California, U.S.A. – A new grant from the National Institute of Allergy and Infectious Diseases (NIAID) will support the development of a topical microbicide gel for drug delivery. The innovative gel formulation will be a combination therapy against human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV-2) infections in women.

Every day, more than 3,000 women around the world are newly infected with HIV, and it is the leading cause of death in sub-Saharan Africa. Of the 33.3 million people living with HIV/AIDS across the world, 22.5 million are in Africa. HSV-2 is a global epidemic and affects up to 80 percent of the female population in Africa.

As part of the grant, SRI International researchers will develop and test a prototype bioadhesive formulation for sustained delivery of the antiviral drugs tenofovir and acyclovir to the vaginal surface. Because chronic HSV-2 infections have been shown to speed the progression of immunodeficiency disease, researchers are focused on developing a microbicide that prevents both HIV and HSV-2 infections.

“The inexpensive and easy-to-use combination therapy in development could help contain the spread of HIV and HSV, and possibly other sexually transmitted diseases,” said Gita Shankar, Ph.D., director of Formulations R&D, SRI Biosciences. “One of the strongest benefits of a topical gel formula is that it can offer protection when options such as condoms are unavailable or unacceptable.”

The awarded grant is for two years with a possible extension of three additional years. Development work will focus on creating a combination therapy that will limit the risk of drug resistance, while providing women with safe and sustained drug delivery. The novel product will be based on a patented bioadhesive polymeric platform developed at SRI.

SRI’s Biosciences division carries out basic research, drug discovery, and drug development, and provides contract (CRO) services. SRI has all of the resources necessary to take R&D from “Idea to IND” — from initial discovery to the start of human clinical trials—and specializes in cancer, immunology and inflammation, infectious disease, and neuroscience.

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Ann Arbor, U.S.A. – Most U.S. adults support laws that allow teens to get medical care for sexually transmitted infections without parental consent. But when asked about the vaccine against the human papilloma virus (HPV), most adults want parents to have the final say on whether their teen or pre-teen gets the shots.

The University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health recently asked a national sample of adults about allowing adolescents age 12 to 17 years old to receive the HPV vaccinations without parental consent.

Only 45 percent of those polled would support state laws allowing the HPV vaccination without parental consent.

“But in contrast, 57 percent say they support teens being able to get medical care for prevention of sexually transmitted infections and 55 percent for treatment, all without parental consent,” says Sarah Clark, M.P.H., Associate Director of the Child Health Evaluation and Research (CHEAR) Unit at the University of Michigan and Associate Director of the National Poll on Children’s Health.

In the short term, the HPV vaccine protects against genital warts, one of the most common types of sexually transmitted infection. In the long term, the vaccine prevents development of cervical cancer in females and some head and neck cancers in men.

Routine HPV vaccination is recommended for males and females at 11-12 years of age. The vaccine is most effective if administered before the onset of sexual activity.

“That presents a challenge. Parents aren’t thinking their 11 or 12 year-old child is ready for sexual activity at that age,” Clark says. “Many parents ask to delay the vaccine until their child is a little older. But older teens go to the doctor much less than younger adolescents, and often they go without a parent.”

Public health officials have considered pushing laws that would drop the need for parental consent, in order to boost HPV vaccination rates.

“But in this poll, most agreed they are reluctant to support dropping parental consent, even though 74 percent agreed that getting vaccines is a good way to protect adolescents from disease,” Clark says.

Those who did not support dropping parental consent were asked about their reasons. The most common reason, cited by 86 percent, was that HPV should be a parent’s decision; 43 percent cited the risk of side effects of the vaccine. About 40 percent said they have moral or ethical concerns about the vaccine.

The support for state laws that would allow HPV vaccination without parental consent was not different between parents and non-parents.

“These poll results show the majority of adults view HPV vaccination as distinct from sexually transmitted infection prevention and are reluctant to support taking away parental consent,” Clark says.

“Policymakers and public health officials interested in changing parental consent rules should consider this data and provide education to ensure adults understand the importance of HPV vaccination as a form of prevention against sexually transmitted infections.”

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