Possible New Vaccine for Ear and

Sinus Infection Treatment- Part 2

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immune system. Without causing an actual infection, vaccines introduce a weak version of a disease molecule to the system, which remembers it and is afterward primed should a natural version of the disease come along. Two types of immune system cells, T cells and antibodies, enable the system to “remember” bacteria, and will be watched closely during the current study.

 Once researchers confirm the kind of immune response needed to achieve protection, they can choose for inclusion in the vaccine the bacterial proteins that make that happen. The human immune system reacts, not to the presence of a whole bacterial cell, but instead to specific proteins on the surface of the bacterium that reveal its identity as an invader. Past research has revealed four such NTHi surface proteins as excellent candidates for inclusion in a multi-component protein vaccine. The next step is to conduct human cell and preclinical experiments on the four to confirm that they induce protection and belong in a proposed vaccine.

 An ideal vaccine would include four bacterial proteins, instead of one, to cut off a bacterial escape route. Bacteria reproduce and evolve (mutate) so rapidly that they can become unrecognizable to the immune system, even if strengthened by a single-protein vaccine. Based on the data collected and statistical analysis, researchers believe the multi-component vaccine will provide protection to the world population despite the tremendous variety in bacterial strains.

 To complete the study, the team will need to collect more than 5,500 samples of blood and mucus from 400 infants from the time they are two months old through their second year. The endeavor will require singular pediatric expertise, including the ability to perform tympanocentesis, where a needle is used to puncture the baby’s eardrum and remove fluid. To meet this challenge, the Medical Center is partnering with Pichichero’s practice, the Elmwood Pediatric Group, a private practice in Rochester, N.Y.  It has been part of pediatric clinical trials for 60 years, including those for the original polio vaccine, and has 20 years experience in otitis media studies.

 The new funding includes $500,000 from the Thrasher Foundation. Researchers also have applied for a $3.5 million grant from National Institute of Deafness and Communication Disorders.  The work continues for now based on past grants.

 In addition to pediatric expertise, the team attributes the grant success to decades of vaccine design experience at the Medical Center, including the work with Haemophilus influenza type b (Hib), Prevnar (pneumococcal 7-valent conjugate vaccine), acellular pertussis vaccines, meningococcal vaccines and combination vaccines.

 Accumulated expertise, funding and relationships have made the current project possible. For example, some preliminary work in this area was done at the Medical Center, and some elsewhere. Among the possible vaccine ingredients are bacterial proteins identified at other universities (e.g. Ohio State, University of Buffalo) and at pharma companies (e.g. GlaxoSmithKline).

 “For researchers to share their work with a lead institution for the final design phase means they believe a vaccine will come out of this project,” said Barbara Iglewski, Ph.D., chair and professor of Microbiology & Immunology at the Medical Center. “Their trust, and the urgent needs of children, leave us with a real sense of mission.”

 Hopefully this new vaccine will soon obtain the balance of the funding it is seeking and will go into clinical trials next year.  If successful, such a vaccine would be a huge leap forward for ear and sinus infection treatment.

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