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Burden of Disease
Burden of Disease
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Secondary Infections
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Prevention of Pneumococcal Disease
Need for Pneumococcal Vaccination
Cost-effectiveness of PCV13
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Prevenar 13® Clinical Experience
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Effectiveness of Prevenar 13®
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PCV13 in HIV Infection
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Immunogenicity and Safety Data of PCV13 in HIV-infected Adults
A randomised clinical trial was performed to compare the immunologic response towards a combined immunisation strategy involving the use of PCV13 with PPSV23 (prime-boost vaccine group), as compared with PPSV23 alone, in HIV-infected adults. The prime-boost vaccine group achieved a ≥4-fold increase in GMT at Week 8 and a ≥2-fold increase in IgG GMC at 8 weeks. This study revealed that combining PCV13 with PPSV23 results in a higher magnitude of immune response in HIV-infected individuals at 8 weeks as compared with PPSV23 alone.1
A study investigated the immunogenicity induced by combined PCV13 and PPSV23 vaccines in HIV-infected adults. It was observed that the use of PPSV23 12 months after PCV13 improves PCV13 immunogenicity and PPSV23 has a decreasing effect on PCV13-associated immunological memory. These findings are in line with different guidelines that recommend the use of PCV13, instead of PPSV23 in HIV-positive individuals.2
In an open-label study, 329 HIV-infected adults previously vaccinated with PPSV23 were assessed for safety and immune response to 3 doses of PCV13. PCV13 appeared well-tolerated and immunogenic in HIV-infected adults with CD4 counts ≥200 cells/mm.3,4 A Phase 3, open-label, single-arm study evaluated the immunogenicity and safety of 3 PCV13 doses followed by 1 dose of PPSV23 at 1 month in vaccine-naive individuals. Among 301 individuals enrolled and vaccinated, 279 individuals completed the study. The study revealed that the PCV13 regimen elicited significant immune responses to all serotypes and was well-tolerated in these HIV-infected individuals. However, subsequent PPSV23 or PCV13 administration resulted in only modest increases in the antibody titres.5
A randomised clinical trial conducted in Brazil with 331 HIV-infected patients evaluated the safety and efficacy of PCVs in these patients, alone and combined. In this study, both PCV7 and PPSV23 were found to be immunogenic and well-tolerated in these patients, and the immunogenicity of PCV7 was higher than PPSV23. No benefits were observed in combining the 2 vaccines.6
Song et al compared the immunogenicity of PCV13 in HIV-infected patients with CD4 T-cell count <350 cells/μL, as compared with those with a higher CD4 T-cell count. Although PCV13 was well- tolerated in all HIV-infected patients irrespective of their immune status, it showed significantly lower immunogenicity among patients with CD4 T-cell count <350 cells/μL, as compared with those HIV-infected patients with a higher CD4 T-cell count. The findings of this study indicate that it would be important to assess the optimum timing of vaccination in HIV-infected patients for achieving sufficiently protective immunity. However, current guidelines recommend PCV13 use in HIV-infected patients irrespective of CD4 T-cell count.7
Another recent study explored the virological and immunological outcomes of HIV-1–positive patients after immunisation with PCV13. In this retrospective study conducted in individuals aged ≥50 years, it was observed that in first 6 months after PCV13 vaccination amongst patients on stable virological suppression, confirmed virological failures and viral blips were rarely found. These findings indicated that the PCV13 is well tolerated in HIV-1–positive patients with respect to immunological and virological outcomes.8
A prospective pilot study compared the long-term immunological response with PCV13 versus PPSV23 among HIV-infected adults. It was observed that both vaccines achieved a serologic response that was durable over the long term. However, after 5 years of vaccination, minor differences were observed between the immunogenicity of the 2 vaccines, whereby PCV13 was found to be better than PPSV23.9
A study assessed the antibody responses of PCV13 and/or PPSV23 in elderly HIV-infected adults, aged between 50 and 65 years. As compared with the recommended regimen of PCV13/PPSV23, PPSV23 alone demonstrated a clear immunological advantage in older HIV-infected individuals, and as compared with HIV-PCV13/PPSV23 controls, antibody responses to PCV13/PPSV23 were lower.10 A previous study by the group had reported that upon revaccination with PPSV23 in this group of older adults, PCV13 does not enhance cellular responses.11
HIV, human immunodeficiency virus; CD4, cluster of differentiation 4; GMC, geometric mean concentration;
GMT, geometric mean titre; PCV7, 7-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine.
References:
Sadlier C, O’Dea S, Bennett K, et al. Immunological efficacy of pneumococcal vaccine strategies in HIV-infected adults: a randomized clinical trial. Sci Rep. 2016;6:32076.
Farmaki PF, Chini MC, Mangafas NM, et al. Immunogenicity and immunological memory induced by the 13-valent pneumococcal conjugate followed by the 23-valent polysaccharide vaccine in HIV-infected adults. J Infect Dis. 2018;218(1):26-34.
Glesby MJ, Brinson CC, Greenberg RN, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-positive adults with prior 23-valent pneumococcal polysaccharide vaccination. Presented at: 20th conference on retroviruses and opportunistic infections (CROI); March 3-6, 2013; Atlanta, GA, USA.
CDC. Pneumococcal disease. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-preventable Diseases. 13th ed. CDC; 2015. Accessed May 17, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/front-matter.html
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):1345-1354.
Ho YL, Brandão AP, de Cunto Brandileone MC, et al. Immunogenicity and safety of pneumococcal conjugate polysaccharide and free polysaccharide vaccines alone or combined in HIV-infected adults in Brazil. Vaccine. 2013;31(37):4047-4053.
Song JY, Cheong HJ, Noh JY, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults in the era of highly active antiretroviral therapy: analysis stratified by CD4 T-cell count. Hum Vaccin Immunother. 2020;16(1):169-175.
Dell’Acqua R, Galli L, Poli A, et al. Viro-immunological outcomes after 13-valent pneumococcal vaccination in HIV-1-infected individuals on stable virological suppression. AIDS. 2019;33(13):1987-1994.
Belmonti S, Rossetti B, Modica S, et al. Long-term serological response to 13-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in HIV-infected adults. Infect Dis Ther. 2019;8(3):453-462.
Ohtola JA, Saul-McBeth JL, Iyer AS, et al. Quantitative and functional antibody responses to the 13-valent conjugate and/or 23-valent purified polysaccharide vaccine in aging HIV-infected adults. J AIDS Clin Res. 2016;7(3):556.
Ohtola JA, Khaskhely NM, Saul-Mcbeth JL, et al. Alterations in serotype-specific B cell responses to the 13-valent pneumococcal conjugate vaccine in aging HIV-infected adults. Vaccine. 2016;34(4):451-457.
Please click the Prescribing Information link to view the safety and adverse events information of Prevenar 13®.
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PP-PRV-IND-0268 July 2022
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