Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials
•We reviewed the efficacy and immunogenicity of 1 vs. 0, 2 or 3 HPV vaccine doses in clinical trials.•HPV16/18 infection was rare in all HPV vaccine recipients, regardless of number of doses received (3, 2 or 1).•Frequency of infection was significantly lower in 1-dose recipients than in unvaccinate...
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| Veröffentlicht in: | Vaccine 2020-02, Vol.38 (6), p.1302-1314 |
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| creator | Whitworth, Hilary S. Gallagher, Katherine E. Howard, Natasha Mounier-Jack, Sandra Mbwanji, Gladys Kreimer, Aimée R. Basu, Partha Kelly, Helen Drolet, Mélanie Brisson, Marc Watson-Jones, Deborah |
| description | •We reviewed the efficacy and immunogenicity of 1 vs. 0, 2 or 3 HPV vaccine doses in clinical trials.•HPV16/18 infection was rare in all HPV vaccine recipients, regardless of number of doses received (3, 2 or 1).•Frequency of infection was significantly lower in 1-dose recipients than in unvaccinated controls.•Most vaccine recipients produced HPV16/18 antibodies, but titres were lower with 1 dose compared to 2 or 3 doses.•1-dose results are promising, and ongoing purpose-designed, prospectively randomised trials will provide further evidence.
This study aimed to systematically review the literature on the efficacy and immunogenicity of single-dose HPV vaccination compared to no vaccination or multi-dose schedules among vaccine trial participants.
Medline, EMBASE, Global Health Database and Cochrane Central Register of Controlled Trials were searched for publications and conference abstracts (dated January 1999-August 2018) using MeSH and non-MeSH terms for human papillomavirus AND vaccines AND (immunogenicity OR efficacy/effectiveness) AND dosage. Search results were screened against pre-specified eligibility criteria. Data were extracted from included articles, and a narrative synthesis conducted on efficacy against HPV16/18 infection and humoral immunogenicity.
Seven of 6,523 unique records identified were included in the review. Six were nested observational studies of participants randomised to receive two or three doses in three large HPV vaccine trials, in which some participants did not complete their allocated schedules. One small pilot study prospectively allocated participants to receive one or no vaccine dose. Frequency of HPV16/18 infection was low (e.g. 0.05 in all cases). Frequency of infection was significantly lower in one-dose recipients compared to unvaccinated controls (p |
| doi_str_mv | 10.1016/j.vaccine.2019.12.017 |
| format | Article |
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This study aimed to systematically review the literature on the efficacy and immunogenicity of single-dose HPV vaccination compared to no vaccination or multi-dose schedules among vaccine trial participants.
Medline, EMBASE, Global Health Database and Cochrane Central Register of Controlled Trials were searched for publications and conference abstracts (dated January 1999-August 2018) using MeSH and non-MeSH terms for human papillomavirus AND vaccines AND (immunogenicity OR efficacy/effectiveness) AND dosage. Search results were screened against pre-specified eligibility criteria. Data were extracted from included articles, and a narrative synthesis conducted on efficacy against HPV16/18 infection and humoral immunogenicity.
Seven of 6,523 unique records identified were included in the review. Six were nested observational studies of participants randomised to receive two or three doses in three large HPV vaccine trials, in which some participants did not complete their allocated schedules. One small pilot study prospectively allocated participants to receive one or no vaccine dose. Frequency of HPV16/18 infection was low (e.g. <1% for 12-month-persistent infection) in all vaccinated participants up to seven years post vaccination and did not significantly differ by number of doses (p > 0.05 in all cases). Frequency of infection was significantly lower in one-dose recipients compared to unvaccinated controls (p < 0.01 for all infection endpoints in each study). HPV16/18 seropositivity rates were high in all HPV vaccine recipients (100% in three of four studies reporting this endpoint), though antibody levels were lower with one compared to two or three doses.
This review supports the premise that one HPV vaccine dose may be as effective in preventing HPV infection as multi-dose schedules in healthy young women. However, it also highlights the paucity of available evidence from purpose-designed, prospectively-randomised trials. Results from ongoing clinical trials assessing the efficacy and immunogenicity of single-dose HPV vaccination compared to currently-recommended schedules are awaited.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2019.12.017</identifier><identifier>PMID: 31870572</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Antibodies ; Bias ; Clinical trials ; Dosage ; Efficacy ; Female ; Global health ; Human papillomavirus ; Human papillomavirus 16 - immunology ; Human papillomavirus 18 - immunology ; Humans ; Immunity, Humoral ; Immunization ; Immunization Schedule ; Immunogenicity ; Immunogenicity, Vaccine ; Literature reviews ; Observational studies ; Observational Studies as Topic ; Papillomavirus Infections - prevention & control ; Papillomavirus Vaccines - administration & dosage ; Papillomavirus Vaccines - immunology ; Randomization ; Randomized Controlled Trials as Topic ; Schedules ; Studies ; Systematic review ; Vaccination - methods ; Vaccine ; Vaccines ; Womens health</subject><ispartof>Vaccine, 2020-02, Vol.38 (6), p.1302-1314</ispartof><rights>2019</rights><rights>Copyright © 2019. Published by Elsevier Ltd.</rights><rights>Copyright Elsevier Limited Feb 5, 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-19d2529a5be38944b1e1809c3c04af1572fd195a17fecd1f796c465f6c0671d3</citedby><cites>FETCH-LOGICAL-c440t-19d2529a5be38944b1e1809c3c04af1572fd195a17fecd1f796c465f6c0671d3</cites><orcidid>0000-0003-4174-7349 ; 0000-0003-2353-2352 ; 0000-0002-5604-7647 ; 0000-0002-6073-2591 ; 0000-0002-2801-379X ; 0000-0003-0124-4050</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X19316597$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31870572$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Whitworth, Hilary S.</creatorcontrib><creatorcontrib>Gallagher, Katherine E.</creatorcontrib><creatorcontrib>Howard, Natasha</creatorcontrib><creatorcontrib>Mounier-Jack, Sandra</creatorcontrib><creatorcontrib>Mbwanji, Gladys</creatorcontrib><creatorcontrib>Kreimer, Aimée R.</creatorcontrib><creatorcontrib>Basu, Partha</creatorcontrib><creatorcontrib>Kelly, Helen</creatorcontrib><creatorcontrib>Drolet, Mélanie</creatorcontrib><creatorcontrib>Brisson, Marc</creatorcontrib><creatorcontrib>Watson-Jones, Deborah</creatorcontrib><title>Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>•We reviewed the efficacy and immunogenicity of 1 vs. 0, 2 or 3 HPV vaccine doses in clinical trials.•HPV16/18 infection was rare in all HPV vaccine recipients, regardless of number of doses received (3, 2 or 1).•Frequency of infection was significantly lower in 1-dose recipients than in unvaccinated controls.•Most vaccine recipients produced HPV16/18 antibodies, but titres were lower with 1 dose compared to 2 or 3 doses.•1-dose results are promising, and ongoing purpose-designed, prospectively randomised trials will provide further evidence.
This study aimed to systematically review the literature on the efficacy and immunogenicity of single-dose HPV vaccination compared to no vaccination or multi-dose schedules among vaccine trial participants.
Medline, EMBASE, Global Health Database and Cochrane Central Register of Controlled Trials were searched for publications and conference abstracts (dated January 1999-August 2018) using MeSH and non-MeSH terms for human papillomavirus AND vaccines AND (immunogenicity OR efficacy/effectiveness) AND dosage. Search results were screened against pre-specified eligibility criteria. Data were extracted from included articles, and a narrative synthesis conducted on efficacy against HPV16/18 infection and humoral immunogenicity.
Seven of 6,523 unique records identified were included in the review. Six were nested observational studies of participants randomised to receive two or three doses in three large HPV vaccine trials, in which some participants did not complete their allocated schedules. One small pilot study prospectively allocated participants to receive one or no vaccine dose. Frequency of HPV16/18 infection was low (e.g. <1% for 12-month-persistent infection) in all vaccinated participants up to seven years post vaccination and did not significantly differ by number of doses (p > 0.05 in all cases). Frequency of infection was significantly lower in one-dose recipients compared to unvaccinated controls (p < 0.01 for all infection endpoints in each study). HPV16/18 seropositivity rates were high in all HPV vaccine recipients (100% in three of four studies reporting this endpoint), though antibody levels were lower with one compared to two or three doses.
This review supports the premise that one HPV vaccine dose may be as effective in preventing HPV infection as multi-dose schedules in healthy young women. However, it also highlights the paucity of available evidence from purpose-designed, prospectively-randomised trials. 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immunology</topic><topic>Human papillomavirus 18 - immunology</topic><topic>Humans</topic><topic>Immunity, Humoral</topic><topic>Immunization</topic><topic>Immunization Schedule</topic><topic>Immunogenicity</topic><topic>Immunogenicity, Vaccine</topic><topic>Literature reviews</topic><topic>Observational studies</topic><topic>Observational Studies as Topic</topic><topic>Papillomavirus Infections - prevention & control</topic><topic>Papillomavirus Vaccines - administration & dosage</topic><topic>Papillomavirus Vaccines - immunology</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Schedules</topic><topic>Studies</topic><topic>Systematic review</topic><topic>Vaccination - methods</topic><topic>Vaccine</topic><topic>Vaccines</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Whitworth, Hilary S.</creatorcontrib><creatorcontrib>Gallagher, Katherine E.</creatorcontrib><creatorcontrib>Howard, Natasha</creatorcontrib><creatorcontrib>Mounier-Jack, Sandra</creatorcontrib><creatorcontrib>Mbwanji, Gladys</creatorcontrib><creatorcontrib>Kreimer, Aimée R.</creatorcontrib><creatorcontrib>Basu, Partha</creatorcontrib><creatorcontrib>Kelly, Helen</creatorcontrib><creatorcontrib>Drolet, Mélanie</creatorcontrib><creatorcontrib>Brisson, Marc</creatorcontrib><creatorcontrib>Watson-Jones, Deborah</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Whitworth, Hilary S.</au><au>Gallagher, Katherine E.</au><au>Howard, Natasha</au><au>Mounier-Jack, Sandra</au><au>Mbwanji, Gladys</au><au>Kreimer, Aimée R.</au><au>Basu, Partha</au><au>Kelly, Helen</au><au>Drolet, Mélanie</au><au>Brisson, Marc</au><au>Watson-Jones, Deborah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2020-02-05</date><risdate>2020</risdate><volume>38</volume><issue>6</issue><spage>1302</spage><epage>1314</epage><pages>1302-1314</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>•We reviewed the efficacy and immunogenicity of 1 vs. 0, 2 or 3 HPV vaccine doses in clinical trials.•HPV16/18 infection was rare in all HPV vaccine recipients, regardless of number of doses received (3, 2 or 1).•Frequency of infection was significantly lower in 1-dose recipients than in unvaccinated controls.•Most vaccine recipients produced HPV16/18 antibodies, but titres were lower with 1 dose compared to 2 or 3 doses.•1-dose results are promising, and ongoing purpose-designed, prospectively randomised trials will provide further evidence.
This study aimed to systematically review the literature on the efficacy and immunogenicity of single-dose HPV vaccination compared to no vaccination or multi-dose schedules among vaccine trial participants.
Medline, EMBASE, Global Health Database and Cochrane Central Register of Controlled Trials were searched for publications and conference abstracts (dated January 1999-August 2018) using MeSH and non-MeSH terms for human papillomavirus AND vaccines AND (immunogenicity OR efficacy/effectiveness) AND dosage. Search results were screened against pre-specified eligibility criteria. Data were extracted from included articles, and a narrative synthesis conducted on efficacy against HPV16/18 infection and humoral immunogenicity.
Seven of 6,523 unique records identified were included in the review. Six were nested observational studies of participants randomised to receive two or three doses in three large HPV vaccine trials, in which some participants did not complete their allocated schedules. One small pilot study prospectively allocated participants to receive one or no vaccine dose. Frequency of HPV16/18 infection was low (e.g. <1% for 12-month-persistent infection) in all vaccinated participants up to seven years post vaccination and did not significantly differ by number of doses (p > 0.05 in all cases). Frequency of infection was significantly lower in one-dose recipients compared to unvaccinated controls (p < 0.01 for all infection endpoints in each study). HPV16/18 seropositivity rates were high in all HPV vaccine recipients (100% in three of four studies reporting this endpoint), though antibody levels were lower with one compared to two or three doses.
This review supports the premise that one HPV vaccine dose may be as effective in preventing HPV infection as multi-dose schedules in healthy young women. However, it also highlights the paucity of available evidence from purpose-designed, prospectively-randomised trials. Results from ongoing clinical trials assessing the efficacy and immunogenicity of single-dose HPV vaccination compared to currently-recommended schedules are awaited.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>31870572</pmid><doi>10.1016/j.vaccine.2019.12.017</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0003-4174-7349</orcidid><orcidid>https://orcid.org/0000-0003-2353-2352</orcidid><orcidid>https://orcid.org/0000-0002-5604-7647</orcidid><orcidid>https://orcid.org/0000-0002-6073-2591</orcidid><orcidid>https://orcid.org/0000-0002-2801-379X</orcidid><orcidid>https://orcid.org/0000-0003-0124-4050</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2020-02, Vol.38 (6), p.1302-1314 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2330328410 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Antibodies Bias Clinical trials Dosage Efficacy Female Global health Human papillomavirus Human papillomavirus 16 - immunology Human papillomavirus 18 - immunology Humans Immunity, Humoral Immunization Immunization Schedule Immunogenicity Immunogenicity, Vaccine Literature reviews Observational studies Observational Studies as Topic Papillomavirus Infections - prevention & control Papillomavirus Vaccines - administration & dosage Papillomavirus Vaccines - immunology Randomization Randomized Controlled Trials as Topic Schedules Studies Systematic review Vaccination - methods Vaccine Vaccines Womens health |
| title | Efficacy and immunogenicity of a single dose of human papillomavirus vaccine compared to no vaccination or standard three and two-dose vaccination regimens: A systematic review of evidence from clinical trials |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T12%3A46%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20immunogenicity%20of%20a%20single%20dose%20of%20human%20papillomavirus%20vaccine%20compared%20to%20no%20vaccination%20or%20standard%20three%20and%20two-dose%20vaccination%20regimens:%20A%20systematic%20review%20of%20evidence%20from%20clinical%20trials&rft.jtitle=Vaccine&rft.au=Whitworth,%20Hilary%20S.&rft.date=2020-02-05&rft.volume=38&rft.issue=6&rft.spage=1302&rft.epage=1314&rft.pages=1302-1314&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2019.12.017&rft_dat=%3Cproquest_cross%3E2346354140%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2346354140&rft_id=info:pmid/31870572&rft_els_id=S0264410X19316597&rfr_iscdi=true |