HIV InfectionPhase 4NCT03041051
Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients
A Phase 4 study testing PCV13 and PPV23 in people with HIV Infection, run by Aghia Sophia Children's Hospital of Athens.
Trial summary
The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- PCV13 and PPV23
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD4 T cell count >200cells/μl
- on ART
Who cannot join
- no previously recorded allergy to PCV, PPV23
- no intravenous immunoglobulin (IVIG) given within the previous 6 months
- no other vaccine given within the previous 6 months
About this study
Official title: Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.
- Conditions
- HIV Infection
- Being tested
- PCV13, PPV23
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Biological
PPV23Biological
| Study group | Role | What they receive |
|---|---|---|
| PCV13 | Experimental | Not described Receives: Biological: PCV13 |
| PPV23 | Experimental | Not described Receives: Biological: PPV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
Measured: One month post-PCV13, PPV23
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
Measured: One month post-PCV13, PPV23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startDec 2015
- Primary completion1 Mar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aghia Sophia Children's Hospital of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vana Spoulou, Aghia Sophia Children's Hospital of Athens
- Investigators
- Vana Spoulou, Principal investigator, Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041051
- Sponsor's protocol ID
- 51198eAS
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Farmaki PF, Chini MC, Mangafas NM, Tzanoudaki MT, Piperi CP, Lazanas MZ, Spoulou VS. Immunogenicity and Immunological Memory Induced by the 13-Valent Pneumococcal Conjugate Followed by the 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. J Infect Dis. 2018 Jun 5;218(1):26-34. doi: 10.1093/infdis/jiy135.
PubMed 29722823
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults
- ClinicalTrials.gov ID
- NCT03041051
- Acronym / sponsor ID
- 51198eAS
- Conditions
- HIV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aghia Sophia Children's Hospital of AthensUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 1 Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 2 Feb 2017 (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 the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV13 | Experimental | Biological: PCV13 |
| PPV23 | Experimental | Biological: PPV23 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CD4 T cell count >200cells/μl
- on ART
Key exclusion criteria (3 listed)
- no previously recorded allergy to PCV, PPV23
- no intravenous immunoglobulin (IVIG) given within the previous 6 months
- no other vaccine given within the previous 6 months
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 |
|---|---|---|
| PCV13 | Biological | PCV13 |
| PPV23 | Biological | PPV23 |
Primary outcome
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
Time frame: One month post-PCV13, PPV23
immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry)
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
Time frame: One month post-PCV13, PPV23
immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 29722823Farmaki PF, Chini MC, Mangafas NM, Tzanoudaki MT, Piperi CP, Lazanas MZ, Spoulou VS. Immunogenicity and Immunological Memory Induced by the 13-Valent Pneumococcal Conjugate Followed by the 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. J Infect Dis. 2018 Jun 5;218(1):26-34. doi: 10.1093/infdis/jiy135.
- Individual participant dataSharing planned: No
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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.
Vana Spoulou principal investigator
Greece 'Aghia Sophia' Children's Hospital Athens, Attiki, Greece, 11527
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCV13 and PPV23 in people with HIV Infection, run by Aghia Sophia Children's Hospital of Athens.
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 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 G (IgG) B memory cell response one month post vaccination (measured by flow cytometry) (time frame: One month post-PCV13, PPV23). 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 NCT03041051, which also lists 1 linked publication.
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 2 Feb 2017.