title: Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.
abstract: OBJECTIVE
  Immunocompromised individuals are at an increased risk of pneumococcal disease. Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals. This study evaluated the safety and immunogenicity of three 13-valent pneumococcal conjugate vaccine (PCV13) doses followed by one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at 1-month intervals in pneumococcal vaccine-naive, HIV-infected individuals.
  
  
  METHODS
  This was a phase 3, open-label, single-arm study.
  
  
  METHODS
  Pneumococcal vaccine-naive, HIV-infected individuals at least 6 years of age with CD4 T-cell count at least 200  cells/μl and viral load less than 50 000  copies/ml received three doses of PCV13 followed by one dose of PPSV23 at 1-month intervals. Serotype-specific antipneumococcal immune responses were assessed by IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) assay geometric mean titres (GMTs) after each dose. Local reactions at the PCV13 injection site, systemic and other adverse events were collected.
  
  
  RESULTS
  Three hundred and one individuals were enrolled and vaccinated; 279 completed the study. Statistically significant increases in IgG GMCs and OPA GMTs were observed for all serotypes after dose 1 of PCV13 compared with prevaccine levels. GMCs and GMTs were comparable or only modestly increased for all serotypes after PCV13 doses 2 and 3 and after PPSV23. The majority of local reactions and systemic events were mild to moderate in severity.
  
  
  CONCLUSIONS
  A three-dose regimen of PCV13 was well tolerated in pneumococcal vaccine-naive, HIV-infected individuals. Significant immune responses to all serotypes were observed following the first dose of PCV13, with only modest increases in antibody titres following subsequent PCV13 or PPSV23 administration.
authors.affiliation: aSoweto Clinical Trials Centre bMedical Research Council: Respiratory and Meningeal Pathogens Research Unit & Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of Witwatersrand, Johannesburg, South Africa cPfizer Vaccine Research, Pearl River, New York dInVentiv Health Clinical, LLC, Princeton, New Jersey, USA ePfizer Pharma, GmbH, Berlin, Germany.
authors.forename: As'ad E
authors.initials: AE
authors.lastname: Bhorat
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.forename: France
authors.initials: F
authors.lastname: Laudat
authors.forename: Vani
authors.initials: V
authors.lastname: Sundaraiyer
authors.forename: Alejandra
authors.initials: A
authors.lastname: Gurtman
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.forename: Emilio A
authors.initials: EA
authors.lastname: Emini
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.forename: Beate
authors.initials: B
authors.lastname: Schmoele-Thoma
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D018791:CD4 Lymphocyte Count; D002648:Child; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D013296:Streptococcus pneumoniae / Q000276:immunology*; D019562:Viral Load
chemical_list: C538862:13-valent pneumococcal vaccine; C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines