HIV InfectionPhase 3PCV13HIV2011NCT02123433
Serological Response to Antipneumococcal Vaccination and Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Adults
A Phase 3 study testing pneumococcal conjugate 13 valent vaccine in people with HIV Infection and Pneumococcal Infections, run by University of Siena at 2 sites in Italy.
Trial summary
S. pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection, Pneumococcal Infections
- What is being tested?
- pneumococcal conjugate 13 valent vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2011to Oct 2013
- Phase
- Phase 3
- 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
- > 18 years old
- obtained informed consent
- outpatient
- CD4 ≥200 cells/µl in the last two evaluations before T0
Who cannot join
- > 65 years old
- presence of acute infectious disease
- antibiotic therapy (ongoing or in the previous <= 7 days)
- previous PPV23 or PCV7 vaccination
- Pregnancy
- Current immunomodulatory therapy
- Immunosuppression not HIV related
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Istituto di Clinica delle Malattie Infettive, Policlinico Gemelli
Roma, 00168
UOC Malattie Infettive Universitarie, Policlinico Le Scotte
Siena, 53100
About this study
Official title: Serological Response to Antipneumococcal Vaccination and Consequent Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Positive Adults: a Prospective Study Using 13-valent Conjugate Vaccine
- pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain and their nasopharyngeal isolates have features similar to subsequent invasive strains. A 23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+ population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+ are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins results in an improved T-cell dependent immune response, characterized by increased antibody concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that are the main target of conjugate vaccines licensure. Some trials showed a better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23. However these data were not unequivocally confirmed in further studies on the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same or even better response compared to PPV23, with a safety and tolerability similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal infections. The purpose of this study is to evaluate serological response and prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following vaccination with 2 doses of PCV13.
- Conditions
- HIV Infection, Pneumococcal Infections
- Being tested
- pneumococcal conjugate 13 valent vaccine
- Keywords
- HIV, Streptococcus pneumoniae, 13-valent conjugate pneumococcal vaccine, Vaccine, Immunological Response, Pneumococcal Carriage
- Medical subject headings
- HIV Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal conjugate 13 valent vaccineBiological
Also called Prevenar13
Pneumococcal polysaccharide conjugate vaccine(13-valent adsorbed) conjugated to CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg of aluminum).
Pharmaceutical form: suspension for injection. Dosage: 0.5 ml, containing 2.2 g of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, and 4.4 micrograms for serotype 6B.
Prevenar 13 is administered in two doses,each of 0.5 ml, with an interval of 2 months, injected intramuscularly in the deltoid muscle of the arm.
| Study group | Role | What they receive |
|---|---|---|
| 13-valent vaccine | Experimental | Not described Receives: Biological: pneumococcal conjugate 13 valent vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological response after 2 doses of PCV13 vaccine.
Measure of serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults.
Measured: Twenty months
Pneumococcal nasopharyngeal colonization
to determine the rate of nasopharyngeal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0
Measured: Twenty months
Secondary outcomes (2)
Pneumococcal chemosusceptibility
Number and percentages of antibiotic resistant (including multiresistant) strains
Measured: Twenty months
Molecular epidemiology
Molecular typing combining PFGE (Pulsed Field Gel Electrophoresis), MLST (MultiLocus Sequence Typing) and PCR analysis of bacterial isolates.
Measured: Twenty months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Responsible party
- Principal investigator, Francesca Montagnani, University of Siena
- Investigators
- Francesca Montagnani, MD, PhD, Principal investigator, Università di Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123433
- Sponsor's protocol ID
- 2011-004518-40
- Other IDs
- 2011-004518-40
- Acronym
- PCV13HIV2011
- Status last verified
- Apr 2014
- First submitted
- 13 Dec 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
Publications
Belmonti S, Rossetti B, Modica S, Paglicci L, Borghetti A, Ciccullo A, Picarelli C, Cauda R, De Luca A, Montagnani F, Lombardi F. Long-Term Serological Response to 13-Valent Pneumococcal Conjugate Vaccine Versus 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. Infect Dis Ther. 2019 Sep;8(3):453-462. doi: 10.1007/s40121-019-0256-z. Epub 2019 Jul 30.
PubMed 31364010Lombardi F, Belmonti S, Fabbiani M, Morandi M, Rossetti B, Tordini G, Cauda R, De Luca A, Di Giambenedetto S, Montagnani F. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study. PLoS One. 2016 Jun 3;11(6):e0156523. doi: 10.1371/journal.pone.0156523. eCollection 2016.
PubMed 27258647Belmonti S, Lombardi F, Morandi M, Fabbiani M, Tordini G, Cauda R, De Luca A, Di Giambenedetto S, Montagnani F. Evaluation and Optimization of an ELISA Procedure to Quantify Antibodies Against Pneumococcal Polysaccharides Included in the 13-Valent Conjugate Vaccine. J Immunoassay Immunochem. 2016;37(2):189-200. doi: 10.1080/15321819.2015.1106949.
PubMed 26506438
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Response to Antipneumococcal Vaccination and Consequent Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Positive Adults: a Prospective Study Using 13-valent Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT02123433
- Acronym / sponsor ID
- PCV13HIV2011 / 2011-004518-40
- Conditions
- HIV Infection, Pneumococcal Infections
- Keywords
- HIV, Streptococcus pneumoniae, 13-valent conjugate pneumococcal vaccine, Vaccine, Immunological Response, Pneumococcal Carriage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Collaborators
- Ministry of Education, Universities and Research, Italy
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Apr 2014 (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.
- pneumoniae is frequently isolated from nasal swabs of healthy subjects, but it can also cause severe diseases (pneumonia, bacteraemia, meningitis and sepsis).HIV-infected subjects are more sensitive to invasive diseases and recurrent infection than the general population. Nasal carriage is the main pathogenetic feature for invasive disease: bacteraemia is more frequent in carriers, HIV+ patients are constantly colonized by the same pneumococcal strain and their nasopharyngeal isolates have features similar to subsequent invasive strains. A 23-valent polysaccharide vaccine (PPV23) has long been available and recommended in the HIV+ population as prophylaxis for invasive disease. Studies regarding efficacy of PPV23 in HIV+ are controversial and highlight that immune response induced by PPV23 in HIV+ is poor and an hyporesponsiveness to repeated polysaccaridic antigens stimulation can occur. Moreover, PPV23 seems not to affect pneumococcal carriage status and could lead to emergence of non-vaccine serotypes. The conjugation of pneumococcal capsular polysaccharides to carrier proteins results in an improved T-cell dependent immune response, characterized by increased antibody concentrations and induction of T and B memory cells, with a demonstrated higher efficacy in children. A heptavalent vaccine conjugated with diphtheria toxoid (PCV7) is approved in Europe since 2001 and is effective in reducing incidence of invasive disease by vaccine serotypes (4, 6B, 9V, 14, 18C, 19F, 23F), in both children and adults, due to effect of herd immunity. A PCV13 formulation has recently been developed, covering PCV7 serotypes plus 1, 3, 5, 6A, 7F and 19A. PCV13 revealed the same safety profile as PCV7 in pediatric patients, that are the main target of conjugate vaccines licensure. Some trials showed a better antibody response in terms of quantity and quality in HIV + adults by using PCV7 as compared to PPV23. However these data were not unequivocally confirmed in further studies on the use of PCV7 alone or in combination with PPV23. The first trials of PCV13 use in adults showed the same or even better response compared to PPV23, with a safety and tolerability similar to PCV7. PCV13 in HIV+ adults is a promising candidate prophylactic measure for pneumococcal infections. The purpose of this study is to evaluate serological response and prevalence of nasopharyngeal colonization by S. pneumoniae in HIV+ non-hospitalized adults, following vaccination with 2 doses of PCV13.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 13-valent vaccine | Experimental | Biological: pneumococcal conjugate 13 valent vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old
- obtained informed consent
- outpatient
- CD4 ≥200 cells/µl in the last two evaluations before T0
Key exclusion criteria (7 listed)
- > 65 years old
- presence of acute infectious disease
- antibiotic therapy (ongoing or in the previous <= 7 days)
- previous PPV23 or PCV7 vaccination
- Pregnancy
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 |
|---|---|---|
| pneumococcal conjugate 13 valent vaccineAlso: Prevenar13Pneumococcal polysaccharide conjugate vaccine(13-valent adsorbed) conjugated to CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg of aluminum). Pharmaceutical form: suspension for injection. Dosage: 0.5 ml, containing 2.2 g of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, and 4.4 micrograms for serotype 6B. Prevenar 13 is administered in two doses,each of 0.5 ml, with an interval of 2 months, injected intramuscularly in the deltoid muscle of the arm. | Biological | 13-valent vaccine |
Primary outcome
Serological response after 2 doses of PCV13 vaccine.
Time frame: Twenty months
Measure of serological response after 2 doses of PCV13 vaccine (booster dose after 8 weeks) in HIV+ adults.
Pneumococcal nasopharyngeal colonization
Time frame: Twenty months
to determine the rate of nasopharyngeal colonization by different pneumococcal serotypes in HIV-positive adults, in relation to baseline antibody titers at T0
2 secondary outcomes
Pneumococcal chemosusceptibility
Time frame: Twenty months
Molecular epidemiology
Time frame: Twenty 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 25 Apr 2014.
- Derived from this study: PubMed 31364010Belmonti S, Rossetti B, Modica S, Paglicci L, Borghetti A, Ciccullo A, Picarelli C, Cauda R, De Luca A, Montagnani F, Lombardi F. Long-Term Serological Response to 13-Valent Pneumococcal Conjugate Vaccine Versus 23-Valent Polysaccharide Vaccine in HIV-Infected Adults. Infect Dis Ther. 2019 Sep;8(3):453-462. doi: 10.1007/s40121-019-0256-z. Epub 2019 Jul 30.
- Derived from this study: PubMed 27258647Lombardi F, Belmonti S, Fabbiani M, Morandi M, Rossetti B, Tordini G, Cauda R, De Luca A, Di Giambenedetto S, Montagnani F. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study. PLoS One. 2016 Jun 3;11(6):e0156523. doi: 10.1371/journal.pone.0156523. eCollection 2016.
- Derived from this study: PubMed 26506438Belmonti S, Lombardi F, Morandi M, Fabbiani M, Tordini G, Cauda R, De Luca A, Di Giambenedetto S, Montagnani F. Evaluation and Optimization of an ELISA Procedure to Quantify Antibodies Against Pneumococcal Polysaccharides Included in the 13-Valent Conjugate Vaccine. J Immunoassay Immunochem. 2016;37(2):189-200. doi: 10.1080/15321819.2015.1106949.
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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.
Francesca Montagnani, MD, PhD principal investigator
Università di Siena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pneumococcal conjugate 13 valent vaccine in people with HIV Infection and Pneumococcal Infections, run by University of Siena at 2 sites in Italy.
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 4 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Serological response after 2 doses of PCV13 vaccine. (time frame: Twenty months). 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 NCT02123433, which also lists 3 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 25 Apr 2014.