Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials

Objectives: This study systematically reviewed the published literature from clinical trials on the efficacy and immunogenicity of single-dose HPV vaccination compared to multidose schedules or no HPV vaccination. Methods: Four databases were searched for relevant articles published from Jan-1999 to...

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Główni autorzy: Hilary S. Whitworth, Sandra Mounier-Jack, Edward M. Choi, Katherine E. Gallagher, Natasha Howard, Helen Kelly, Gladys Mbwanji, Aimée R Kreimer, Partha Basu, Ruanne Barnabas, Mélanie Drolet, Marc Brisson, Deborah Watson-Jones
Format: Artykuł
Język:English
Wydane: Elsevier 2024-08-01
Seria:Vaccine: X
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Dostęp online:http://www.sciencedirect.com/science/article/pii/S2590136224000597
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author Hilary S. Whitworth
Sandra Mounier-Jack
Edward M. Choi
Katherine E. Gallagher
Natasha Howard
Helen Kelly
Gladys Mbwanji
Aimée R Kreimer
Partha Basu
Ruanne Barnabas
Mélanie Drolet
Marc Brisson
Deborah Watson-Jones
author_facet Hilary S. Whitworth
Sandra Mounier-Jack
Edward M. Choi
Katherine E. Gallagher
Natasha Howard
Helen Kelly
Gladys Mbwanji
Aimée R Kreimer
Partha Basu
Ruanne Barnabas
Mélanie Drolet
Marc Brisson
Deborah Watson-Jones
author_sort Hilary S. Whitworth
collection DOAJ
description Objectives: This study systematically reviewed the published literature from clinical trials on the efficacy and immunogenicity of single-dose HPV vaccination compared to multidose schedules or no HPV vaccination. Methods: Four databases were searched for relevant articles published from Jan-1999 to Feb-2023. Articles were assessed for eligibility for inclusion using pre-defined criteria. Relevant data were extracted from eligible articles and a descriptive quality assessment was performed for each study. A narrative data synthesis was conducted, examining HPV infection, other clinical outcomes and immunogenicity responses by dose schedule. Results: Fifteen articles reporting data from six studies (all in healthy young females) were included. One article was included from each of three studies that prospectively randomised participants to receive a single HPV vaccine dose versus one or more comparator schedule(s). The other 12 articles reported data from three studies that randomised participants to receive multidose HPV vaccine (or control vaccine) schedules; in those studies, some participants failed to complete their allocated schedule, and evaluations were conducted to compare participants who actually received one, two or three doses. Across all efficacy studies, the incidence or prevalence of HPV16/18 infection was very low among HPV-vaccinated participants, regardless of the number of doses received; with no evidence for a difference between dose groups. In immunogenicity studies, HPV16/18 antibody seropositivity rates were high among all HPV-vaccinated participants. Antibody levels were significantly lower with one dose compared to two or three doses, but levels with one dose were stable and sustained to 11 years post-vaccination. Conclusions: Results from this review support recent World Health Organization recommendations allowing either one- or two-dose HPV vaccination in healthy young females. Longer-term efficacy and immunogenicity data from ongoing studies are awaited. Randomised trials of single-dose HPV-vaccination are urgently needed in other populations, e.g. boys, older females and people with HIV.
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spelling doaj.art-dbc0d68e8cbe435f8dcb8d94e522775e2024-08-14T04:52:08ZengElsevierVaccine: X2590-13622024-08-0119100486Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trialsHilary S. Whitworth0Sandra Mounier-Jack1Edward M. Choi2Katherine E. Gallagher3Natasha Howard4Helen Kelly5Gladys Mbwanji6Aimée R Kreimer7Partha Basu8Ruanne Barnabas9Mélanie Drolet10Marc Brisson11Deborah Watson-Jones12Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United KingdomFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United KingdomFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United KingdomFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United KingdomFaculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom; Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, SingaporeFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United KingdomMwanza Intervention Trials Unit, National Institute of Medical Research, Mwanza, TanzaniaNational Cancer Institute, National Institute of Health, Bethesda, MD, United StatesInternational Agency for Research on Cancer, World Health Organization, Lyon, FranceDivision of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, United StatesDepartment of Social and Preventive Medicine, Laval University, Québec, CanadaDepartment of Social and Preventive Medicine, Laval University, Québec, CanadaFaculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; Mwanza Intervention Trials Unit, National Institute of Medical Research, Mwanza, Tanzania; Corresponding author at: LSHTM, Keppel Street, London WC1E 7HT, United Kingdom.Objectives: This study systematically reviewed the published literature from clinical trials on the efficacy and immunogenicity of single-dose HPV vaccination compared to multidose schedules or no HPV vaccination. Methods: Four databases were searched for relevant articles published from Jan-1999 to Feb-2023. Articles were assessed for eligibility for inclusion using pre-defined criteria. Relevant data were extracted from eligible articles and a descriptive quality assessment was performed for each study. A narrative data synthesis was conducted, examining HPV infection, other clinical outcomes and immunogenicity responses by dose schedule. Results: Fifteen articles reporting data from six studies (all in healthy young females) were included. One article was included from each of three studies that prospectively randomised participants to receive a single HPV vaccine dose versus one or more comparator schedule(s). The other 12 articles reported data from three studies that randomised participants to receive multidose HPV vaccine (or control vaccine) schedules; in those studies, some participants failed to complete their allocated schedule, and evaluations were conducted to compare participants who actually received one, two or three doses. Across all efficacy studies, the incidence or prevalence of HPV16/18 infection was very low among HPV-vaccinated participants, regardless of the number of doses received; with no evidence for a difference between dose groups. In immunogenicity studies, HPV16/18 antibody seropositivity rates were high among all HPV-vaccinated participants. Antibody levels were significantly lower with one dose compared to two or three doses, but levels with one dose were stable and sustained to 11 years post-vaccination. Conclusions: Results from this review support recent World Health Organization recommendations allowing either one- or two-dose HPV vaccination in healthy young females. Longer-term efficacy and immunogenicity data from ongoing studies are awaited. Randomised trials of single-dose HPV-vaccination are urgently needed in other populations, e.g. boys, older females and people with HIV.http://www.sciencedirect.com/science/article/pii/S2590136224000597Human papillomavirusVaccineDosageEfficacyImmunogenicity
spellingShingle Hilary S. Whitworth
Sandra Mounier-Jack
Edward M. Choi
Katherine E. Gallagher
Natasha Howard
Helen Kelly
Gladys Mbwanji
Aimée R Kreimer
Partha Basu
Ruanne Barnabas
Mélanie Drolet
Marc Brisson
Deborah Watson-Jones
Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
Vaccine: X
Human papillomavirus
Vaccine
Dosage
Efficacy
Immunogenicity
title Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
title_full Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
title_fullStr Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
title_full_unstemmed Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
title_short Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination: An updated systematic review of evidence from clinical trials
title_sort efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to multidose vaccination regimens or no vaccination an updated systematic review of evidence from clinical trials
topic Human papillomavirus
Vaccine
Dosage
Efficacy
Immunogenicity
url http://www.sciencedirect.com/science/article/pii/S2590136224000597
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