HIV InfectionsPhase 2NCT00148824
Antibody Responses to Pneumococcal Vaccines Among HIV-infected Adults.
A Phase 2 study testing 7-valent pneumococcal conjugate vaccine (vaccine) and 23-valent pneumococcal conjugate vaccine (vaccine) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- 7-valent pneumococcal conjugate vaccine (vaccine) and 23-valent pneumococcal conjugate vaccine (vaccine)
- Type of treatment
- Vaccines
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2003to Jan 2006
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with proven HIV-1 infection
- Naïve or antiretroviral experienced
- CD4 cell count between 200 and 500/mm3
- Plasma HIV RNA load lower than 4 log10 copies/mL
- Signed written informed consent
Who cannot join
- Immunotherapy
- Immunization with the PPV within the past 5 years
- Splenectomy
- Use of intravenous immunoglobulin within the past 2 months
- Chemotherapy or radiation
- Any other vaccination within the past 2 months
Show all 9Show fewer
- Severe renal failure
- End-stage liver disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunological Efficacy of a Prime-boost Strategy Combining a 7-valent Pneumococcal Conjugate Vaccine (PCV) Followed by a 23-valent Pneumococcal Polysaccharide Vaccine (PPV) Versus PPV Alone in HIV-infected Adults. ANRS 114 PNEUMOVAC.
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.
Read the detailed description
Streptococcus pneumoniae (SP) is the major cause of bacterial infection in HIV-infected patients. The 23-valent pneumococcal polysaccharide (PPV) is poorly immunogenic in patients with CD4 below 500 cells/mm3. The purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (PCV), able to induce immunological memory, would improve immunogenicity against SP polysaccharides. 212 HIV-1 infected patients, with a CD4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: PCV at Week 0 followed by PPV at Week 4 or PPV alone at Week 4. Evaluation will be done at week 8. The primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.
- Conditions
- HIV Infections
- Being tested
- 7-valent pneumococcal conjugate vaccine (vaccine), 23-valent pneumococcal conjugate vaccine (vaccine)
- Keywords
- HIV infections, Pneumococcal vaccines, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent pneumococcal conjugate vaccine (vaccine)Biological
23-valent pneumococcal conjugate vaccine (vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients responders to 7 pneumococcal polysaccharides at W8
Secondary outcomes (4)
Persistence of antibody responses at W24 and W96
Clinical tolerance of pneumococcal vaccines at W8
Evolution of the CD4 count and plasma HIV RNA load
Immunological substudy (predictive factors of the antibody responses) at W24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionJan 2006
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Philippe Lesprit, MD, Principal investigator, Service d'Immunologie Clinique, Créteil, 94010, FranceGeneviève Chêne, MD, PhD, Study director, INSERM unité 593
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148824
- Sponsor's protocol ID
- ANRS 114 PNEUMOVAC
- Status last verified
- Mar 2008
- First submitted
- 7 Sep 2005
- Last updated
- 15 Jun 2026
- Results posted
- No
Publications
Lesprit P, Pedrono G, Molina JM, Goujard C, Girard PM, Sarrazin N, Katlama C, Yeni P, Morineau P, Delfraissy JF, Chene G, Levy Y; ANRS 114-Pneumovac Study Group. Immunological efficacy of a prime-boost pneumococcal vaccination in HIV-infected adults. AIDS. 2007 Nov 30;21(18):2425-34. doi: 10.1097/QAD.0b013e3282887e91.
PubMed 18025879Rabian C, Tschope I, Lesprit P, Katlama C, Molina JM, Meynard JL, Delfraissy JF, Chene G, Levy Y; ANRS 114 Pneumovac Study Group. Cellular CD4 T cell responses to the diphtheria-derived carrier protein of conjugated pneumococcal vaccine and antibody response to pneumococcal vaccination in HIV-infected adults. Clin Infect Dis. 2010 Apr 15;50(8):1174-83. doi: 10.1086/651418.
PubMed 20210645
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Efficacy of a Prime-boost Strategy Combining a 7-valent Pneumococcal Conjugate Vaccine (PCV) Followed by a 23-valent Pneumococcal Polysaccharide Vaccine (PPV) Versus PPV Alone in HIV-infected Adults. ANRS 114 PNEUMOVAC.
- ClinicalTrials.gov ID
- NCT00148824
- Acronym / sponsor ID
- ANRS 114 PNEUMOVAC
- Conditions
- HIV Infections
- Keywords
- HIV infections, Pneumococcal vaccines, Treatment Experienced, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 8 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.
Streptococcus pneumoniae is the major cause of bacterial infection in HIV-infected patients. The current pneumococcal vaccine is poorly efficacious in patients with a CD4 cell count lower than 500/mm3. This study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a CD4 cell count between 200 and 500/mm3.
Detailed description
Streptococcus pneumoniae (SP) is the major cause of bacterial infection in HIV-infected patients. The 23-valent pneumococcal polysaccharide (PPV) is poorly immunogenic in patients with CD4 below 500 cells/mm3. The purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (PCV), able to induce immunological memory, would improve immunogenicity against SP polysaccharides. 212 HIV-1 infected patients, with a CD4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: PCV at Week 0 followed by PPV at Week 4 or PPV alone at Week 4. Evaluation will be done at week 8. The primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at Week 8. Secondary endpoints include the persistence of antibody responses at Weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with proven HIV-1 infection
- Naïve or antiretroviral experienced
- CD4 cell count between 200 and 500/mm3
- Plasma HIV RNA load lower than 4 log10 copies/mL
- Signed written informed consent
Key exclusion criteria (9 listed)
- Immunotherapy
- Immunization with the PPV within the past 5 years
- Splenectomy
- Use of intravenous immunoglobulin within the past 2 months
- Chemotherapy or radiation
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 (vaccine) | Biological | – |
| 23-valent pneumococcal conjugate vaccine (vaccine) | Biological | – |
Primary outcome
Proportion of patients responders to 7 pneumococcal polysaccharides at W8
4 secondary outcomes
Persistence of antibody responses at W24 and W96
Clinical tolerance of pneumococcal vaccines at W8
Evolution of the CD4 count and plasma HIV RNA load
Immunological substudy (predictive factors of the antibody responses) at W24
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 15 Jun 2026.
- Results publication: PubMed 18025879Lesprit P, Pedrono G, Molina JM, Goujard C, Girard PM, Sarrazin N, Katlama C, Yeni P, Morineau P, Delfraissy JF, Chene G, Levy Y; ANRS 114-Pneumovac Study Group. Immunological efficacy of a prime-boost pneumococcal vaccination in HIV-infected adults. AIDS. 2007 Nov 30;21(18):2425-34. doi: 10.1097/QAD.0b013e3282887e91.
- Derived from this study: PubMed 20210645Rabian C, Tschope I, Lesprit P, Katlama C, Molina JM, Meynard JL, Delfraissy JF, Chene G, Levy Y; ANRS 114 Pneumovac Study Group. Cellular CD4 T cell responses to the diphtheria-derived carrier protein of conjugated pneumococcal vaccine and antibody response to pneumococcal vaccination in HIV-infected adults. Clin Infect Dis. 2010 Apr 15;50(8):1174-83. doi: 10.1086/651418.
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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.
Philippe Lesprit, MD principal investigator
Service d'Immunologie Clinique, Créteil, 94010, France
Geneviève Chêne, MD, PhD study director
INSERM unité 593
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7-valent pneumococcal conjugate vaccine (vaccine) and 23-valent pneumococcal conjugate vaccine (vaccine) in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 9 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 15 Jun 2026. 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 France. 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 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?
Proportion of patients responders to 7 pneumococcal polysaccharides at W8. 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 NCT00148824, 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 15 Jun 2026.