Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial

Abstract Introduction Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to investigate the impact of concomitant administration of a quadrivalent HPV (HPV4)...

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Main Authors: Yan Miao, Thembile Mzolo, Michele Pellegrini
Format: Article
Language:English
Published: Adis, Springer Healthcare 2019-08-01
Series:Infectious Diseases and Therapy
Subjects:
Online Access:http://link.springer.com/article/10.1007/s40121-019-00258-5
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spelling doaj-638d48cbe057412d8368c14836e9256b2020-11-25T03:35:34ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822019-08-018333534110.1007/s40121-019-00258-5Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled TrialYan Miao0Thembile Mzolo1Michele Pellegrini2GSKGSKGSKAbstract Introduction Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to investigate the impact of concomitant administration of a quadrivalent HPV (HPV4) and Tdap vaccine with a quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM) in terms of immunogenicity against the different vaccine antigens and overall safety profile. Previous results showed that concomitant administration of the three vaccines did not impact the immunogenicity of Tdap and MenACWY, or safety. This article presents recently released HPV immunogenicity results. Methods Healthy adolescents aged 11–18 years (801) were randomized to receive either HPV4 + Tdap + MenACWY or HPV4 + Tdap + Placebo and two additional doses of HPV4 at 2 and 6 months after the first dose. Antibody responses to HPV types (HPV-6, -11, -16 and -18) were assessed at baseline and at 1 month post-full vaccination. Results Post-third HPV4 dose, non-inferiority of immune responses to HPV4 + Tdap + MenACWY vs. HPV4 + Tdap + Placebo was demonstrated; the lower limits of two-sided 95% CIs of the between-group differences in seroconversion rates were > − 5% (non-inferiority margin) against each HPV type tested. Seroconversion rates ranged between 98.0% (HPV-6) and 99.7% (HPV-11 and HPV-18) in group HPV4 + Tdap + MenACWY and from 99.0% (HPV-11 and HPV-16) to 99.7% (HPV-6 and HPV-18) in group HPV4 + Tdap + Placebo. Conclusion Overall, these data support the concomitant administration of HPV4, Tdap and MenACWY-CRM in adolescents. Funding Novartis Vaccines and Diagnostics Inc., now part of the GSK group of companies. Trial Registration ClinicalTrials.gov identifier, NCT01424644.http://link.springer.com/article/10.1007/s40121-019-00258-5AdolescentsCo-administrationHuman papillomavirus vaccineQuadrivalent meningococcal conjugate vaccineTetanus-diphtheria-acellular pertussis vaccine
collection DOAJ
language English
format Article
sources DOAJ
author Yan Miao
Thembile Mzolo
Michele Pellegrini
spellingShingle Yan Miao
Thembile Mzolo
Michele Pellegrini
Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
Infectious Diseases and Therapy
Adolescents
Co-administration
Human papillomavirus vaccine
Quadrivalent meningococcal conjugate vaccine
Tetanus-diphtheria-acellular pertussis vaccine
author_facet Yan Miao
Thembile Mzolo
Michele Pellegrini
author_sort Yan Miao
title Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
title_short Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
title_full Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
title_fullStr Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
title_full_unstemmed Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial
title_sort immunogenicity of a quadrivalent human papillomavirus vaccine when co-administered with tetanus-reduced diphtheria-acellular pertussis and quadrivalent meningococcal conjugate vaccines in healthy adolescents: results from a randomized, observer-blind, controlled trial
publisher Adis, Springer Healthcare
series Infectious Diseases and Therapy
issn 2193-8229
2193-6382
publishDate 2019-08-01
description Abstract Introduction Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to investigate the impact of concomitant administration of a quadrivalent HPV (HPV4) and Tdap vaccine with a quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM) in terms of immunogenicity against the different vaccine antigens and overall safety profile. Previous results showed that concomitant administration of the three vaccines did not impact the immunogenicity of Tdap and MenACWY, or safety. This article presents recently released HPV immunogenicity results. Methods Healthy adolescents aged 11–18 years (801) were randomized to receive either HPV4 + Tdap + MenACWY or HPV4 + Tdap + Placebo and two additional doses of HPV4 at 2 and 6 months after the first dose. Antibody responses to HPV types (HPV-6, -11, -16 and -18) were assessed at baseline and at 1 month post-full vaccination. Results Post-third HPV4 dose, non-inferiority of immune responses to HPV4 + Tdap + MenACWY vs. HPV4 + Tdap + Placebo was demonstrated; the lower limits of two-sided 95% CIs of the between-group differences in seroconversion rates were > − 5% (non-inferiority margin) against each HPV type tested. Seroconversion rates ranged between 98.0% (HPV-6) and 99.7% (HPV-11 and HPV-18) in group HPV4 + Tdap + MenACWY and from 99.0% (HPV-11 and HPV-16) to 99.7% (HPV-6 and HPV-18) in group HPV4 + Tdap + Placebo. Conclusion Overall, these data support the concomitant administration of HPV4, Tdap and MenACWY-CRM in adolescents. Funding Novartis Vaccines and Diagnostics Inc., now part of the GSK group of companies. Trial Registration ClinicalTrials.gov identifier, NCT01424644.
topic Adolescents
Co-administration
Human papillomavirus vaccine
Quadrivalent meningococcal conjugate vaccine
Tetanus-diphtheria-acellular pertussis vaccine
url http://link.springer.com/article/10.1007/s40121-019-00258-5
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AT thembilemzolo immunogenicityofaquadrivalenthumanpapillomavirusvaccinewhencoadministeredwithtetanusreduceddiphtheriaacellularpertussisandquadrivalentmeningococcalconjugatevaccinesinhealthyadolescentsresultsfromarandomizedobserverblindcontrolledtrial
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