Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years
Background: This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo®; Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2–75 years, to provide data for licensure...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2015-09-01
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| Series: | International Journal of Infectious Diseases |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971215001708 |
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| author | Sanjay Lalwani Sharad Agarkhedkar Nithya Gogtay Sonali Palkar Shalaka Agarkhedkar Urmila Thatte Hoshang Vakil Rekha Jonnalagedda Paola Pedotti Margaret Hoyle Chiranjiwi Bhusal Ashwani Arora |
| author_facet | Sanjay Lalwani Sharad Agarkhedkar Nithya Gogtay Sonali Palkar Shalaka Agarkhedkar Urmila Thatte Hoshang Vakil Rekha Jonnalagedda Paola Pedotti Margaret Hoyle Chiranjiwi Bhusal Ashwani Arora |
| author_sort | Sanjay Lalwani |
| collection | DOAJ |
| description | Background: This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo®; Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2–75 years, to provide data for licensure in India.
Methods: A total of 180 subjects were enrolled (60 subjects 2–10 years, 60 subjects 11–18 years, and 60 subjects 19–75 years) and received one dose of MenACWY-CRM. Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination. Adverse events were collected throughout the 29-day study period.
Results: Percentages of subjects with post-vaccination hSBA ≥8 were 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively. Geometric mean titers rose 7-fold to 42-fold against the four serogroups. Similar immune responses were observed for the age subgroups 2–10 years, 11–18 years, and 19–75 years. Seroresponse rates at 1 month following vaccination were 72%, 88%, 55%, and 71% for serogroups A, C, W, and Y, respectively. The vaccine was well tolerated with no safety concerns.
Conclusion: A single dose of MenACWY-CRM induced a robust immune response against all four meningococcal serogroups and was well tolerated in an Indian population 2–75 years of age. |
| first_indexed | 2024-12-24T03:57:24Z |
| format | Article |
| id | doaj.art-e7357cfc23ef48bab6a6f72f15d4309b |
| institution | Directory Open Access Journal |
| issn | 1201-9712 1878-3511 |
| language | English |
| last_indexed | 2024-12-24T03:57:24Z |
| publishDate | 2015-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-e7357cfc23ef48bab6a6f72f15d4309b2022-12-21T17:16:25ZengElsevierInternational Journal of Infectious Diseases1201-97121878-35112015-09-0138C364210.1016/j.ijid.2015.07.003Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 yearsSanjay Lalwani0Sharad Agarkhedkar1Nithya Gogtay2Sonali Palkar3Shalaka Agarkhedkar4Urmila Thatte5Hoshang Vakil6Rekha Jonnalagedda7Paola Pedotti8Margaret Hoyle9Chiranjiwi Bhusal10Ashwani Arora11Bharati Vidyapeeth University Medical College and Hospital, Pune, IndiaPadmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, IndiaSeth GS Medical College and KEM Hospital, Mumbai, IndiaBharati Vidyapeeth University Medical College and Hospital, Pune, IndiaPadmasree Dr. D. Y. Patil Medical College, Hospital and Research Center, Pune, IndiaSeth GS Medical College and KEM Hospital, Mumbai, IndiaNovartis Healthcare Pvt. Ltd, Hyderabad, IndiaNovartis Healthcare Pvt. Ltd, Hyderabad, IndiaGlaxoSmithKline B.V., Amsterdam, The NetherlandsNovartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, ItalyNovartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, ItalyNovartis Vaccines and Diagnostics S.r.l. (a GSK company), Via Fiorentina, 1, I-53100 Siena, ItalyBackground: This phase 3, multi-center, open-label study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo®; Novartis Vaccines and Diagnostics S.r.l., Siena, Italy) in healthy Indian subjects aged 2–75 years, to provide data for licensure in India. Methods: A total of 180 subjects were enrolled (60 subjects 2–10 years, 60 subjects 11–18 years, and 60 subjects 19–75 years) and received one dose of MenACWY-CRM. Serum bactericidal activity with human complement (hSBA) was measured before and 1 month after vaccination. Adverse events were collected throughout the 29-day study period. Results: Percentages of subjects with post-vaccination hSBA ≥8 were 72%, 95%, 94%, and 90% for serogroups A, C, W, and Y, respectively. Geometric mean titers rose 7-fold to 42-fold against the four serogroups. Similar immune responses were observed for the age subgroups 2–10 years, 11–18 years, and 19–75 years. Seroresponse rates at 1 month following vaccination were 72%, 88%, 55%, and 71% for serogroups A, C, W, and Y, respectively. The vaccine was well tolerated with no safety concerns. Conclusion: A single dose of MenACWY-CRM induced a robust immune response against all four meningococcal serogroups and was well tolerated in an Indian population 2–75 years of age.http://www.sciencedirect.com/science/article/pii/S1201971215001708Meningococcal diseaseQuadrivalent vaccineCRM197 conjugateImmunogenicitySafetyIndia |
| spellingShingle | Sanjay Lalwani Sharad Agarkhedkar Nithya Gogtay Sonali Palkar Shalaka Agarkhedkar Urmila Thatte Hoshang Vakil Rekha Jonnalagedda Paola Pedotti Margaret Hoyle Chiranjiwi Bhusal Ashwani Arora Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years International Journal of Infectious Diseases Meningococcal disease Quadrivalent vaccine CRM197 conjugate Immunogenicity Safety India |
| title | Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years |
| title_full | Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years |
| title_fullStr | Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years |
| title_full_unstemmed | Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years |
| title_short | Safety and immunogenicity of an investigational meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy Indian subjects aged 2 to 75 years |
| title_sort | safety and immunogenicity of an investigational meningococcal acwy conjugate vaccine menacwy crm in healthy indian subjects aged 2 to 75 years |
| topic | Meningococcal disease Quadrivalent vaccine CRM197 conjugate Immunogenicity Safety India |
| url | http://www.sciencedirect.com/science/article/pii/S1201971215001708 |
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