PneumoniaPhase 4NCT00371878
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection
A Phase 4 study testing 7-valent pneumococcal conjugate vaccine (Prevnar) in people with Pneumonia and Meningitis, run by Royal Liverpool University Hospital at 1 site in Malawi.
Trial summary
Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Meningitis, Invasive Pneumococcal Disease
- What is being tested?
- 7-valent pneumococcal conjugate vaccine (Prevnar)
- Type of treatment
- Vaccines
- How many people
- 40 participants
- Where
- 1 siteMalawi
- Study dates
- Feb 2003to Oct 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy volunteer adults
Who cannot join
- pregnant, recent illness, previous vaccination, asthma
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Wellcome Trust Laboratories and Dept of Medicine, Queen Elizabeth Central Hospital
Blantyre, BT3
About this study
Official title: Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.
Read the detailed description
We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection[32] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.
- Conditions
- Pneumonia, Meningitis, Invasive Pneumococcal Disease, HIV
- Being tested
- 7-valent pneumococcal conjugate vaccine (Prevnar)
- Keywords
- Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine
- Medical subject headings
- Pneumonia, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent pneumococcal conjugate vaccine (Prevnar)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunoglobulin titres in bronchoalveolar fluid
Secondary outcomes (3)
Immunoglobulin titres in serum
Lung lymphocyte phenotype
HIV viral load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startFeb 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Royal Liverpool University Hospital
- Sponsor type
- Other government
- Collaborators
- Kamuzu University of Health Sciences, Liverpool School of Tropical Medicine, Wellcome Trust
- Investigators
- Neil French, PhD FRCP, Study director, Karonga Prevention Study, London School of Tropical Medicine and HygienceStephen B Gordon, MA MD FRCP, Principal investigator, Liverpool School of Tropical Medicine, Liverpool, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371878
- Sponsor's protocol ID
- BAL0601
- Other IDs
- ISRCTN54494731, ISRCTN 061230, P99/00/101, P99/00/102
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2006
- Last updated
- 8 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of Lung and Serum Immunoglobulin Responses to 7-Valent Pneumococcal Conjugate Vaccine in HIV Infected and Non-HIV Infected Malawian Adults
- ClinicalTrials.gov ID
- NCT00371878
- Acronym / sponsor ID
- BAL0601
- Conditions
- Pneumonia, Meningitis, Invasive Pneumococcal Disease, HIV
- Keywords
- Vaccine, Lung, Bronchoalveolar lavage, Lymphocyte, Immunoglobulin, HIV, Streptococcus pneumoniae, Conjugate vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Royal Liverpool University HospitalOther government
- Collaborators
- Kamuzu University of Health Sciences, Liverpool School of Tropical Medicine, Wellcome Trust
- Study start
- Feb 2003
- Study completion
- Oct 2003
- First posted
- 4 Sep 2006 (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.
Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.
Detailed description
We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection[32] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteer adults
Key exclusion criteria (1 listed)
- pregnant, recent illness, previous vaccination, asthma
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 |
|---|---|---|
| 7-valent pneumococcal conjugate vaccine (Prevnar) | Biological | – |
Primary outcome
Immunoglobulin titres in bronchoalveolar fluid
3 secondary outcomes
Immunoglobulin titres in serum
Lung lymphocyte phenotype
HIV viral load
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 8 Aug 2008.
- The Malawi-Liverpool-Wellcome Programme of Clinical Tropical Research has been established for 10 years.Link provided by the sponsor.
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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.
Neil French, PhD FRCP study director
Karonga Prevention Study, London School of Tropical Medicine and Hygience
Stephen B Gordon, MA MD FRCP principal investigator
Liverpool School of Tropical Medicine, Liverpool, UK
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 7-valent pneumococcal conjugate vaccine (Prevnar) in people with Pneumonia and Meningitis, run by Royal Liverpool University Hospital at 1 site in Malawi.
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 1 inclusion and 1 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 8 Aug 2008. 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 Malawi. 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?
Immunoglobulin titres in bronchoalveolar fluid. 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 8 Aug 2008.