Wall Street Journal/Associated Press reports: "For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible."
"The vaccine cut the risk of becoming infected with HIV by more than 31% in the world's largest AIDS vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok. Even a marginally helpful vaccine could have a big impact. Every day, 7,500 people world-wide are newly infected with HIV and two million died of AIDS in 2007, the U.N. agency UNAIDS estimates. The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Whether such a vaccine would work against other strains in the U.S., Africa or elsewhere in the world is unknown, scientists stressed. The study actually tested a two-vaccine combo in a "prime-boost" approach, where the first one primes the immune system to attack HIV and the second one strengthens the response" (9/24).
CNN reports that Col. Jerome Kim, who is the HIV vaccines product manager for the U.S. Army, "emphasized that the level of efficacy was modest, but given the failures of previous HIV vaccine trials, 'yesterday we would have thought an HIV vaccine wasn't possible.' He called the results from the trial an important first step that will help researchers work toward a more effective vaccine. Researchers have tried to prevent the spread of HIV since they discovered its cause in 1986. Previous vaccine trials failed to prevent infection. And during one trial, the vaccine seemed to boost the chance of being infected, which ended testing early.
"The new study was conducted in Thailand, with more than 16,000 people between ages 18 and 30 participating. They were all HIV negative at the beginning of the trial. Nearly 8,200 received a placebo and a similar number received a combination of six vaccines over six months. All were followed for three years. The study was funded by the National Institutes of Allergy and Infectious Diseases and the U.S. Army Medical Research and Materiel Command. According to Kim, the U.S. military was involved in the study because U.S. service members are at risk and 'there's a national security threat from HIV'" (Falco, 9/24).
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FDA Panel Votes to Approve Second HPV Vaccine
By Michael J. Him puty Managing Editor; Emily P. Walker, Washington Correspondent at medpagetoday.com
WASHINGTON -- An FDA advisory panel today voted to recommend approval of GlaxoSmithKline's Cervarix vaccine for use against the two strains of human papillomavirus (HPV) that cause 70% of cervical cancers.
In a separate action, the Vaccines and Related Biologics Committee recommended that the agency okay Merck's application to extend the use of its HPV vaccine, Gardasil, against genital warts in males ages 9 through 26.
In considering Merck's request to extend Gardasil's approval to males, the committee voted 7-0 that data support the vaccine's effectiveness in preventing genital warts caused by HPV types 6 and 11. The vote was 7-1 on the safety of the vaccine. FDA staff papers likewise favored the endorsement.
HPV in males can produce skin warts, genital warts, penile intraepithelial neoplasia, penile cancer, anal intraepithelial neoplasia, anal cancer, oropharyngeal cancer, and recurrent respiratory papillomatosis, but Merck's current application is just for the prevention of genital warts.
Genital warts are the most common presenting complaint in both males and females with HPV. About 1% of the entire U.S. sexually active population is estimated to have genital warts. About 200 per 100,000 males are newly diagnosed with genital warts each year, according to the FDA.
Most genital warts are caused by genital infection with HPV, particularly types 6 and 11 which are found in 70% to 100% of lesions.
The sponsor is seeking approval based on a phase III study of 4,065 boys and men who were randomized to receive the three-dose Gardasil vaccine or placebo.
