AIDS Vaccine Success Is ‘Modest’

“Modest” success in an HIV vaccine trial shows for the first time that vaccination can protect people against infection with the AIDS virus.

It’s a small but significant step forward. Few, if any, think this vaccine is effective enough to deploy in the worldwide fight against AIDS. But many experts say it offers badly needed hope to an effort marked by many expensive failures.

“While these results are encouraging, we recognize that further study is required to build upon these findings,” Col. Nelson Michael, director of the U.S. Military HIV Research Program, says in a news release.

The trial was a collaboration between the U.S. Army, Thailand, the U.S. National Institute of Allergy and Infectious Diseases, Sanofi Pasteur, and Global Solutions for Infectious Diseases. It tested Sanofi’s ALVAC vaccine boosted with a dose of GSID’s AIDSVAX.

Conducted in Thailand, it began in 2003 and enrolled 16,402 adult, HIV-negative men and women. Half got the two-part vaccine, and half got inactive placebo shots.

Over the course of the study, 74 placebo recipients and 51 vaccine recipients became infected with HIV. The difference isn’t large, but it translates into 31% vaccine effectiveness. That is, it lowered the risk of getting HIV by 31%.

That’s “an important step forward in HIV vaccine research,” NIAID director and long-time AIDS researcher Anthony Fauci, MD, says in a news release. “Certainly this is an encouraging advance.”

Even so, the study results are puzzling. It was expected that vaccine recipients who became infected would at least have some protection against the virus. But the study found no evidence of such protection. HIV levels were just as high in vaccine recipients who became infected as in placebo recipients who contracted the virus.

Perhaps more importantly, the study fell far short of its goal of reducing the risk of HIV infection by 50%.

The study was controversial from the outset. It’s the largest HIV vaccine trial yet conducted, and some AIDS activists called the study a waste of precious resources.

AIDSVAX, the first HIV vaccine ever to be tested, had already failed to prevent HIV in a number of trials. ALVAC, a live canarypox virus carrying HIV genes, did not appear to stimulate strong immune responses in healthy people. And similar combination vaccine strategies showed little evidence of eliciting strong immune responses.

Moreover, a similar study of the ALVAC and AIDSVAX vaccines had been canceled in the U.S. And critics said the study design would make it hard to tell which part of the vaccine regimen was or was not effective.

Now that the study is completed, researchers will go over the data with a fine-tooth comb. They’ll try to figure out what worked and build on that success.

“Knowledge gained through this study will be used to accelerate future study design and testing as researchers continue the search for a safe, globally effective HIV vaccine,” Col. Jerome Kim, HIV vaccines product manager for the U.S. Army, says in a news release.

SOURCES: News release, National Institute of Allergy and Infectious Diseases. News release, U.S. Military HIV Research Program. News release, AIDS Vaccine Advocacy Coalition. News release, World Health Organization. News release, Fred Hutchinson Cancer Research Center. News release, International AIDS Vaccine Coalition. News release, Treatment Action Group. News release, National Institute of Allergy and Infectious Disease.

Does Helicobacter pylori eradication therapy prevent gastric cancer?

Although it has been demonstrated that Helicobacter pylori causes gastric cancer, it is still controversial that whether H. pylori eradication therapy is effective in primary prevention of gastric cancer. This is especially important for Yamagata Prefecture, a region of Japan with the second highest incidence of gastric cancer in the world.

A research article to be published on September 14, 2009 in the World Journal of Gastroenterology addresses this question. A research team led by Dr. Katsuhiro Mabe from Division of Gastroenterology of KKR Sapporo Medical Center did a multicenter, prospective cohort study in residents of Yamagata Prefecture between 2000 and 2007. They compared the incidence of gastric cancer between patients with H. pylori-positive peptic ulcer who underwent H. pylori eradication (eradication group) or conventional antacid therapy (non-eradication group) at the patients’ discretion. A total of 4133 patients with a mean age of 52.9 years were registered, and 56 cases of gastric cancer were found over a mean follow-up period of 5.6 years. The sex- and age-adjusted incidence ratio of gastric cancer in the eradication group, as compared with the non-eradication group, was 0.58 (95% CI: 0.28–1.19). The ratios by follow-up period of < 1 year, 1–3 years, and > 3 years were 1.16 (0.27–5.00), 0.50 (0. 17–1.49), and 0.34 (0.09–1.28), respectively, which indicated that longer follow-up tended to be associated with better prevention of gastric cancer. There was no significant difference in incidence of gastric cancer between patients with and without successful eradication therapy. However, among patients with duodenal ulcer, which is more common in younger individuals, the incidence of cancer was significantly less in those with successful eradication.

The results of the study, which revealed no overall prevention of gastric cancer by eradication therapy for peptic ulcer during observation highlight the importance of longer and careful follow-up after eradication therapy. Furthermore, the significant efficacy of treatment observed in younger patients suggests the need to eradicate H. pylori as early as possible.

Young Adults Visit Doctors Least at an Age When Risky Behavior Peaks

When adolescents graduate to young adulthood, their preventive care tends to fall by the wayside. A recent study has found that young adults are much less likely to use ambulatory or preventive care, even though their mortality rate is more than twice that of adolescents.

“Young adults are generally a healthy population, but many risky behaviors peak in young adulthood and few resources are available for this population,” said Robert J.Fortuna, M.D., M.P.H., senior instructor in Pediatrics and Internal Medicine at the University of Rochester Medical Center (URMC). “Despite having the highest rate of many preventable diseases, young adults garner relatively little attention from advocacy groups, researchers or policymakers.”

“Greater awareness is needed among health care providers and policymakers to improve access to care and ensure that young adults receive appropriate preventive services,” said Fortuna. “During a time when many risks peak and unhealthy lifestyle habits form, routine medical care and preventive counseling can improve both immediate and long-term health.”

To characterize ambulatory medical care among young adults age 20 to 29 years, the researchers used data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey between 1996 and 2006.

The authors pointed to the goals of Healthy People 2010, a set of national objectives provided by the U.S. Department of Health and Human Services, as an important reason to evaluate how ambulatory care is used by young adults. The set objectives aim to reduce mortality, motor vehicle crashes, the incidence of STDs and alcohol- and drug-related injuries among young adults. The study concludes that to reach these goals, young adults need to have access to resources that will help them receive appropriate preventive care, especially given the current underuse of ambulatory care services and insufficient amount of counseling available to young adults.

URMC Newsroom

No sex without my statins?!

High cholesterol isn’t just bad for the heart – it could also make it harder for women to become sexually aroused. That might mean that cholesterol-lowering drugs like statins would help to treat so-called female sexual dysfunction (FSD).

Hyperlipidemia, or raised levels of cholesterol and other fats in the blood, is associated with erectile dysfunction in men, because the build-up of fats in blood vessel walls can reduce blood flow to erectile tissue. Since some aspects of female sexual arousal also rely on increased blood flow to the genitals, Katherine Esposito and her colleagues at the Second University of Naples in Italy compared sexual function in premenopausal women with and without hyperlipidemia.

Women with hyperlipidemia reported significantly lower arousal, orgasm, lubrication, and sexual satisfaction scores than women with normal blood lipid profiles. And 32 per cent of the women with abnormal profiles scored low enough on a scale of female sexual function to be diagnosed with FSD, compared with 9 per cent of women without normal levels. Women’s sexual desire was not affected by hyperlipidemia, however.

In a separate paper, Annamaria Veronelli at the University of Milan, Italy, and her colleagues found that female sexual dysfunction was also associated with diabetes, obesity and an underactive thyroid gland.

“These two papers suggest that there are strong connections between women’s sexual arousal and organic diseases in the same way that men’s sexual problems arise,” says Geoffrey Hackett, a urologist at the Holly Cottage Clinic in Fisherwick, UK. “This is currently not even considered in women.”

Hackett therefore suggests that a loss of sexual arousal in women might be an indicator of other underlying conditions, so such problems should be raised with a doctor.

Journal references: Journal of Sexual Medicine, DOI: 10.1111/j.1743-6109.2009.01284.x and DOI: 10.1111/j.1743-6109.2009.01242.x

Latest Guidelines for Kids against H1N1 infection

New guidelines for the H1N1 vaccine may require some children to have two doses, Dr. Jennifer Ashton reports. Harry Smith spoke with Dr. Anthony Fauci about the safety of the vaccine.

Watch it on the following link:

http://www.cbsnews.com/video/watch/?id=5328724n

Swine Flu Vaccine for Kids

Kids under age 10 will need two doses of the H1N1 swine flu vaccine, given three weeks apart.

The finding  early results from clinical trials of the Sanofi Pasteur version of the swine flu vaccine — is no surprise. The CDC bases its swine flu vaccination plan on the need for two shots in younger kids.

In kids over age 10, the H1N1 swine flu vaccine works just as well as it does in adults. These older children will need just one dose of the swine flu vaccine and can expect protection in eight to 10   days.

One shot of the vaccine raised protective antibodies in 76% of older children, a level of protection considered very good for flu vaccines. But a single dose of the vaccine protects only 36% of 3- to   9-year-olds, and only 25% of children age 6 months to 35 months.

“These two younger groups may require two doses of the vaccine,” National Institute of Allergy and Infectious Diseases director Anthony Fauci, MD, said in a news conference held to announce the findings. “This is not an unexpected finding and is quite similar to what we see with seasonal flu vaccine.”

H1N1 swine flu vaccine from other manufacturers — including the inhaled FluMist version — is expected to act in much the same way as the Sanofi product.

More clinical trial data are expected soon. But so far, experts are relieved to see that the H1N1 swine flu vaccines act very much like seasonal flu vaccines. There’s been no sign of unusual side effects in children or adults given the H1N1 swine flu vaccine.

It’s likely that kids will be able to get their seasonal flu shots and their H1N1 swine flu shots on the same day, although clinical trials are still looking at the issue. However, the CDC urges parents to get their kids the seasonal flu vaccine right away and not wait for the swine flu vaccine to become available.

The inhaled FluMist version of the swine flu vaccine cannot be given on the same day a kid gets the FluMist version of the seasonal vaccine. That’s because FluMist contains a live, weakened flu virus and stimulates the immune system in a different way than flu shots, which contain inactivated virus particles.

The first 3.4 million doses of swine flu vaccine to be distributed in the U.S. will be FluMist, although millions more doses of the injectable vaccine will start arriving in mid-October. FluMist is recommended only for kids over age 2 (and adults under age 50) who do not suffer respiratory problems.

Since the H1N1 swine flu first appeared, 47 U.S. children and teens have died of the disease.

Source: WEbMD

Heart Risk Factors Cut Life Span by 10 Years

A 50-year-old smoker who has a history of high blood pressure and high cholesterol can expect to die a decade earlier than someone of the same age with none of these heart disease risk factors.

That is the finding from the widely respected Whitehall study, which followed more than 19,000 middle-aged men in the U.K. for four decades.

The study is one of the largest ever to quantify the benefits of stopping smoking and controlling blood pressure and cholesterol in terms of life expectancy.

“We were able to put a number on what can be achieved by dealing with these three main risk factors for heart disease during middle age,” epidemiologist and study researcher Robert Clarke, FFPH, tells WebMD.

“The presence of all three of these risk factors in a middle-aged person is associated with a 10- to 15-year difference in life expectancy. The good news is these things can be controlled. We can all make changes to help us live a longer, healthier life.”

The death rate from heart disease has dropped steadily since the late 1960s and early 1970s, when recruitment for the study took place.

This decline is largely attributed to a big drop in smoking and the wider availability and use of effective blood pressure and cholesterol-lowering drugs.

When they entered the Whitehall study, 42% of the men who took part were current smokers, 39% had high blood pressure, and half had high cholesterol.

Close to three decades later, when interviewed in 1997, two-thirds of the surviving men had quit smoking, and many also had improved their blood pressure and cholesterol levels.

Middle-aged smokers with elevated blood pressure and cholesterol were three times as likely to die from cardiovascular causes as men with none of these risk factors.

The researchers also concluded that:

• Men with these three risk factors were also twice as likely to die from causes other than heart and vascular disease.
• The life expectancy of a 50-year-old smoker with high blood pressure and high cholesterol was estimated to be 24 years, while a 50-year-old with none of the risk factors could expect to live nine additional years, to age 83.
• When other contributors to heart disease like obesity and diabetes were considered, the life expectancy of men with the fewest risk factors was 15 years longer than men with the most.

There were no women in the study, but Clarke says the impact of smoking, high blood pressure, and high cholesterol on life expectancy in women is probably similar to that reported for men.

“Women do survive longer than men, but that is largely explained by the fact that they have traditionally had fewer of these risk factors,” he says.

Russell V. Luepker, MD, who is a professor of public health at the University of Minnesota, says the study reinforces the message that it is never too late to make meaningful lifestyle changes and add years to your life.

“We all will die eventually, but this study shows that people are likely to die later if they stop smoking and keep their blood pressure and cholesterol at healthy levels,” he says.

H1N1 Vaccine Study Summaries: Single Dose Provides Protection

Preliminary results from two studies published online last week by the New England Journal of Medicine (NEJM) show that a single dose of the H1N1 vaccine will offer protection for most adults within three weeks of vaccination. This is good news in the fight against H1N1, since the vaccine won’t be ready until the start of flu season. Health and Human Services Secretary Kathleen Sebelius said that some vaccine may be available as early as the first full week in October.

Both vaccines were generated from the same vaccine virus (New York Medical College [NYMC] X-179A), and formulated and produced by either CSL CSL “>Biotherapies  or Novartis. The Novartis vaccine is being tested both with and without the company’s proprietary immune-stimulating compound (called an adjuvant), MF59. The CSL vaccine does not contain an adjuvant. Adjuvanted flu vaccines have not been used previously in the U.S. and health officials hope to use a vaccine without an adjuvant because of the regulatory issues involved (more extensive human testing would be required before FDA approval). MF59 has been used extensively in Europe since 1997 with no excess reports of autoimmune conditions.

The CSL Biotherapies H1N1 vaccine

The CSL Biotherapies vaccine was tested in one locality in Australia during winter at two different doses on 240 people (120 for each dose). An equal number of subjects from 18–49 years of age (59% female, 86% white, 43% had previously received seasonal influenza vaccine) and 50–64 years of age (53% female, 98% white, 48% had previously received seasonal influenza vaccine) were evaluated using a 15 microgram dose.

The study also evaluated a double dose (30 micrograms) that many people assumed would be necessary in another group of 120 subjects.

Although a robust immune response to the H1N1 vaccine following a single dose was unanticipated, post vaccination titers of 1:40 or more on hemagglutination-inhibition assay (a quantification of virus by hemagglutination) was observed in 96.7% of the recipients that received the 15 microgram dose and 93.3% of the recipients that received the 30 microgram dose. Titers of 1:40 or greater are considered to be protective. Thus, the low dose actually worked better than the double dose.

Surprisingly, 31.7% of subjects had antibody titers before vaccination of 1:40 or more on hemagglutination-inhibition assay. For subjects who were 50 years of age or older, the researchers suggest that this could be due to the presence of preexisting antibodies from exposure to H1N1 viruses circulating prior to 1957. For younger subjects, there may be a degree of previous 2009 H1N1 infection despite stringent exclusion criteria. Additionally, cross-reactive antibodies may also have played a role.

An increase in detectable specific H1N1 antibodies in blood serum (called seroconversion) occurred in 74.2% of subjects.

No deaths or serious adverse events were reported. The most commonly reported local adverse events within 7 days after receiving one dose of the H1N1 vaccine were injection-site tenderness and pain. Systemic adverse events reported were headache, malaise and muscle pain.

The Novartis H1N1 vaccine  

The Novartis vaccine was tested in one locality in the U.K. during summer on 100 people aged 18–50 (65% female, 82% white, 37% had previously received seasonal influenza vaccine). The vaccine is boosted with the Novartis adjuvant, MF59.

Subjects were randomly assigned in 5 blocks of 20 patients to receive two doses of 7.5 micrograms of MF59-adjuvanted vaccine either concurrently administered on day 0 or administered in two doses, the first at day 0 and the second at day 7, 14 or 21. Data were evaluated at day 21 for four groups of 25 subjects:

• one dose on day 0
• two doses on day 0
• one dose on day 0 and one dose on day 7
• one dose on day 0 and one dose on day 14

Similar to what was observed in the CSL vaccine study, 15% of subjects had detectable prevaccination levels of hemagglutination-inhibition antibody. The researchers suggest that, despite excluding subjects with previous respiratory illness, this may be due to asymptomatic H1N1 infection.

By day 21, post-vaccination titers exceeded 1:32 by hemagglutination-inhibition assay in 88% of subjects who had received one vaccine dose by this time and in 92–100% of subjects who had received both doses.

The development of detectable specific H1N1 antibodies in blood serum occurred in 76% of subjects that received only one dose to date and 88–92% that received both doses.

No deaths or serious adverse events were reported. The most commonly reported local adverse event within 7 days after receiving the first dose of the H1N1 vaccine was injection-site pain. Systemic adverse events reported were headache, muscle pain, malaise and nausea.

More data to come

The discrepancies observed between the two trials may be due to several factors: technical differences in measurement of antigen in the doses used, the limited number of samples evaluated and the early time point following immunization. Additional companies — Sanofi Pasteur, GlaxoSmithKline and AstraZeneca — should be announcing preliminary trial results shortly. H1N1 vaccine studies in children started after the adult studies and aren’t completed yet. Researchers anticipate those results in two weeks.