PneumoniaPhase 4NCT00304382
Humoral Determinants of Immunity to Pneumococcal Infection
A Phase 4 study testing Prevnar and Pneumovax in people with Pneumonia and Pneumococcal Infections, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there are differences in the level of antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such antibody after vaccinating patients who have recovered from pneumococcal pneumonia with pneumococcal polysaccharide vaccine (Pneumovax) or… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Pneumococcal Infections, Infections, Streptococcus Pneumoniae
- What is being tested?
- Prevnar and Pneumovax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2003to 1 Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of pneumococcal pneumonia
- Age matched controls who have not had pneumococcal pneumonia
- Patients enrolled must be veterans
Who cannot join
- Patients who do not have the diagnosis of pneumococcal pneumonia based on a clinical syndrome that is consistent with pneumonia and the finding of pneumococcus in blood or sputum or any other sterile site will be excluded
- Women of child-bearing age will be excluded
- Patients who have had a prior reaction to pneumococcal vaccine that they describe as 'severe' will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
The purpose of this study is to determine whether there are differences in the level of antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such antibody after vaccinating patients who have recovered from pneumococcal pneumonia with pneumococcal polysaccharide vaccine (Pneumovax) or conjugate pneumococcal vaccine (Prevnar).
Read the detailed description
Streptococcus pneumoniae (pneumococcus) is the most common cause of pneumonia leading to hospitalization of adults. Resistance to infection is generally thought to be highly associated with antibody to the capsular polysaccharide (CPS). Most people who develop pneumococcal pneumonia lack antibody to the capsule of the infecting type. We have previously shown that some persons develop this infection despite the presence of antibody to the capsular polysaccharide of the infecting type. When such antibody is found, it tends to be poorly functional (DM Musher et al, J Infect Dis 182:158-167, 2000) in that it opsonizes pneumococci poorly for phagocytosis by human white blood cells in vitro, and protects mice poorly or not at all against challenge with the infecting organism.
About 20% of patients with pneumococcal pneumonia in our previous study had been vaccinated with the only vaccine currently in use for adults, namely 23-valent pneumococcal vaccine (Pneumovax [Merck]). This product consists of purified capsular polysaccharides from 23 different serotypes of S. pneumoniae. During the past two years, with more active vaccination programs at our hospital, the proportion of pneumococcal pneumonia patients who have been vaccinated has increased to about 60%. Clearly, the vaccine has not provided a full degree of protection.
After many years of study, including one involving nearly 40,000 children in the Kaiser Permanent health care system, a new form of pneumococcal vaccine was released. In this vaccine, Prevnar [Wyeth-Lederle], capsular polysaccharide from 7 of the most common pneumococcal types were conjugated to a protein that closely resembles diphtheria toxoid. There have been suggestions that Prevnar stimulates antibody in some subjects who fail to respond to Pneumovax (DM Musher et al, Clin Infect Dis 27:1487-1490, 1998) and also that the resulting antibody may more effectively opsonize bacteria for phagocytosis.
We propose to focus the present research on persons who develop pneumococcal pneumonia, a group that is regarded as being at very high risk of reinfection. Persons who recover from pneumococcal pneumonia will be randomized to vaccination revaccination with Pneumovax or vaccination with Prevnar. These studies will clarify whether administration of protein conjugate pneumococcal vaccine stimulates antibody in patients with pneumonia who failed to respond to prior vaccination or stimulates better functional antibody in those who have previously responded with antibody that is only poorly functional.
Our laboratory and others have shown that Prevnar successfully immunizes adults (Ahmed et al, J Infect Dis 173:83-90, 1996). The vaccine is not officially recommended for adults because antibody levels are the same after Prevnar as after Pneumovax. Such antibody may be more functional; this has not yet been determined. Prevnar contains only 7 antigens whereas Pneumovax contains 23 antigens; thus, it would be less desirable, in general, to administer this vaccine instead of Pneumovax. However, in patients who have developed pneumonia despite having received Pneumovax, the conjugate vaccine may offer an opportunity to stimulate production of effective antibody. In the proposed research, all participants will eventually receive both Pneumovax and Prevnar.
- Being tested
- Prevnar, Pneumovax
- Keywords
- Pneumococcus, Pneumococcal pneumonia
- Medical subject headings
- Pneumonia, Pneumococcal Infections, Pneumonia, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrevnarBiological
Also called Pneumococcal 7-Valent Conjugate Vaccine
0.5 ml IM into each deltoid muscle one time (or two in group PCV-PCV)
PneumovaxBiological
Also called Pneumococcal Vaccine Polyvalent
0.5 ml IM one time
| Study group | Role | What they receive |
|---|---|---|
| PPV-PCV | Experimental | Patients receive Pneumovax, and 6 months later Prevnar Receives: Biological: Prevnar; Biological: Pneumovax |
| PCV-PPV | Experimental | Patients receive Prevnar, and 6 months later Pneumovax Receives: Biological: Prevnar; Biological: Pneumovax |
| PCV-PCV | Experimental | Patients receive Prevnar, and 6 months later Prevnar again Receives: Biological: Prevnar |
| PCV only | Experimental | Patients receive Prevnar only Receives: Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic activity
Measured: 30 days
Secondary outcomes (1)
Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic capacity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study start1 Jan 2003
- Primary completion1 Sep 2006
- Study completion1 Jun 2012
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.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Daniel M Musher, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304382
- Sponsor's protocol ID
- INDB-013-05F
- Other IDs
- H-16562
- Status last verified
- Sep 2017
- First submitted
- 16 Mar 2006
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral Determinants of Immunity to Pneumococcal Infection
- ClinicalTrials.gov ID
- NCT00304382
- Acronym / sponsor ID
- INDB-013-05F
- Keywords
- Pneumococcus, Pneumococcal pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Sep 2006 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 17 Mar 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.
The purpose of this study is to determine whether there are differences in the level of antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such antibody after vaccinating patients who have recovered from pneumococcal pneumonia with pneumococcal polysaccharide vaccine (Pneumovax) or conjugate pneumococcal vaccine (Prevnar).
Detailed description
Streptococcus pneumoniae (pneumococcus) is the most common cause of pneumonia leading to hospitalization of adults. Resistance to infection is generally thought to be highly associated with antibody to the capsular polysaccharide (CPS). Most people who develop pneumococcal pneumonia lack antibody to the capsule of the infecting type. We have previously shown that some persons develop this infection despite the presence of antibody to the capsular polysaccharide of the infecting type. When such antibody is found, it tends to be poorly functional (DM Musher et al, J Infect Dis 182:158-167, 2000) in that it opsonizes pneumococci poorly for phagocytosis by human white blood cells in vitro, and protects mice poorly or not at all against challenge with the infecting organism.
About 20% of patients with pneumococcal pneumonia in our previous study had been vaccinated with the only vaccine currently in use for adults, namely 23-valent pneumococcal vaccine (Pneumovax [Merck]). This product consists of purified capsular polysaccharides from 23 different serotypes of S. pneumoniae. During the past two years, with more active vaccination programs at our hospital, the proportion of pneumococcal pneumonia patients who have been vaccinated has increased to about 60%. Clearly, the vaccine has not provided a full degree of protection.
After many years of study, including one involving nearly 40,000 children in the Kaiser Permanent health care system, a new form of pneumococcal vaccine was released. In this vaccine, Prevnar [Wyeth-Lederle], capsular polysaccharide from 7 of the most common pneumococcal types were conjugated to a protein that closely resembles diphtheria toxoid. There have been suggestions that Prevnar stimulates antibody in some subjects who fail to respond to Pneumovax (DM Musher et al, Clin Infect Dis 27:1487-1490, 1998) and also that the resulting antibody may more effectively opsonize bacteria for phagocytosis.
We propose to focus the present research on persons who develop pneumococcal pneumonia, a group that is regarded as being at very high risk of reinfection. Persons who recover from pneumococcal pneumonia will be randomized to vaccination revaccination with Pneumovax or vaccination with Prevnar. These studies will clarify whether administration of protein conjugate pneumococcal vaccine stimulates antibody in patients with pneumonia who failed to respond to prior vaccination or stimulates better functional antibody in those who have previously responded with antibody that is only poorly functional.
Our laboratory and others have shown that Prevnar successfully immunizes adults (Ahmed et al, J Infect Dis 173:83-90, 1996). The vaccine is not officially recommended for adults because antibody levels are the same after Prevnar as after Pneumovax. Such antibody may be more functional; this has not yet been determined. Prevnar contains only 7 antigens whereas Pneumovax contains 23 antigens; thus, it would be less desirable, in general, to administer this vaccine instead of Pneumovax. However, in patients who have developed pneumonia despite having received Pneumovax, the conjugate vaccine may offer an opportunity to stimulate production of effective antibody. In the proposed research, all participants will eventually receive both Pneumovax and Prevnar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PPV-PCV | Experimental | Biological: Prevnar, Biological: PneumovaxPatients receive Pneumovax, and 6 months later Prevnar |
| PCV-PPV | Experimental | Biological: Prevnar, Biological: PneumovaxPatients receive Prevnar, and 6 months later Pneumovax |
| PCV-PCV | Experimental | Biological: PrevnarPatients receive Prevnar, and 6 months later Prevnar again |
| PCV only | Experimental | Biological: PrevnarPatients receive Prevnar only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of pneumococcal pneumonia
- Age matched controls who have not had pneumococcal pneumonia
- Patients enrolled must be veterans
Key exclusion criteria (3 listed)
- Patients who do not have the diagnosis of pneumococcal pneumonia based on a clinical syndrome that is consistent with pneumonia and the finding of pneumococcus in blood or sputum or any other sterile site will be excluded
- Women of child-bearing age will be excluded
- Patients who have had a prior reaction to pneumococcal vaccine that they describe as 'severe' will be excluded
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 |
|---|---|---|
| PrevnarAlso: Pneumococcal 7-Valent Conjugate Vaccine0.5 ml IM into each deltoid muscle one time (or two in group PCV-PCV) | Biological | PCV only, PCV-PCV, PCV-PPV, PPV-PCV |
| PneumovaxAlso: Pneumococcal Vaccine Polyvalent0.5 ml IM one time | Biological | PCV-PPV, PPV-PCV |
Primary outcome
Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic activity
Time frame: 30 days
1 secondary outcome
Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic capacity
Time frame: 6 months
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 5 Sep 2017.
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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.
Daniel M Musher principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
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 Prevnar and Pneumovax in people with Pneumonia and Pneumococcal Infections, run by VA Office of Research and Development 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 3 inclusion and 3 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 5 Sep 2017. 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?
Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic activity (time frame: 30 days). 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 5 Sep 2017.