Haemophilus Influenzae Type BPhase 4NCT00153556
Study to Eliminate Hib Carriage in Rural Alaska Native Villages
A Phase 4 study testing Hib conjugate vaccine (HbOC, Wyeth Vaccines) in people with Haemophilus Influenzae Type B and Carrier State, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type B, Carrier State
- What is being tested?
- Hib conjugate vaccine (HbOC, Wyeth Vaccines)
- Type of treatment
- Vaccines
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Nov 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All village residents are eligible for Hib colonization survey
- All residents of selected villages eligible for vaccine study except as noted below.
Who cannot join
- For receipt of vaccine:
- history of allergic reaction to Hib vaccine or components
- Age < 24 months and not due for Hib vaccine according to childhood immunization schedule
- Age > 24 months and have received HIb vaccine within past year
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
CDC Arctic Investigations Program
Anchorage, Alaska, 99508
About this study
Official title: A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages
Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.
The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.
Read more
Secondary objectives include:
- Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
- Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.
Read the detailed description
This was a pilot intervention to assess the feasibility of using Hib conjugate vaccine to eliminate Hib carriage in rural Alaska villages, with three villages to serve as a comparison group. WE performed community-wide surveys of Hib carriage by recruiting volunteers for throat cultures to establish a baseline rate of Hib carriage for each community. Then Hib carriers were offered chemoprophylaxis to clear Hib from their throats. In the vaccine intervention communities, a single dose of Hib conjugate vaccine was offered to persons of all ages. This was followed by a second community-wide Hib carriage survey after one year to assess the effectiveness of the intervention.
- Conditions
- Haemophilus Influenzae Type B, Carrier State
- Being tested
- Hib conjugate vaccine (HbOC, Wyeth Vaccines)
- Keywords
- Haemophilus influenza type B, Carrier state, Bacterial Vaccines, Anti-PRP antibody, Antibody avidity, Serum bacteriocidal antibody, American Indians/Alaska Natives, Case control study, Adult vaccines
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib conjugate vaccine (HbOC, Wyeth Vaccines)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in community-wide oropharyngeal Hib colonization one year after administration of a single dose of Hib vaccine to all willing community members in 3 villages vs. change in HIb colonization in 3 village where Hib vaccine was used routinely
Secondary outcomes (3)
- Safety of HIb vaccine given to adults
- Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
- Risk factors for Hib colonization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2001
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus Influenzae Type BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- CDC-Arctic Investigations Program, Alaska Native Tribal Health Consortium, Yukon Kuskokwim Health Corporation, Alaska State Public Health Laboratories, National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- Thomas W Hennessy, MD,MPH, Principal investigator, Centers for Disease Control and Prevention-Arctic Investigations Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153556
- Sponsor's protocol ID
- CDC-NCID-2961
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages
- ClinicalTrials.gov ID
- NCT00153556
- Acronym / sponsor ID
- CDC-NCID-2961
- Conditions
- Haemophilus Influenzae Type B, Carrier State
- Keywords
- Haemophilus influenza type B, Carrier state, Bacterial Vaccines, Anti-PRP antibody, Antibody avidity, Serum bacteriocidal antibody, American Indians/Alaska Natives, Case control study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- CDC-Arctic Investigations Program, Alaska Native Tribal Health Consortium, Yukon Kuskokwim Health Corporation, Alaska State Public Health Laboratories, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2001
- Study completion
- Nov 2003
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.
The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.
Secondary objectives include:
- Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
- Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.
Detailed description
This was a pilot intervention to assess the feasibility of using Hib conjugate vaccine to eliminate Hib carriage in rural Alaska villages, with three villages to serve as a comparison group. WE performed community-wide surveys of Hib carriage by recruiting volunteers for throat cultures to establish a baseline rate of Hib carriage for each community. Then Hib carriers were offered chemoprophylaxis to clear Hib from their throats. In the vaccine intervention communities, a single dose of Hib conjugate vaccine was offered to persons of all ages. This was followed by a second community-wide Hib carriage survey after one year to assess the effectiveness of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All village residents are eligible for Hib colonization survey
- All residents of selected villages eligible for vaccine study except as noted below.
Key exclusion criteria (5 listed)
- For receipt of vaccine:
- history of allergic reaction to Hib vaccine or components
- Age < 24 months and not due for Hib vaccine according to childhood immunization schedule
- Age > 24 months and have received HIb vaccine within past year
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hib conjugate vaccine (HbOC, Wyeth Vaccines) | Biological | – |
Primary outcome
Change in community-wide oropharyngeal Hib colonization one year after administration of a single dose of Hib vaccine to all willing community members in 3 villages vs. change in HIb colonization in 3 village where Hib vaccine was used routinely
3 secondary outcomes
- Safety of HIb vaccine given to adults
- Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
- Risk factors for Hib colonization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas W Hennessy, MD,MPH principal investigator
Centers for Disease Control and Prevention-Arctic Investigations Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hib conjugate vaccine (HbOC, Wyeth Vaccines) in people with Haemophilus Influenzae Type B and Carrier State, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in community-wide oropharyngeal Hib colonization one year after administration of a single dose of Hib vaccine to all willing community members in 3 villages vs. change in HIb colonization in 3 village where Hib vaccine was used routinely. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.