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NCT00001605 · ClinicalTrials.gov registry record · Phase 1
Vaccination for Middle Ear Infection
A Phase 1 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00001605: Completed Phase 1 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
NCT00001605 is a Phase 1 study that has completed, run by National Institute on Deafness and Other Communication Disorders (NIDCD). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001605, a Phase 1 study, has completed, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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
Interventions
- BIOLOGICAL Nontypeable Haemophilus influenzae
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1997-05 |
| Est. Completion | 2001-04 |
| Phase | Phase 1 |
What the finished NCT00001605 record still lists
NCT00001605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Nontypeable Haemophilus influenzae is the first listed.
NCT00001605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001605 about?
NCT00001605 is a clinical study titled "Vaccination for Middle Ear Infection". 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 o...
What is the current status of trial NCT00001605?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 1997-05. Estimated completion is 2001-04.
What interventions are being tested in trial NCT00001605?
The interventions under investigation include: Nontypeable Haemophilus influenzae (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001605?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001605's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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