Results of a new study show the feasibility and efficacy of preventing otitis media (OM), and potentially treat OM recurrence, through the simple use of a Band-Aid to deliver a vaccine targeted at one of the most common pathogens responsible for OM.1
These results build on prior work by researchers from the Research Institute at Nationwide Children’s Hospital, Columbus, Ohio, and Tulane University, New Orleans, Louisiana, aimed at developing a safe and broadly effective vaccine to prevent OM and potentially resolve existing OM. Previous work has focused on preclinical testing of the efficacy of 3 vaccines developed to target the ways that the common pathogen in OM—nontypeable Haemophilus influenzae (NTHI)—adheres to cells in the respiratory tract and builds biofilms.2 Delivering the vaccines via the skin, called transcutaneous immunization (TCI), was shown to be effective in an animal model.3,4
The current study focused on further testing the efficacy of TCI as a delivery system by using a polymicrobial experimental model that simulated closely how children typically develop OM; that is, first through an upper respiratory tract viral infection that then predisposes them to ascending bacterial infection from the nasopharynx (where biofilms form) to the middle ear.
The goal is to ultimately test this vaccine approach in the clinical setting, says senior author of the study Lauren O. Bakaletz, PhD, director, Center for Microbial Pathogenesis, professor of Pediatrics and Otolaryngology, the Research Institute at Nationwide Children’s Hospital and Ohio State University College of Medicine, Columbus, Ohio. “Developing a Band-Aid approach is an attempt to also develop a way to deliver these vaccines in a manner that does not require a syringe and needle,” she says.
Along with a being a way to reduce the number of “shots” a child needs to undergo to adhere to immunization schedules, Bakaletz emphasizes that TCI is also a “simple efficacious method that does not require medical personnel to deliver the vaccine so it can be used in regions of the world where resources might be limited.”
“We also wanted to see if we could harness the power of the skin as the body’s largest immune organ in our vaccine development efforts, and particularly the highly unique skin that sits right behind the ear,” Bakaletz says.
Preclinical evidence of efficacy using a polymicrobial model of disease
The current study examines further the efficacy of TCI to inoculate animals against OM. The study included 37 juvenile chinchillas without evidence of middle-ear infection divided into 4 cohorts each based on weight prior to undergoing a viral challenge with adenovirus serotype 1.
Each cohort then was given a different vaccine formulation via TCI: chimV4+dmLT, rsPilA+dmLT, IHF+dmLT, or rsPilA+IHF+dmLT. A Band-Aid with the vaccine formulation was affixed to the skin at the postauricular region of each chinchilla for 24 hours and then removed. Two doses of the vaccine were delivered, 1 week apart.
Two days following the second Band-Aid, all the chinchillas underwent a viral and bacterial challenge. Video otoscopy and tympanometry, procedures that are commonly used in the clinic to examine children with OM, were used to look for signs of OM.
The study found that this vaccination approach was clearly effective against OM.
“This approach worked and actually exceeded our original expectations,” says Bakaletz.
Given these results, Bakaletz is hopeful that a vaccine to prevent ear infections in children will become available “sooner rather than later.” She also expresses hope that such a vaccine will “not only prevent this highly prevalent pediatric disease, but also one that might provide a truly therapeutic outcome as well.”
These data are being presented at the 19th International Symposium on Recent Advances in Otitis Media in Queensland, Australia, June 4-8, 2017.
1. Novotny LA, Clements JD, Goodman SD, Bakaletz LO. Transcutaneous immunization with a Band-Aid prevents experimental otitis media in a polymicrobial model. Clin Vaccine Immunol. 2017;24(6):e00563-16. Available at: http://cvi.asm.org/content/24/6/e00563-16.abstract. Accessed June 6, 2017.
2. Novotny LA, Adams LD, Kang DR, et al. Epitope mapping immunodominant regions of the PilA protein of nonypeable Hameophilus influenzae (NTHI) to facilitate the design of two novel chimeric vaccine candidates. Vaccine. 2009;28(1):279-289.
3. Novotny LA, Clements JD, Bakaletz LO. Transcutaneous immunization as preventative and therapeutic regimens to protect against experimental otitis media due to nontypeable Haemophilus influenzae. Mucosal Immunol. 2011;4(4):456-467.
4. Novotny LA, Clements JD, Bakaletz LO. Therapeutic transcutaneous immunization with a Band-Aid vaccine resolves experimental otitis media. Clin Vaccine Immunol. 2015;22(8):867-874.