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Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination.
AIDS. 2015 Jul 17; 29(11):1345-54.AIDS

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.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study

Language

eng

PubMed ID

25888646

Citation

Bhorat, As'ad E., et al. "Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in HIV-infected Individuals Naive to Pneumococcal Vaccination." AIDS (London, England), vol. 29, no. 11, 2015, pp. 1345-54.
Bhorat AE, Madhi SA, Laudat F, et al. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015;29(11):1345-54.
Bhorat, A. E., Madhi, S. A., Laudat, F., Sundaraiyer, V., Gurtman, A., Jansen, K. U., Scott, D. A., Emini, E. A., Gruber, W. C., & Schmoele-Thoma, B. (2015). Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS (London, England), 29(11), 1345-54. https://doi.org/10.1097/QAD.0000000000000689
Bhorat AE, et al. Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in HIV-infected Individuals Naive to Pneumococcal Vaccination. AIDS. 2015 Jul 17;29(11):1345-54. PubMed PMID: 25888646.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AU - Bhorat,As'ad E, AU - Madhi,Shabir A, AU - Laudat,France, AU - Sundaraiyer,Vani, AU - Gurtman,Alejandra, AU - Jansen,Kathrin U, AU - Scott,Daniel A, AU - Emini,Emilio A, AU - Gruber,William C, AU - Schmoele-Thoma,Beate, PY - 2015/4/19/entrez PY - 2015/4/19/pubmed PY - 2016/3/26/medline SP - 1345 EP - 54 JF - AIDS (London, England) JO - AIDS VL - 29 IS - 11 N2 - 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. SN - 1473-5571 UR - https://www.unboundmedicine.com/medline/citation/25888646/Immunogenicity_and_safety_of_the_13_valent_pneumococcal_conjugate_vaccine_in_HIV_infected_individuals_naive_to_pneumococcal_vaccination_ L2 - https://doi.org/10.1097/QAD.0000000000000689 DB - PRIME DP - Unbound Medicine ER -