Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial
Streptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) o...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2017-09-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2017.1331796 |
| _version_ | 1797677566955356160 |
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| author | Bhagirath B. Solanki Christine Juergens Manojkumar B. Chopada Pravin Supe Vani Sundaraiyer Natacha Le Dren-Narayanin Mark W. Cutler William C. Gruber Daniel A. Scott Beate Schmoele-Thoma |
| author_facet | Bhagirath B. Solanki Christine Juergens Manojkumar B. Chopada Pravin Supe Vani Sundaraiyer Natacha Le Dren-Narayanin Mark W. Cutler William C. Gruber Daniel A. Scott Beate Schmoele-Thoma |
| author_sort | Bhagirath B. Solanki |
| collection | DOAJ |
| description | Streptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) on natural exposure or revaccination has been shown to protect against community-acquired pneumonia and invasive pneumococcal disease in adults 65 years of age and older. An unconjugated 23-valent pneumococcal polysaccharide vaccine has been available for decades; however, data on protection against pneumonia are inconsistent. For the first time, a multicenter study has been conducted in India to assess the safety and immunogenicity of a single dose of PCV13 in adults aged 50 to 65 years. In this study, PCV13 elicited robust immune responses against all 13 pneumococcal serotypes as reflected by the magnitude of geometric mean fold rises (range, 6.6–102.7) in functional antibody levels from before to 1 month after vaccination. No serious adverse events occurred. These clinical trial findings support the safety and immunogenicity of PCV13 when administered to adults in India and indicate that a single dose of PCV13 has the potential to protect against vaccine-type pneumococcal disease in adults aged 50 to 65 years. ClinicalTrials.gov identifier: NCT02034877 |
| first_indexed | 2024-03-11T22:47:09Z |
| format | Article |
| id | doaj.art-afc33cd2bb744b43a87b5250a19ac0cc |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:47:09Z |
| publishDate | 2017-09-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-afc33cd2bb744b43a87b5250a19ac0cc2023-09-22T08:17:50ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2017-09-011392065207110.1080/21645515.2017.13317961331796Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trialBhagirath B. Solanki0Christine Juergens1Manojkumar B. Chopada2Pravin Supe3Vani Sundaraiyer4Natacha Le Dren-Narayanin5Mark W. Cutler6William C. Gruber7Daniel A. Scott8Beate Schmoele-Thoma9B. J. Medical College and Civil HospitalPfizer Pharma GmbHChopda Medicare and Research Centre Pvt. Ltd.Supe Heart and Diabetes Hospital and Research CentreinVentiv Health Clinical, LLCPfizer LtdPfizer IncPfizer IncPfizer IncPfizer Pharma GmbHStreptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) on natural exposure or revaccination has been shown to protect against community-acquired pneumonia and invasive pneumococcal disease in adults 65 years of age and older. An unconjugated 23-valent pneumococcal polysaccharide vaccine has been available for decades; however, data on protection against pneumonia are inconsistent. For the first time, a multicenter study has been conducted in India to assess the safety and immunogenicity of a single dose of PCV13 in adults aged 50 to 65 years. In this study, PCV13 elicited robust immune responses against all 13 pneumococcal serotypes as reflected by the magnitude of geometric mean fold rises (range, 6.6–102.7) in functional antibody levels from before to 1 month after vaccination. No serious adverse events occurred. These clinical trial findings support the safety and immunogenicity of PCV13 when administered to adults in India and indicate that a single dose of PCV13 has the potential to protect against vaccine-type pneumococcal disease in adults aged 50 to 65 years. ClinicalTrials.gov identifier: NCT02034877http://dx.doi.org/10.1080/21645515.2017.1331796adultsindiaimmunogenicitysafetythirteen-valent pneumococcal conjugate vaccine |
| spellingShingle | Bhagirath B. Solanki Christine Juergens Manojkumar B. Chopada Pravin Supe Vani Sundaraiyer Natacha Le Dren-Narayanin Mark W. Cutler William C. Gruber Daniel A. Scott Beate Schmoele-Thoma Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial Human Vaccines & Immunotherapeutics adults india immunogenicity safety thirteen-valent pneumococcal conjugate vaccine |
| title | Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial |
| title_full | Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial |
| title_fullStr | Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial |
| title_full_unstemmed | Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial |
| title_short | Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An open-label trial |
| title_sort | safety and immunogenicity of a 13 valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in india an open label trial |
| topic | adults india immunogenicity safety thirteen-valent pneumococcal conjugate vaccine |
| url | http://dx.doi.org/10.1080/21645515.2017.1331796 |
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