy linked to health literacy

NEW YORK (Reuters Health) - HIV infected patients with low literacy levels often don't understand the medication instructions offered by healthcare providers and are therefore much less likely to be compliant with treatment, study findings suggest.

The findings also indicate that African Americans with HIV infection are more than twice as likely to be nonadherent compared with their white counterparts. However, when the data were analyzed, lead investigator Dr. Chandra Y. Osborn, at Northwestern University, Chicago, and colleagues found that health literacy mediated the racial disparities.

The level of health literacy was determined by the subjects' overall literacy skills, the researchers explain. Past studies have shown that low health literacy is associated with poor health outcomes and is more common among African Americans than whites.

Osborn's group investigated the association between health literacy and racial differences in medication adherence over time among 204 HIV-infected patients attending outpatient clinics in Chicago and Shreveport, Louisiana. The patients, 80 percent male and 45 percent African American, were 40 years of age, on average.

Overall, more than 70 percent of the study participants were taking three or more HIV medications and more than half were being treated for other chronic illnesses, the investigators report in the American Journal of Preventive Medicine.

A health-related word recognition test identified 68.6 percent of the patients with adequate health literacy (reading at a ninth grade or higher level). Slightly more than 20 percent of the participants had marginal health literacy (7th to 8th grade reading level) and about 11 percent had low health literacy.

The researchers found that the African Americans were 2.4 times more likely to be non-adherent to their medication regimens compared with non-African Americans when the analysis factored in the effects of age, gender, income, number of medications, and non-HIV comorbidities, Osborn said.

Osborn told Reuters Health that when the effects of literacy were considered, "literacy was a significant predictor of non-adherence, such that patients with low literacy were 2.1 times more likely to be non-adherent to their medication regimen than patients with adequate literacy."

Limited health literacy is a potentially modifiable barrier to medication adherence, the investigators note. Those at risk for medication non-adherence may benefit from culturally relevant health education materials and medication labeling written for all literacy levels.

They looked at the rates of both disease and deaths for 13 illnesses prevented by vaccines, most given in infancy and childhood, and found they have worked as intended.

"The number of cases of most vaccine-preventable diseases is at an all-time low; hospitalizations and deaths from vaccine-preventable diseases have also shown striking decreases," the researchers wrote in their report, published in the Journal of the American Medical Association.

"These achievements are largely due to reaching and maintaining high vaccine coverage levels from infancy throughout childhood by successful implementation of the infant and childhood immunization program."

Sandra Roush of the Centers for Disease Control and Prevention and colleagues examined the illness and death rates for 13 vaccine-preventable diseases -- diphtheria, pertussis (whooping cough), tetanus, polio, measles, mumps, rubella, invasive Haemophilus influenzae type b (Hib), acute hepatitis B, hepatitis A, varicella (chickenpox), Streptococcus pneumoniae and smallpox.

Smallpox was eradicated globally in 1979 thanks to vaccination and now the immunization is not routinely given to the general public.

"Vaccines are one of the greatest achievements of biomedical science and public health," Roush and her team wrote.

The U.S. statistics showed striking reductions in both disease and death. For example, between 1936 and 1945, more than 21,000 people on average became infected with diphtheria and 1,800 died on average every year. There were no cases or deaths in 2006.

Between 1953 and 1962, more than 500,000 people caught measles every year and 440 died of it. There were 55 cases in 2006.

The decline in cases of mumps was 95.9 percent after mandatory vaccination. Tetanus cases fell by 92.9 percent, and whooping cough cases declined by 92.2 percent. Deaths from tetanus and whooping cough fell by 99 percent.

U.S. children must show they have current vaccinations to attend most schools, or parents must declare they have a recognized philosophical or religious objection to vaccination.

Some parents have expressed fears about the safety of vaccines and in some communities groups have refused vaccination. The researchers said this has been shown to endanger both those who do not get vaccinated, and people they come into contact with.

The study did not include influenza because the vaccine must be reformulated and administered every year. (Reporting by Maggie Fox, editing by Julie Steenhuysen and David Storey)

U.S. chlamydia, gonorrhea, syphilis rates rise

By Will DunhamTue Nov 13, 3:07 PM ET

The rates of three leading sexually transmitted diseases -- chlamydia, gonorrhea and syphilis -- rose again in the United States last year, worried public health officials said on Tuesday.

It was the second year in a row of increases for all three of these sexually transmitted bacterial infections, the Centers for Disease Control and Prevention said.

The rate of chlamydia, the most common infectious disease reported to the CDC, increased 5.6 percent in 2006 from 2005.

More than 1.03 million chlamydia cases were reported in 2006 -- the highest number since the CDC began tracking it in 1984 and the highest number of annual U.S. cases ever for any sexually transmitted disease.

The CDC said the national rate of reported chlamydia cases in 2006 was 347.8 cases per 100,000 Americans. The rate has been rising since the 1980s but likely reflects less than half the actual occurrence, the CDC said.

The rate of gonorrhea rose 5.5 percent in 2006 -- its second straight yearly gain -- with 358,366 cases reported. In 2006, the gonorrhea rate was 120.9 cases per 100,000 people.

Rates for blacks were eight times higher than for whites for chlamydia and 18 times higher for gonorrhea.

The rate of syphilis, with gay and bisexual men accounting for 64 percent of cases, rose 13.8 percent in 2006 over 2005, with 9,756 cases. Syphilis rates have been rising over the past six years, gaining 57 percent since 2001, the CDC said.

The 2006 syphilis rate was 3.3 cases per 100,000 people.

Sexually transmitted diseases, or STDs, represent a significant public health threat, the CDC said, with about 19 million new infections occurring each year in a country of 300 million people -- almost half among people ages 15 to 24.

"This is a hidden epidemic," said Dr. Stuart Berman, who helps tracks STDs for the CDC.

"Most people are not aware of how many STDs are out there, the risks that they run and the need for getting regular testing for some of these and treatment -- and having their partners treated. We'd like to see these rates going down."

UNREPORTED DISEASES

The CDC said many STD cases go undiagnosed, and some common viral infections such as human papillomavirus -- which causes cervical cancer -- and genital herpes are not reported to the agency at all.

Dr. John Douglas, who heads CDC STD prevention efforts, said more risky sexual behavior by gay and bisexual men is helping fuel syphilis rates. He said expanded screening efforts may help explain the rise in chlamydia reports.

Having multiple sex partners and not using condoms can increase the risk of spreading sexually transmitted diseases, including syphilis and AIDS.

Douglas said STD prevention programs in local and state health departments have been stretched thin financially. And he said the lack of health insurance among many Americans might be contributing as well.

Chlamydia is easily cured with antibiotics, but often goes undiagnosed. When untreated, it can cause severe health consequences particularly for women such as pelvic inflammatory disease, ectopic pregnancy and infertility.

The CDC estimated there are about 2.8 million new cases of chlamydia among Americans each year, far higher than the reported number of cases. The rate for women is three times higher than for men.

STDs raise one's vulnerability to the AIDS virus and makes HIV-infected people more infectious. Left untreated, gonorrhea can cause a variety of health problems including infertility.

Syphilis, easily curable in its early stages, can cause serious complications if untreated, including brain, cardiovascular and organ damage, and even death.

(Editing by Maggie Fox and Cynthia Osterman)

Deadly Ebola virus can mutate, French scientists warn

PARIS (AFP) - French scientists said Monday the Ebola virus can swap genetic material to create new strains, a finding with wide ramifications for attempts to curb this vicious pathogen.

Until now, there was only one known strain of the so-called Zaire species of Ebola, the most brutal member of the Ebola viral family. It goes by the acronym of ZEBOV.

ZEBOV accounts for nearly nine-tenths of all deaths from haemorrhagic fever since Ebola was discovered in 1976 and was notably to blame for a six-week outbreak last September and October in the Democratic Republic of Congo (DRC).

Investigators at France's Institute for Development Research (IRD) said that a probe into an outbreak of Ebola in Gabon and the Republic of Congo had thrown up a new variation of ZEBOV.

Its genome differs from the known lineage of ZEBOV by between two and three percent, and the change can only be explained by recombination, a process in which two viruses exchange genetic material.

Mutation of this kind is well known in the human immunodeficiency virus (HIV) which causes AIDS.

But, the researchers said, it is "much more rare" for recombination to occur among Filoviridiae viruses, the clan to which the four categories of haemorrhagic viruses belong.

It causes the feverish patient to bleed under the skin and in severe cases, from the mouth, ears and eyes. Blood loss, shock and organ failure lead to coma and delirium and, in many cases, to death.

The IRD study is based on a mutation of a key protein gene taken from samples from six gorillas and a chimpanzee which died from Ebola in Gabon and the Republic of Congo between 2001 and 2006.

The new variation has been called ZEBOV B to distinguish it from the original strain, which henceforth will be known as ZEBOV A.

A "family tree" of the virus's evolution and a closer look at samples taken from human cases of Ebola suggest that ZEBOV B emerged from a recombination event that took place some time between 1996 and 2001, and was probably to blame for epidemics that struck Gabon and the Republic of Congo between 2001 and 2003.

The IRD team, led by Gabon-based Eric Leroy, said the discovery would shed important light on the dynamics of Ebola epidemics and implied that "some still unknown, much less pathogenic, strains circulate in the wild."

A typical approach in vaccine research is to use a so-called live attenuated virus -- a virus whose pathogenicity has been dampened -- to induce immune responses against a pathogen.

But this approach would be dangerous in Ebola as the attenuated virus could possibly recombine with a wild virus, creating a new, hybrid virus, the IRD said in a press release.

"The next step is to identify the exact genome location where this genetic material exchange between viral lineages takes place," the IRD said. "In order to do that, the complete genetic mapping of the different viral strains remains to be accomplished."

The IRD study was published online on October 17 by the Proceedings of the National Academy of Sciences (PNAS) in the United States.

An outbreak of Ebola virus in northwestern Republic of Congo killed 5,000 Western gorillas in Congo's Lossi Sanctuary park from 2002 to 2004, a study published last December in the US journal Science said.

The death toll was probably only a "small fraction" of gorillas likely to have been killed by Ebola in the past decade, it said.

Merck tells AIDS vaccine volunteers who got jab

Study shows how some AIDS vaccines may harm

First sex report on Chinese farmer workers published

Some OBs unclear on HIV testing requirements

Adherence to HIV therapy linked to health literacy

Vaccines cut disease deaths by 99 percent-US study

U.S. chlamydia, gonorrhea, syphilis rates rise

Deadly Ebola virus can mutate, French scientists warn

FDA Approves Abbott's Pediatric HIV Drug

ViroPharma's Camvia Gets Orphan Status

Merck HIV Drug Gets Positive Nod From EU