- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02357823
Antibodies and Memory Cells Role After Different Pneumococcal Vaccines in HIV Adults
Long Term Serological Response and Memory Cells Role After Different Pneumococcal Vaccine Strategies in HIV Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be divided in 3 main aims; in the first, the long term immunological response to PCV13 and PPV23 in HIV+ adults will be evaluated. In a previous clinical trial (PRIN 2009 study, Clinicaltrials: NCT02123433) a cohort of HIV positive adults had been vaccinated either with 2 doses of PCV13 8 weeks apart or 1 dose of PPV23 (last enrollment: December 2012). Immunoglobulins G (IgGs) against 12 common pneumococcal serotypes included in PCV13 and PPV23 were quantified by ELISA at baseline (BL), 8, 24 and 48 weeks: analysis are still ongoing; preliminary data revealed that both vaccines were safe and well tolerated and showed similar immunogenicity. The present study aims to evaluate persistence of long term (>= 3 years) serological and memory B cells response in those previous vaccinated groups. In this phase, population will be screened for inclusion and exclusion criteria to entire study conduction. Once obtained informed consent, patients will be enrolled. Together with the collection of blood samples for routine purposes, an additional blood sample will be taken so to run immunological tests (ELISA, ELISpot). It is important to underline that no invasive procedures are needed for the study, apart from routine clinical practice: blood specimens will be obtained as part of routine investigations, blood will be hence taken for CD4+ cell count, viraemia analysis and anti-HIV drug monitoring; enrolled patients will agree just to donate a blood sample for research purposes. Blood samples will be collected from all previously PCV13 or PPV23 vaccinated HIV+ subjects and serum antibodies and B cells isotypes will be analyzed at baseline (BL), that is >= 3 years after a previous PCV13 or PPV23 vaccination.
The second objective of this study aims to evaluate short and long term immunological response with different combined vaccine strategies in HIV+ adults. Participants will be recruited if they'll have needed to receive antipneumococcal vaccines (primary or booster) according to clinical standard indications.
Elicited immunological response (serum antibodies and B cells isotypes) will be explored at BL, 8, 24, 48 and 96 weeks after additional different received pneumococcal vaccine strategies. At BL, after collecting blood samples as previously described for Aim1, every patient will be assigned to a specific Group on the basis of the received vaccine schedule, prescribed by clinicians according to individual clinical indications. Short- (30 minutes), medium- (<=5 days) and long-term adverse reactions will be reported, by clinical evaluation within 30 minute post-vaccine, phone call at day 5 and anamnestic data collection during follow up 8, 24, 48 and 96 weeks.
Blood samples will be analyzed at 8, 24, 48 and 96 weeks to evaluate serum antibodies and B cells isotypes.
Finally, the third aim of the study will lead an epidemiological and microbiological survey in vaccinated HIV+ adults. At BL, 8, 24, 48 and 96 weeks all clinical-anamnestic data will be updated, together with blood sample analysis to title IgG towards each vaccinal pneumococcal polysaccharides and to evaluate B cells isotypes and nasopharyngeal swab for S. pneumoniae culture, in vitro chemosusceptibility tests, serotyping, clonal analysis by Multilocus Locus Sequence Typing (MLST).
Carriage will be defined as S. pneumoniae isolation from one or more of the nasal swabs, in absence of any clinical signs or symptoms; a 12 months clinical follow up will be performed in colonized patients. All patients developing infections will be followed until resolution.
Study Type
Contacts and Locations
Study Locations
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Siena, Italy, 53100
- UOC Malattie Infettive Universitarie c/o Policlinico Le Scotte, Viale Mario Bracci 16
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Rome
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Roma, Rome, Italy, 00168
- Istituto di Clinica delle Malattie Infettive c/o Policlinico Gemelli, Largo Agostino Gemelli 12
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age between 18 and 65 years
- acceptance of informed consensus
- HIV positivity
- access to structures in ambulatory or Day Hospital regimen
- CD4+ cell count > or < than 200 cells/ul
- subjects for which Italian Ministry of Health recommend pneumococcal vaccination with PCV13 or PPV23
Exclusion Criteria:
- pregnancy
- acute infectious disease ongoing
- antibiotic therapy ongoing in the previous 7 days
- HIV-independent immunodepression
- chronic steroid therapy
- anatomic or functional asplenia
- contraindication to vaccination based on package insert drug facts, such as hypersensitivity to the active ingredient or one of the bulking agents (PPV23, Pneumovax);hypersensitivity to the active ingredient, to one of the bulking agents or to the diphteria toxoid (PCV13, Prevenar 13)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 2 PCV13 doses received from more than 3 years that have prescription for a single booster dose of PCV13.
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Study of short and long term immunological response after different schedule of PCV13 or PPV23
Evaluation of pneumococcal nasopharyngeal colonization
|
Group 2
Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years that have prescription to receive 2 doses (priming + boost) of PCV13.
|
Study of short and long term immunological response after different schedule of PCV13 or PPV23
Evaluation of pneumococcal nasopharyngeal colonization
|
Group 3
HIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count < 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23.
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Study of short and long term immunological response after different schedule of PCV13 or PPV23
Evaluation of pneumococcal nasopharyngeal colonization
|
Group 4
Immunological and microbiological status of HIV- positive adults that have never received a pneumococcal vaccine (naive) and have a CD4+ cell count > 200 cells/ul that have prescription to be primed with a single dose of PCV13 then boosted with a single dose of PPV23.
|
Study of short and long term immunological response after different schedule of PCV13 or PPV23
Evaluation of pneumococcal nasopharyngeal colonization
|
Group 5
Immunological and microbiological status of HIV- positive adults with pneumococcal vaccinal status of 1 PPV23 dose received from more than 3 years and that that have prescription to receive a single dose of PCV13.
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Study of short and long term immunological response after different schedule of PCV13 or PPV23
Evaluation of pneumococcal nasopharyngeal colonization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunological response evaluation
Time Frame: 24 months
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Dosing of serotype specific antibodies (cut off value: 0.35 mcg/mL for each vaccine polysaccharide antigen) and quantification of number and phenotype of serotype specific B cells
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Streptococcus pneumoniae colonization
Time Frame: 24 months
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Presence of S. pneumoniae in nasopharyngeal swabs culture
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24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Francesca Montagnani, MD, PhD, Università degli Studi di Siena - Dipartimento di Biotecnologie Mediche - Dipartimento di Malattie Infettive Universitarie
Publications and helpful links
General Publications
- Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. Erratum In: Clin Infect Dis. 2014 Jul 1;59(1):144.
- Clutterbuck EA, Lazarus R, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ. Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells. J Infect Dis. 2012 May 1;205(9):1408-16. doi: 10.1093/infdis/jis212. Epub 2012 Mar 29.
- Lu CL, Hung CC, Chuang YC, Liu WC, Su CT, Hsiao CF, Tseng YT, Su YC, Chang SF, Chang SY, Chang SC. Comparison of serologic responses to vaccination with one dose or two doses of 7-valent pneumococcal conjugate vaccine in HIV-infected adult patients. Vaccine. 2012 May 21;30(24):3526-33. doi: 10.1016/j.vaccine.2012.03.070. Epub 2012 Apr 4.
- Klugman KP, Madhi SA, Feldman C. HIV and pneumococcal disease. Curr Opin Infect Dis. 2007 Feb;20(1):11-5. doi: 10.1097/QCO.0b013e328012c5f1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCV13HIV-BOOST-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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