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Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.

Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B - AIDS (2015)

Bottom Line: Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals.Statistically significant increases in IgG GMCs and OPA GMTs were observed for all serotypes after dose 1 of PCV13 compared with prevaccine levels.A three-dose regimen of PCV13 was well tolerated in pneumococcal vaccine-naive, HIV-infected individuals.

View Article: PubMed Central - PubMed

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.

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.

Design: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus

Antipneumococcal responses after PCV13 vaccination.
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Related In: Results  -  Collection


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Figure 1: Antipneumococcal responses after PCV13 vaccination.

Mentions: There was an increase in IgG GMCs for all serotypes after dose 1 of PCV13 in the overall population with statistically significant increases in GMCs observed for all serotypes after dose 1 compared with before dose 1 (Table 2 and Fig. 1a). IgG GMCs were similar or increased for all serotypes after doses 2 and 3 of PCV13 compared with the previous doses and after the single dose of PPSV23 compared with PCV13 dose 3; however, increases were modest in contrast to those occurring from before to after dose 1 of PCV13. Statistically significant increases in IgG GMCs were observed for six of the 13 serotypes after dose 3 compared with after dose 2. In addition, IgG GMCs were only modestly increased after dose 3 compared with after dose 1 (see Table, Supplemental Digital Content 2). Generally, results for the 6- to 17-year and the at least 18-year age groups were numerically similar to each other and to the overall evaluable immunogenicity population (see Table, Supplemental Digital Content 3). In both age groups, statistically significant increases in IgG GMCs were observed for all serotypes after dose 1 compared with before dose 1. IgG GMCs were comparable or modestly increased in both age groups for most serotypes after doses 2 and 3 of PCV13 compared with after the previous dose and after the single dose of PPSV23 compared with after PCV13 dose 3. Statistically significant increases in IgG GMCs were observed in five and three of the 13 serotypes in the 6 to 17-years and at least 18-years age groups, respectively, after dose 3 compared with after dose 2. A posthoc analysis of IgG GMCs according to sex found similar immune responses to those that occurred in the overall population (data not shown).


Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.

Bhorat AE, Madhi SA, Laudat F, Sundaraiyer V, Gurtman A, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B - AIDS (2015)

Antipneumococcal responses after PCV13 vaccination.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4521829&req=5

Figure 1: Antipneumococcal responses after PCV13 vaccination.
Mentions: There was an increase in IgG GMCs for all serotypes after dose 1 of PCV13 in the overall population with statistically significant increases in GMCs observed for all serotypes after dose 1 compared with before dose 1 (Table 2 and Fig. 1a). IgG GMCs were similar or increased for all serotypes after doses 2 and 3 of PCV13 compared with the previous doses and after the single dose of PPSV23 compared with PCV13 dose 3; however, increases were modest in contrast to those occurring from before to after dose 1 of PCV13. Statistically significant increases in IgG GMCs were observed for six of the 13 serotypes after dose 3 compared with after dose 2. In addition, IgG GMCs were only modestly increased after dose 3 compared with after dose 1 (see Table, Supplemental Digital Content 2). Generally, results for the 6- to 17-year and the at least 18-year age groups were numerically similar to each other and to the overall evaluable immunogenicity population (see Table, Supplemental Digital Content 3). In both age groups, statistically significant increases in IgG GMCs were observed for all serotypes after dose 1 compared with before dose 1. IgG GMCs were comparable or modestly increased in both age groups for most serotypes after doses 2 and 3 of PCV13 compared with after the previous dose and after the single dose of PPSV23 compared with after PCV13 dose 3. Statistically significant increases in IgG GMCs were observed in five and three of the 13 serotypes in the 6 to 17-years and at least 18-years age groups, respectively, after dose 3 compared with after dose 2. A posthoc analysis of IgG GMCs according to sex found similar immune responses to those that occurred in the overall population (data not shown).

Bottom Line: Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals.Statistically significant increases in IgG GMCs and OPA GMTs were observed for all serotypes after dose 1 of PCV13 compared with prevaccine levels.A three-dose regimen of PCV13 was well tolerated in pneumococcal vaccine-naive, HIV-infected individuals.

View Article: PubMed Central - PubMed

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.

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.

Design: 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.

Conclusion: 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.

No MeSH data available.


Related in: MedlinePlus