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In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

“These new findings represent an important step forward in HIV vaccine research,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study. “For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.”

“We thank the trial staff in Thailand and the United States for their years of effort in successfully conducting this study and the study participants and the people of Thailand for their long-standing support of HIV vaccine research,” Dr. Fauci adds.

The Thai Phase III HIV vaccine study, also known as RV144, opened in October 2003. The placebo-controlled trial tested the safety and effectiveness of a prime-boost regimen of two vaccines: ALVAC-HIV vaccine (the primer dose), a modified canarypox vaccine developed by Sanofi Pasteur, based in Lyon, France, and AIDSVAX B/E vaccine (the booster dose), a glycoprotein 120 vaccine developed by Vaxgen Inc., and now licensed to Global Solutions for Infectious Diseases (GSID), based in South San Francisco, Calif. The vaccines are based on the subtype B and E HIV strains that commonly circulate in Thailand. The subtype B HIV strain is the one most commonly found in the United States.

Led by principal investigator Supachai Rerks-Ngarm, M.D., of the Thai Ministry of Public Health’s Department of Disease Control, the study was sponsored by the U.S. Army in collaboration with NIAID, Sanofi Pasteur and GSID. The trial, conducted in the Rayong and Chon Buri provinces of Thailand, enrolled 16,402 men and women ages 18 to 30 years old at various levels of risk for HIV infection. Study participants received the ALVAC HIV vaccine or placebo at enrollment and again after 1 month, 3 months, and 6 months. The AIDSVAX B/E vaccine or placebo was given to participants at 3 and 6 months. Participants were tested for HIV infection every 6 months for 3 years. During each clinic visit, they were counseled on how to avoid becoming infected with HIV.

In the final analysis, 74 of 8,198 placebo recipients became infected with HIV compared with 51 of 8,197 participants who received the vaccine regimen. This level of effectiveness in preventing HIV infection was found to be statistically significant. The vaccine regimen had no effect, however, on the amount of virus in the blood of volunteers who acquired HIV infection during the study.

“The Thai study demonstrates why the HIV vaccine field must take a balanced approach to conducting both the basic research needed to discover and design new HIV vaccines and, when appropriate, testing candidate vaccines in people,” says Margaret I. Johnston, Ph.D., director of NIAID’s Vaccine Research Program within the Division of AIDS. “Both avenues provide critical information that will continue to help us better understand what is needed to develop a fully protective HIV vaccine.”

NIAID and the collaborating partners are working with other scientific experts to determine next steps, including additional research of the RV144 vaccine regimen and the need to consider the impact of these new findings on other HIV vaccine candidates.

Individuals who acquired HIV infection while participating in the Thai trial have been provided access to HIV care and treatment, including highly active antiretroviral therapy based on the guidelines of the Thai Ministry of Public Health.

For more information about the Thai Phase III HIV vaccine trial, please see: www.hivresearch.org.

Infants with severely flat heads caused by their sleep position have a higher-than-normal rate of ear infections, a new study has found.

The recommendation to place babies on their backs to sleep has reduced cases of sudden infant death syndrome but has increased the number of infants with flattening of the back of the head, according to researchers at Wake Forest University Medical Center in North Carolina.

They asked the parents of 1,259 children with what is called positional plagiocephaly about their child’s history of ear infections and found that half of the children had at least one ear infection before they were 1 year old. That’s similar to the rate in the overall population, they noted.

However, the rate was 54 percent for children with severe flattening, the study found.

In 124 children, the researchers performed a test called a tympanogram to measure pressures within the middle ear. They found a “marked trend” toward an association between ear-infection-related abnormalities and the severity of plagiocephaly.

“The significantly high percentage of tympanogram readings that pointed to otitis media [ear infection] … suggests an overall malfunction of the middle ear drainage function of the eustachian tube in these children,” the researchers wrote.

The study is in the September issue of the Journal of Craniofacial Surgery.

Because ear infections can have a major impact on hearing and other aspects of child development, the researchers noted, further study is needed to learn more about ear infection risk in children with positional plagiocephaly.

Johnson & Johnson said on Thursday it is recalling some lots of infants’ and children’s Tylenol because of a possible bacterial contamination of the popular pain and fever treatment.

Tylenol products being recalled were manufactured between April and June 2008, the diversified healthcare giant said.

The company identified 21 varieties of the products, which come in various flavors and forms, and 57 different lot numbers, affected by the recall..

The company said it has contacted wholesalers and retailers about the recall, which affects only the United States. It was not immediately clear how widely distributed the 57 affected lots were within the United States.

In a letter dated September 18, J&J unit McNeil Consumer Healthcare said that after consulting with the U.S. Food and Drug Administration, it initiated the voluntary recall as a precaution.

The company said that one of the inactive ingredients did not meet internal testing requirements and Burkholderia cepacia, or B. cepacia, bacteria were detected in a portion of raw material that was not used in the finished product.

“However, it was decided, as a precaution, to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria,” the letter said, emphasizing that no bacteria were found in the finished product, which met all specifications.

J&J said the likelihood of a serious medical problem arising from the recalled product was remote.

“The FDA is working closely with the company to monitor this recall,” agency spokeswoman Sandy Walsh said.

“There are no adverse events reported by patients using this product,” she added.

Health consequences of B. cepacia infections could be severe in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems.

Johnson & Johnson shares closed down 5 cents at $60.72 on the New York Stock Exchange.

Medications, personal hygiene, mask-wearing and quarantines all help prevent the spread of viral infections such as the flu, and researchers now suggest that the latter three strategies should be given more attention in plans to deal with pandemics.

In an update of a 2007 study, Dr. Tom Jefferson of the Cochrane Acute Respiratory Infections Group in Rome, Italy, and colleagues reviewed the results of 59 studies that looked at the effectiveness of strategies to reduce the spread of viral germs that cause respiratory diseases such as the flu and SARS. The new review appears online Sept. 22 in BMJ.

The researchers looked at studies that compared a number of strategies (quarantine/isolation, distancing sick people from healthy people through other methods, better hygiene) with other interventions, or doing nothing.

The review found that wearing gloves, gowns and masks is effective, and so is hand washing more than 10 times a day. The strategies are even more effective when people use more than one of them.

Jefferson’s team also found that the highest quality studies reported that the spread of diseases can be lowered through hygiene in households and among young children.

The researchers found only limited evidence that so-called N95 facial masks, which are uncomfortable and expensive, are better than simple surgical masks.

Also, they noted that it is unclear whether people need to add antiseptics to normal soap and water.

The researchers called for national school programs to encourage hand washing and stressed that gloves, gowns, masks and isolation of certain patients are all appropriate when there’s high risk that the respiratory diseases will spread.

“More resources should be invested into studying which physical interventions are the most effective, flexible and cost-effective means of minimizing the impact of acute respiratory tract infections,” the study authors concluded.