Pneumococcal InfectionsPhase 1/2NCT00137605
Early Versus Delayed Pneumococcal Vaccination in HIV
A Phase 1/2 study testing Pneumovax and Prevnar in people with Pneumococcal Infections, run by CIHR Canadian HIV Trials Network at 14 sites in Canada.
Trial summary
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Pneumovax and Prevnar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 14 sitesCanada
- Study dates
- Sep 2004to Oct 2007
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive
- Between 18 and 65 years of age
- Have a CD4 cell count below 200 cells/mm3
- Willing to begin/change antiretroviral therapy
- Willing and able to provide informed consent
Who cannot join
- Pregnant or breastfeeding
- Have had previous pneumococcal vaccination
- Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
- Have hypersensitivity to components of either vaccine
- Have acute feverish illness at the time of vaccination
- Have had splenectomy (removal of the spleen)
- Have received treatment with IVIG within the last 6 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
Victoria General
Halifax, Nova Scotia
McMaster University
Hamilton, Ontario
Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 1T2
St. Joseph's Hospital
London, Ontario
Montreal Chest/Royal-Victoria
Montreal, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Centre Hospitalier Universitaire de Laval
Ste-Foy, Quebec
Sunnybrook
Toronto, Ontario
Toronto General
Toronto, Ontario
Downtown IDC
Vancouver, British Columbia
St. Paul's Hospital
Vancouver, British Columbia
Moncton Hospital
Windsor, New Brunswick
Metropolitan Hospital
Windsor, Ontario
St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Official title: A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.
Read the detailed description
A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.
- Conditions
- Pneumococcal Infections
- Being tested
- Pneumovax, Prevnar
- Keywords
- HIV, HIV Infections
- Medical subject headings
- Pneumococcal Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumovaxBiological
PrevnarBiological
| Study group | Role | What they receive |
|---|---|---|
| Pneumovax/immediate | Experimental | Not described Receives: Biological: Pneumovax |
| Pneumovax/delayed | Experimental | Not described Receives: Biological: Pneumovax |
| Prevnar/immediate | Experimental | Not described Receives: Biological: Prevnar |
| Prevnar/delayed | Experimental | Not described Receives: Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serotypes to which a response is found
A response is defined as a doubling in antibody titer at 1 month compared to baseline.
Secondary outcomes (5)
Antibody response at 6 months and one year
Changes in viral load 3 months post immunization
Adverse events
Overall incidence of invasive pneumococcal disease
Incidence of invasive pneumococcal disease between vaccines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2004
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIHR Canadian HIV Trials Network
- Sponsor type
- Research network
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Walter Schlech, MD, Principal investigator, Victoria General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137605
- Sponsor's protocol ID
- CTN 147
- Other IDs
- Control # 078760, File # 9427-C1574-34C
- Status last verified
- Feb 2014
- First submitted
- 26 Aug 2005
- Last updated
- 13 Feb 2014
- Results posted
- No
Publications
Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6.
PubMed 23535358Kimby E, Schar S, Pirosa MC, Vanazzi A, Mey UM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Krasniqi F, Voegeli M, Novak U, Zander T, Bersvendsen H, Mamot C, Mingrone W, Stathis A, Dirnhofer S, Hayoz S, Ostenstad B, Zucca E. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840.
PubMed 39883948
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Efficacy of Pneumococcal Vaccine in HIV Patients: Delayed Versus Immediate Immunization
- ClinicalTrials.gov ID
- NCT00137605
- Acronym / sponsor ID
- CTN 147
- Conditions
- Pneumococcal Infections
- Keywords
- HIV, HIV Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- CIHR Canadian HIV Trials NetworkResearch network
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2004
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Aug 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.
The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.
Detailed description
A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pneumovax/immediate | Experimental | Biological: Pneumovax |
| Pneumovax/delayed | Experimental | Biological: Pneumovax |
| Prevnar/immediate | Experimental | Biological: Prevnar |
| Prevnar/delayed | Experimental | Biological: Prevnar |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-positive
- Between 18 and 65 years of age
- Have a CD4 cell count below 200 cells/mm3
- Willing to begin/change antiretroviral therapy
- Willing and able to provide informed consent
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Have had previous pneumococcal vaccination
- Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
- Have hypersensitivity to components of either vaccine
- Have acute feverish illness at the time of vaccination
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 |
|---|---|---|
| Pneumovax | Biological | Pneumovax/delayed, Pneumovax/immediate |
| Prevnar | Biological | Prevnar/delayed, Prevnar/immediate |
Primary outcome
Number of serotypes to which a response is found
A response is defined as a doubling in antibody titer at 1 month compared to baseline.
5 secondary outcomes
Antibody response at 6 months and one year
Changes in viral load 3 months post immunization
Adverse events
Overall incidence of invasive pneumococcal disease
Incidence of invasive pneumococcal disease between vaccines
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 13 Feb 2014.
- Results publication: PubMed 23535358Slayter KL, Singer J, Lee TC, Kayhty H, Schlech WF. Immunization against pneumococcal disease in HIV-infected patients: conjugate versus polysaccharide vaccine before or after reconstitution of the immune system (CTN-147). Int J STD AIDS. 2013 Mar;24(3):227-31. doi: 10.1177/0956462412472450. Epub 2013 May 6.
- Derived from this study: PubMed 39883948Kimby E, Schar S, Pirosa MC, Vanazzi A, Mey UM, Rauch D, Wahlin BE, Hitz F, Hernberg M, Johansson AS, de Nully Brown P, Hagberg H, Ferreri AJM, Krasniqi F, Voegeli M, Novak U, Zander T, Bersvendsen H, Mamot C, Mingrone W, Stathis A, Dirnhofer S, Hayoz S, Ostenstad B, Zucca E. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update. Blood Adv. 2025 Apr 8;9(7):1712-1719. doi: 10.1182/bloodadvances.2024014840.
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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.
Walter Schlech, MD principal investigator
Victoria General Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pneumovax and Prevnar in people with Pneumococcal Infections, run by CIHR Canadian HIV Trials Network at 14 sites in Canada.
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 5 inclusion and 7 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of serotypes to which a response is found. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137605, which also lists 2 linked publications.
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 13 Feb 2014.