Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vaccination for Middle Ear Infection

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001605
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: April 2000
  Purpose

Acute otitis media (OM) and OM with effusion are common childhood diseases. Otitis media is a condition marked by inflammation of the middle ear. Otitis media with effusion typically means a long-term (chronic) middle ear inflammation with secretion of fluid into the middle ear due to the blockage of the canal leading from the middle ear to the mouth (eustachian tube). The fluid involved can be sterile (no organisms) or infected with disease causing organisms, such as bacteria or viruses.

Nontypeable Haemophilus influenzae (NTHi) is a bacteria that is one of the leading causes of OM and respiratory infections in older people. NTHi carry substances on their surface called antigens. When antigens come into contact with the right kinds of cells in the body, an immune reaction is caused. This reaction is often the symptoms of sickness that a patient feels. One of the major antigens on the surface of NTHi is called lipooligosaccharide (LOS).

In order for the body to fight off the attack of antigens, it creates substances called antibodies. Antibodies counter the action of antigens and make the bacteria harmless. However, the immune system must learn how to make the right antibodies for the right antigens. This is done by giving vaccines.

Vaccines can contain a small amount or an inactive form of an antigen. Once the immune system recognizes the antigen it can start making antibodies to prevent sickness if it is ever exposed to the antigen again. Presently there are no vaccines for NTHi.

One of the reasons why there is no vaccine for NTHi is because the antigen, LOS, is very toxic when given to humans. Researchers have tried to make the antigen less dangerous by removing the toxic effects. It is referred to as dLOS. Unfortunately, dLOS is unable to start antibody production.

However, researchers have found that by combining dLOS with another vaccine for tetanus (tetanous toxoid), they were able to stimulate the immune system to create antibodies in laboratory animals. These laboratory animals were protected against NTHi infections and otitis media (OM).

Researchers would like to test the effectiveness and safety of dLOS-TT vaccine in adult humans. Their ultimate goal is to develop a vaccine for OM and respiratory infections caused by NTHi.


Condition Intervention Phase
Otitis Media
Biological: Nontypeable Haemophilus influenzae
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Safety and Immunogenicity of a Nontypeable Haemophilus Influenzae Vaccine for Otitis Media

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: May 1997
Estimated Study Completion Date: April 2001
Detailed Description:

Acute otitis media (OM) and OM with effusion are common childhood diseases. Nontypeable Haemophilus influenzae (NTHi) is a leading cause of OM and respiratory infections in older individuals. Currently, there is no vaccine for NTHi infection. Studies indicate that serum bactericidal antibodies are associated with protection from NTHi infection. We predict that serum antibodies with bactericidal activity to the lipooligosaccharide (LOS), a major surface antigen and virulence factor of NTHi, will confer immunity to this pathogen. LOS of NTHi is too toxic to administer to humans and detoxified LOS (dLOS) is not immunogenic, probably due to its low molecular weight. In order to improve its immunogenicity, the dLOS was convalently bound to tetanus toxoid (TT) using a clinically relevant scheme of vaccination, elicited bactericidal antibodies to LOS in an in vivo model. This investigational vaccine also showed protection against infection in a chinchilla otitis media model. We propose to evaluate the safety and immunogenicity of this dLOS-TT vaccine in adults (Phase I). Our goal is to develop a vaccine for OM and respiratory infections caused by NTHi.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Healthy volunteers between ages 18 and 35 years.

Not pregnant or planning to become pregnant in next six months.

HIV negative.

Hepatitis B Negative.

No chronic Respiratory Tract Infections.

No history of abnormal immune system.

No severe or multiple allergies.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001605

Locations
United States, Maryland
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001605     History of Changes
Other Study ID Numbers: 970114, 97-DC-0114
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Conjugate Vaccine
Detoxified Lipooligosaccharide
Tetanus Toxoid
Normal Volunteers

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014