Vaccination for Middle Ear Infection

NCT00001605 | Completed Phase 1

• 2 other identifiers: 97011497-DC-0114
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otitis Media

Keywords

Conjugate Vaccine; Detoxified Lipooligosaccharide; Tetanus Toxoid; Normal Volunteers

Interventions

Nontypeable Haemophilus influenzae BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institute on Deafness and Other Communication Disorders (NIDCD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Phillips NJ, Apicella MA, Griffiss JM, Gibson BW. Structural characterization of the cell surface lipooligosaccharides from a nontypable strain of Haemophilus influenzae. Biochemistry. 1992 May 12;31(18):4515-26. doi: 10.1021/bi00133a019.

  PMID: 1581306 BACKGROUND

• Gu XX, Tsai CM, Ueyama T, Barenkamp SJ, Robbins JB, Lim DJ. Synthesis, characterization, and immunologic properties of detoxified lipooligosaccharide from nontypeable Haemophilus influenzae conjugated to proteins. Infect Immun. 1996 Oct;64(10):4047-53. doi: 10.1128/iai.64.10.4047-4053.1996.

  PMID: 8926067 BACKGROUND

• Gu XX, Sun J, Jin S, Barenkamp SJ, Lim DJ, Robbins JB, Battey J. Detoxified lipooligosaccharide from nontypeable Haemophilus influenzae conjugated to proteins confers protection against otitis media in chinchillas. Infect Immun. 1997 Nov;65(11):4488-93. doi: 10.1128/iai.65.11.4488-4493.1997.

  PMID: 9353024 BACKGROUND

MeSH Terms

Conditions

Otitis Media; Tetanus

Interventions

ompP2 protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: May 1, 1997
• Study Completion: April 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-04

Locations

US (1)