Needle-Free Vaccine for Ear Infections Could Also Help Reduce Use of Antibiotics

Newswise — COLUMBUS, Ohio – Some types of ear infections may one day be as rare as polio and smallpox thanks to a vaccine that's being developed by a team of researchers at Nationwide Children's Hospital. The vaccine – which targets the bacteria responsible for nearly one half of all ear infections – won't be delivered by a needle jab, but absorbed through the skin via a small, dime-sized patch.

"For a child, a non-needle vaccine has obvious benefits, but our research also shows that delivering the therapy through the skin sets off beneficial immune responses we might not see otherwise," said Laura Novotny, Chief Research Associate at The Research Institute at Nationwide Children's.

The team's latest animal study data, published in Vaccine, shows that when the experimental vaccine is applied to the outer ear, it appears to pack a one-two punch against nontypeable Haemophilus influenzae (NTHI), attacking key parts of the bacteria's defenses and kick-starting the body's own immune system to help clear out the infection.

This dual mechanism helps explain earlier animal researchconducted by the team that showed the vaccine could be used as a either a preventative or a treatment for ear infections, which are commonly treated with antibiotics. However, NTHI bacteria build biofilms, sticky protective covers that evade antibiotics and allow the bacteria to flourish in the middle ear, nasal passages and lungs to cause repeat infections.

"There are kids that have seven or eight ear infections before their first birthday, and these chronic infections can cause language and developmental delays. To have an option that could help break the reinfection cycle and reduce antibiotic use is significant," said Novotny who is also the study's co-author.

The experimental therapeutic appears to target key proteins used by the bacteria to build biofilms and cling to the cells lining the middle ear. The investigators observed the vaccine helped the body mount a local defense that zeroed in on those proteins, and also rallied systemic molecular defense mechanisms that helped further eliminate the infection.

"We think it's the first time anyone has shown that a topical application of an agent can trigger both a local and systemic immune response against ear infections caused by NTHI," said Novotny, who received a grant in 2012 to help refine the development of an adhesive patch from the Center for Clinical and Translational Science (CCTS), an NIH-supported research partnership between The Ohio State University and Nationwide Children's.

The vaccine research team, led by Lauren Bakaletz, PhD, Director of the Center for Microbial Pathogenesis at The Research Institute at Nationwide Children's, has been collaborating with John Clements, PhD of Tulane University for several years to identify and exploit weaknesses in the NTHI bacterial cell structure to create a vaccine. Bakaletz is considered one of the nation's foremost experts in the underlying molecular mechanisms of microbial infections of the respiratory tract and microbial biofilms.

"Recent studies indicate that a few of the vaccines that kids currently get may offer some protection, but with more than 700 million ear infections in the US each year, and the growing concern over antibiotic resistance, clearly there are opportunities to develop something better," said Bakaletz, who is also a professor of Pediatrics and of Otolaryngology at the Ohio State College of Medicine.

Middle ear infections are very common in children under the age of four, and each year, an estimated one billion cases of acute and chronic infections occur worldwide. While ear infections aren't typically deadly in developed countries, they cause quality of life and economic problems that have lifelong impacts including language and developmental delays. The researchers are hopeful that the simplicity of the patch could make it an ideal candidate for a global vaccination program.

"The patch could be truly impactful in developing countries, where costs for widespread vaccinations can be an issue," said Novotny. "Syringes and trained medical professionals who can administer a vaccine can be expensive – but the patch could reduce material and resource costs significantly."

Ultimately, researchers envision creating a vaccine patch similar to the kind placed behind the ear to prevent motion sickness. As a vaccine for children, the patches would be stuck behind both ears or on the back of the neck, and possibly worn for just one day. Novotny says that so far, there have been no side effects seen in animal subjects that have worn the patch.

The team hopes to begin testing the skin patch will be ready for testing in humans in the not too distant future, and to use the insights on NTHI bacteria they've observed to help inform other research on biofilms and infectious disease.

# # #

About The Ohio State University Center for Clinical and Translational Science
Dedicated to turning the scientific discoveries of today into the life-changing health innovations of tomorrow, The Ohio State University Center for Clinical and Translational Science (CCTS) is a collaboration of experts including scientists and clinicians from six Ohio State Health Science Colleges, Ohio State's Wexner Medical Center and College of Medicine, and Nationwide Children's Hospital. Funded by a multi-year Clinical and Translational Science Award (CTSA) from the National Institutes of Health, OSU CCTS provides financial, organizational and educational support to biomedical researchers as well as opportunities for community members to participate in credible and valuable research. The CCTS is led by Rebecca Jackson, M.D., Director of the CCTS and associate dean of research at Ohio State. For more information, visit

About Nationwide Children's Hospital
Ranked 7th of only 12 children's hospitals in U.S.News & World Report's 2012-13 "America's Best Children's Hospitals" and among the Top 10 on Parents magazine's 2013 "Best Children's Hospitals" lists, Nationwide Children's Hospital is one of the nation's largest not-for-profit freestanding pediatric healthcare networks providing care for infants, children, adolescents and adult patients with congenital disease. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children's Hospital faculty train the next generation of pediatricians, scientists and pediatric specialists. The Research Institute at Nationwide Children's Hospital is one of the top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational and health services research at Nationwide Children's Hospital. In June 2012, the hospital celebrated completion of the largest pediatric expansion project in United States history including the addition of a third research building. All three research buildings include approximately 525,000 square feet dedicated to research. More information is available

About the Clinical and Translational Science Awards 
Launched in 2006 by the NIH, and currently residing in the National Center for the Advancement of Translational Sciences (NCATS), the Clinical and Translational Science Awards (CTSA) program created academic homes for clinical and translational science at research institutions across the country. The CTSA's primary goal is to accelerate discoveries towards better human health by speeding up the time it takes for basic science to turn into useable therapeutics and to train the next generation of clinicians and translational researchers.

The Ohio State University Center for Clinical and Translational Science (CCTS) is funded by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program (grants 8UL1TR000090-05, 8KL2TR000112-05, and 8TL1TR000091-05) The CTSA program is led by the NIH's National Center for Advancing Translational Sciences (NCATS). The content of this release is solely the responsibility of the CCTS and does not necessarily represent the official views of the NIH.