Clinical Trials

MainTitle

Serological Response to Antipneumococcal Vaccination and Impact on Streptococcus Pneumoniae Nasal Carriage in HIV Adults (PCV13HIV2011)

This study has been completed
Sponsor
University of Siena

Collaborator
Ministry of Education, Universities and Research, Italy

Information provided by (Responsible Party)
Francesca Montagnani, University of Siena

ClinicalTrials.gov Identifier
NCT02123433

First received: December 13, 2013
Last updated: April 23, 2014
Last Verified: April 2014
History of Changes
Purpose

Purpose

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. 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.

Condition Intervention Phase
HIV Infection
Pneumococcal Infections

Biological : pneumococcal conjugate 13 valent vaccine
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by Francesca Montagnani, University of Siena:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • Pneumococcal chemosusceptibility [ Time Frame: Twenty months ]
    Number and percentages of antibiotic resistant (including multiresistant) strains
  • Molecular epidemiology [ Time Frame: Twenty months ]
    Molecular typing combining PFGE (Pulsed Field Gel Electrophoresis), MLST (MultiLocus Sequence Typing) and PCR analysis of bacterial isolates.

Enrollment: 50
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 13-valent vaccine

Biological: pneumococcal conjugate 13 valent vaccine
  • 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.

Other Name: Prevenar13
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • > 18 years old
  • obtained informed consent
  • outpatient
  • CD4 ≥200 cells/µl in the last two evaluations before T0


Exclusion Criteria:
  • > 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02123433

Locations

Italy
Istituto di Clinica delle Malattie Infettive, Policlinico Gemelli
Roma, Italy, 00168
UOC Malattie Infettive Universitarie, Policlinico Le Scotte
Siena, Italy, 53100

Sponsors and Collaborators

University of Siena
Ministry of Education, Universities and Research, Italy

Investigators

Principal Investigator: Francesca Montagnani, MD, PhD Università di Siena
More Information

More Information


Responsible Party: Francesca Montagnani, Assistant Professor, University of Siena  
ClinicalTrials.gov Identifier: NCT02123433   History of Changes  
Other Study ID Numbers: 2011-004518-40  
  2011-004518-40  
Study First Received: December 13, 2013  
Last Updated: April 23, 2014  

Keywords provided by Francesca Montagnani, University of Siena:

HIV
Streptococcus pneumoniae
13-valent conjugate pneumococcal vaccine
Vaccine
Immunological Response
Pneumococcal Carriage

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Pneumonia
Pneumococcal Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine

ClinicalTrials.gov processed this data on November 22, 2017
This information is provided by ClinicalTrials.gov.