Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001605
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Vaccination for Middle Ear Infection
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study to Evaluate the Safety and Immunogenicity of a Nontypeable Haemophilus Influenzae Vaccine for Otitis Media
Status:
COMPLETED
Status Verified Date:
2000-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-DC-0114 | None | None | None |