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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
Open accessAbstract
OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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“Notably, the IARC India trial with a quadrivalent vaccine, and the Costa Rica Trial with a bivalent vaccine, have shown comparable efficacy between single-dose and multi-dose schedules, with sustained antibody levels for at least 11 years after vaccination.”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [10]
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“which currently provides the best data on single-dose protection because of its long follow-up and near-random assignment of participants to different dose schedules.10, 11”
From Evidence-based impact projections of single-dose human papillomavirus vaccination in India: a modelling study (2022) · cites this paper as [10]
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Metadata
- Authors
- Whitworth, H. S., Gallagher, K. E., Howard, N., Mounier-Jack, S., Mbwanji, G., Kreimer, A. R., Basu, P., Kelly, H., Drolet, M., Brisson, M., & Watson-Jones, D.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Mwanza Intervention Trials Unit (TZ)
- National Institutes of Health (US)
- Centre international de recherche sur le cancer (FR)
- Centre de recherche du CHU de Québec-Université Laval (CA)
- Université Laval (CA)
- Corresponding author
- Whitworth, Hilary S.
- ORCID
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2020-02
- Volume
- 38
- Issue
- 6
- Pages
- 1302-1314
- ISSN
- 0264-410X (ISSN-L)
- OpenAlex
- W2995954663
- Cited by
- 118
- References
- 34
- Citations by year
- 2026: 9 · 2025: 20 · 2024: 25 · 2023: 20 · 2022: 19 · 2021: 17 · 2020: 8
- FWCI
- 1.60
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Vaccine (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- National University of Singapore (submittedVersion)
- Funders
- PATH
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Surgery › Genital Health and Disease
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- HPV vaccine, single-dose vaccination, HPV16/18 infection, immunogenicity, vaccine efficacy, dosing regimen, seropositivity, antibody levels, HPV prevention, young women
- MeSH terms
- Immunogenicity, Vaccine, Female, Humans, Immunization Schedule, Vaccination, Randomized Controlled Trials as Topic, Papillomavirus Infections, Human papillomavirus 18, Human papillomavirus 16, Papillomavirus Vaccines, Immunity, Humoral, Observational Studies as Topic
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