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2009 H1N1 influenza vaccines well tolerated, induce strong immune response in adults

September 12, 2009 By admin Leave a Comment

Washington, September 12 (ANI): Early results from various clinical trials of 2009 H1N1 influenza vaccines in healthy adults seem to be quite encouraging, say U.S. health experts.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the U.S., has revealed that the early data from these trials suggest that 2009 H1N1 influenza vaccines are well tolerated, and induce a strong immune response in most healthy adults, when administered in a single unadjuvanted 15-microgram dose.

It has even congratulated the companies that have carried out these trials, which it claims are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases is also conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited.

The trials are testing two different dosages-15 micrograms versus 30 micrograms-and evaluating the immune response to one and two doses of these vaccines.

More than 2,800 people are said to be participating in the ongoing NIAID trials of these vaccines.

The institute says that preliminary analyses of early data from its trials align with the recently announced findings, and those to be announced imminently by other companies.

Additional data from the NIAID trials are forthcoming.

“However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines,” the institute said in a press release.

“We note that the slight discrepancies seen in our trials between the Sanofi Pasteur and CSL Limited vaccines may be due to technical differences in the preliminary measurement of the amounts of antigen in the doses used in the clinical trial lots and the relatively limited numbers of samples studied to date, as well as the fact that our data are drawn from a very early time point after immunization,” the institute added. (ANI)

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Male circumcision ‘cuts risk of common STDs, but not syphilis’

March 26, 2009 By admin 1 Comment

London, Mar 26 (ANI): Circumcision not only protects heterosexual men from HIV, but it also helps prevent two other sexually transmitted infections – herpes simplex virus type 2 (HSV-2), the cause of genital herpes, and human papillomavirus (HPV), which can cause cancer and genital warts, says a new study.

However, the New England Journal of Medicine research found that circumcision had no effect on the transmission of syphilis.

“Medically supervised adult male circumcision is a scientifically proven method for reducing a man’s risk of acquiring HIV infection through heterosexual intercourse,” said National Institute of Allergy and Infectious Disease (NIAID) Director Anthony S. Fauci, M.D.

“This new research provides compelling evidence that circumcision can provide some protection against genital herpes and human papillomavirus infections as well,” he added.

Scientists at the Rakai Health Sciences Program in Uganda conducted the study in collaboration with researchers at the Johns Hopkins University Bloomberg School of Public Health in Baltimore, Makerere University in Kampala, Uganda, and NIAID’s Division of Intramural Research.

The team reviewed samples from two parallel clinical trials in Rakai that successfully proved male circumcision as an HIV prevention method and also assessed the surgical procedure’s ability to prevent other sexually transmitted infections, including syphilis and HSV-2.

Scientists also assessed circumcision’s effect on HPV infections, which can cause anal, cervical and penile cancers and genital warts.

The two trials involved enrolled 3,393 uncircumcised men between the ages of 15 and 49 who initially tested negative for both HIV and HSV-2. The men were assigned at random to one of two study groups: 1,684 received immediate circumcision performed by trained medical professionals in an outpatient setting (intervention group); and 1,709 received medical circumcision after a delay of 24 months (control group).

The researchers evaluated the volunteers at six, 12 and 24 months for HSV-2 and syphilis infection. Additionally, a subgroup of 697 volunteers (352 participants in the intervention group; 345 in the control group) was evaluated for HPV infection at enrollment and at 24 months.

In analyzing the effect of circumcision on HSV-2 acquisition across both studies, the researchers found that the cumulative probability of HSV-2 infection was significantly lower among those volunteers who received immediate circumcision (7.8 percent) than among those in the control group who were circumcised at 24 months (10.3 percent). Overall, the researchers found that medically supervised circumcision reduced the men’s risk of HSV-2 infection by 28 percent.

The combined results from both trials also demonstrated a 35 percent reduction in HPV prevalence among men in the intervention group. In evaluating a subgroup of volunteers at 24 months, high-risk HPV strains associated with certain cancers were detected in 42 of 233 men in the intervention group and in 80 of 287 men in the control group.

Circumcision did not, however, affect the incidence of syphilis. At 24 months, syphilis was detected in 50 men in the intervention group and 45 members of the control group. (ANI)

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Vaccine targeting ‘Achilles heel’ in all flu viruses comes closer to reality

February 23, 2009 By admin Leave a Comment

Washington, February 23 (ANI): A potential new flu vaccine to cure almost all kinds of the disease, including bird flue, may be available in just two years because scientists have identified 10 antibodies that target an “Achilles heel” in most forms of influenza.

The researchers have revealed that the antibodies they have discovered target the weak spot in the “neck” of the virus, just below its peanut-shaped “head” which stops it shape-changing and infecting cells.

This finding attains significance because one of the reasons why scientists have failed to find a vaccine to prevent even seasonal flu is that the virus constantly mutates in a bid to fool the immune system.

During a study on mice, the researchers found the antibodies to protect against easily-transmitted H5N1 even when given to the animals three days after they were infected, and to keep them immune for up to three weeks.

That observation, according to them, attained significance because it is feared that millions of lives would be lost from a pandemic before a vaccine is available.

The researchers say that using the antibodies, which can be made quickly and in large numbers into a single dose treatment, in combination with anti-viral drugs may help contain the virus during the four to six months it would take to create enough quantities for a suitable vaccine.

“This is an elegant research finding that holds considerable promise for further development into a medical tool to treat and prevent seasonal as well as pandemic influenza,” Dr. Anthony S. Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, which supported the research project.

“In the event of an influenza pandemic, human monoclonal antibodies could be an important adjunct to antiviral drugs to contain the outbreak until a vaccine becomes available,” he added.

A research article on the breakthrough discovery has been published in the online edition of the journal Nature Structural and Molecular Biology. (ANI)

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Anti-HIV gel shows promise in Aids prevention

February 10, 2009 By admin Leave a Comment

Washington, Feb 10 (ANI): In the first human clinical trial of its kind, a vaginal gel intended to prevent HIV infection in women has shown promise in fighting against the infection.

Called PRO 2000 (Indevus Pharmaceuticals, Inc., Lexington, Mass.), the microbicide gel was found to be safe and approximately 30 percent effective.

A microbicide is a gel, foam or cream intended to prevent the sexual transmission of HIV and other sexually transmitted infections is applied topically inside the vagina or rectum.

The clinical trial, which enrolled more than 3,000 women and conducted in Africa and the United States, suggested that PRO 2000 might prevent male-to-female sexual transmission of HIV infection.

“Although more data are needed to conclusively determine whether PRO 2000 protects women from HIV infection, the results of this study are encouraging,” said NIAID Director Anthony S. Fauci, M.D.

He added: “An effective microbicide would be a valuable tool that women could use to protect themselves against HIV and one that could substantially reduce the number of new HIV infections worldwide.”

“The study, while not conclusive, provides a glimmer of hope to millions of women at risk for HIV, especially young women in Africa. It provides the first signal that a microbicide gel may be able to protect women from HIV infection,” said lead investigator Salim S. Abdool Karim, MBChB, Ph.D., from the Center for the AIDS Program of Research in South Africa.

Mostly, women become infected with HIV through sexual intercourse with an infected male partner. An effective microbicide could provide women with an HIV prevention method they initiate.

This would be particularly helpful in situations where it is difficult or impossible for women to refuse sex or negotiate condom use with their male partners.

The study, known as HPTN 035, began in 2005 and enrolled 3,099 women at six sites in Africa and one in the United States.

The clinical trial tested two candidate microbicide gels for safety and their ability to prevent HIV infection: PRO 2000 (0.5 percent dose), and BufferGel (ReProtect Inc., Baltimore).

PRO 2000 inhibits the entry of HIV into cells; BufferGel boosts the natural acidity of the vagina in the presence of seminal fluid, which can help to inactivate HIV and other pathogens.

In the final analysis, 194 women in the study became infected with HIV. Of these infections, 36 occurred in the PRO 2000 group, 54 in the BufferGel group, 51 in the placebo group and 53 in those who did not use gel.

Based on these data, PRO 2000 was 30 percent effective, while BufferGel had no detectable preventive effect on HIV infection. Both PRO 2000 and BufferGel were found to be safe.

Findings of the study were presented at the Conference on Retroviruses and Opportunistic Infections in Montreal. (ANI)

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2009 H1N1 influenza vaccines well tolerated, induce strong immune response in adults

Vaccine targeting ‘Achilles heel’ in all flu viruses comes closer to reality

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