Abstract
Abstract
Introduction
The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.
Methods and analysis
A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.
Ethics and dissemination
This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.
PROSPERO registration number
CRD42023452537.
Keywords: HPV Vaccine, HIV & AIDS, Infectious disease/HIV
STRENGTHS AND LIMITATIONS OF THIS STUDY.
This systematic review and meta-analysis will integrate data from studies reporting effect sizes that are comparable and amenable to quantitative synthesis.
Following the selection of eligible studies, two reviewers will independently perform data extraction and assess the risk of bias using standardised criteria.
A limited sample size and a small number of included studies may potentially constrain the robustness, validity and generalisability of the findings.
Introduction
The problem, condition or issue and why it is important to do this review
The development of highly effective vaccines targeting human papillomavirus (HPV) has provided a valuable tool for the prevention of HPV-related diseases. However, HPV vaccine acceptance and uptake among immunosuppressed individuals present unique considerations and challenges.1 Immunosuppressed patients are a heterogeneous group characterised by compromised immune responses, which make them more susceptible to infections and HPV-related complications.2 Immunosuppression may result from various conditions and treatments, including organ transplantation—where immunosuppressive drugs are routinely administered to prevent graft rejection—as well as from cancer therapies such as chemotherapy and radiation, which can induce temporary or prolonged immune suppression.3
Moreover, individuals living with HIV represent a significant subgroup with heightened vulnerability to persistent HPV infection and related malignancies.4
Despite their increased risk, HPV vaccination coverage among immunosuppressed patients remains suboptimal. Barriers to acceptance in this population include concerns about vaccine safety and efficacy, fear of interactions with immunosuppressive medications, lack of awareness about vaccine benefits in the context of immune compromise and limited or unclear recommendations from healthcare providers.5 Cultural beliefs, prior experiences with healthcare systems and the quality of communication between patients and clinicians further influence decision-making. In this regard, access to accurate information and tailored educational interventions is crucial to promoting HPV vaccine uptake among these high-risk groups.6,8
Vaccine hesitancy, defined by the Strategic Advisory Group of Experts as the ‘delay in acceptance or refusal of vaccination despite availability of vaccination services’, is a complex and context-specific phenomenon that varies across time, place and vaccines. It is influenced by factors such as complacency, convenience and confidence, and must be examined within the social, cultural and clinical context of the population in question. In immunosuppressed individuals, these factors may manifest differently due to their unique health circumstances, underlying conditions and frequent healthcare interactions, underscoring the importance of targeted investigation within this group.9
The safety and efficacy of HPV vaccination in immunosuppressed populations—particularly people living with HIV and solid organ transplant recipients—has been evaluated in multiple clinical trials and systematic reviews. Across studies, HPV vaccines are consistently safe and well tolerated in immunosuppressed individuals. Local injection site reactions are common but generally mild to moderate in intensity, and the incidence of serious adverse events is not increased compared with placebo or the general population. No significant impact on HIV viral load or CD4+T cell count has been observed following vaccination in people with HIV. In children and adults with various causes of immunosuppression, including solid organ transplantation, the safety profile remains favourable.10,12
Focusing this review on immunosuppressed populations is particularly important because this group not only faces a higher burden of HPV-related morbidity but also tends to be under-represented in vaccination campaigns and clinical studies. The complexity of their care, frequent interactions with specialised healthcare services and specific safety concerns make it essential to understand the unique determinants that influence vaccine acceptance in this context. A better understanding of these factors is critical to guiding individualised vaccination strategies and optimising preventive care in an already vulnerable population.
Given the critical importance of improving vaccination strategies for immunosuppressed populations, understanding the factors that facilitate or hinder vaccine acceptance is essential. Although previous studies have explored HPV vaccine hesitancy in general populations, few have specifically addressed this issue in immunocompromised individuals. To address this gap, a systematic review is warranted. Unlike a scoping review, which aims to broadly map existing literature, a systematic review allows for a more focused and comprehensive synthesis of findings regarding specific factors influencing vaccine acceptance, as well as the strength and consistency of these associations. This approach will enable the identification of evidence-based patterns, inform clinical practice and guide the development of tailored interventions for vaccine promotion in immunosuppressed patients.
Furthermore, it is worthwhile to emphasise understanding the factors that contribute to HPV vaccination in these patients holds significant importance from a public health perspective. This, in turn, enables the contemplation of strategies for enhancing vaccination implementation, while also representing a valuable contribution to the realm of public health.
Therefore, considering the above-mentioned, it becomes evident that there is a clear need for meticulous assessment of this population group, given the significance of the subject matter, because understanding and addressing these influencing factors can contribute to improving vaccine uptake and ultimately enhance the protection against HPV-related diseases in this vulnerable population.
Objectives
This systematic review aims to assess the primary factors influencing the adherence (or not) to HPV vaccination among the immunocompromised patient group.
In this regard, we will seek to answer the following research questions:
What are the main factors influencing the acceptance of the HPV vaccine in immunosuppressed patient populations?
How does the level of immunocompromise impact the acceptance and completion of HPV vaccination among this patient group, based on findings from previous research?
Are there disparities in HPV vaccination rates and adherence among immunocompromised patients, and if so, what socio-demographic, healthcare access or healthcare provider-related factors contribute to these disparities?
Methods
Criteria for considering studies for this review
In this review, we will incorporate research related to HPV vaccines and their administration. The analysis will encompass the three prophylactic HPV vaccines currently endorsed by the WHO: the quadrivalent, bivalent and nonavalent vaccines. Any studies referring to ‘HPV vaccine(s)’ without specifying a particular type will also be considered for inclusion.
Additionally, we will encompass all studies, regardless of the vaccine dosage, vaccination schedule or specific vaccination setting focused on. We will include any comparator related to the type of HPV vaccine or studies comparing the intervention with a non-exposed control group. The eligible studies will be observational studies, such as: retrospective or prospective cohorts, case–control and cross-sectional studies, reporting at least one factor influencing the vaccination of HPV in immunosuppressed populations. In this review, we focus on immunosuppressed patients.
Therefore, we will include studies that address interventions for the acceptance of the HPV vaccine in populations of immunosuppressed patients, namely: (1) patients who receive organ transplants, (2) who are under oncological treatment or (3) who are HIV positive patients. We will exclude studies with overlapping patient populations. The phenomena of interest of this review are the factors influencing HPV vaccination in immunocompromised patients, and the main outcomes will be any factor found in the target studies that is related to acceptance of the HPV vaccine in this population. No temporal restrictions will be applied, and searches will be conducted until December 2025. Therefore, according to the PICOT question, our study will assess:
P: immunosuppressed patients.
I: HPV vaccine.
C: non-exposed patients or any control group reported.
O: factors influencing the acceptance of the HPV vaccine.
T: observational studies, without time restriction.
Search methods for identification of studies
A comprehensive search will be conducted across various databases, including MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences (LILACS), Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Cochrane Database of Systematic Reviews. Additionally, the exploration of ‘Grey literature’ will encompass sources such as Google Scholar and opengrey.eu.
The screening criteria for references will be meticulously determined. Both publication date and language restrictions will be absent. The literature search will be performed collaboratively by two independent reviewers. A primary search strategy will be formulated by an information specialist (RH), involving a combination of search terms encompassing both MeSH (medical subject headings) and free-text terms. These terms will include: “papillomavirus infections”, “papillomavirus vaccines”, “HPV”, “HPV vaccine”, “human papillomavirus”, “immunosuppression’, “immune tolerance”, “immunosuppression therapy”, “immunosuppressed population”, “organ transplant”, “organ transplantation”, “kidney transplant”, “bone marrow transplant”, “acquired immunodeficiency syndrome”, “AIDS”, “human immunodeficiency virus” and “HIV” (online supplemental file 1).
Patient and public involvement
The individual patient data will not be presented. A literature search will be carried out from defined databases. No patient will be involved in the study planning and application process during neither the analysis nor the dissemination of results.
Selection of studies
Our document management approach involves using Rayyan for efficient handling of retrieved materials during the search phase. Prior to screening, all duplicates will be removed within Zotero. Subsequently, all citations will be imported into Rayyan. Primary screening of titles and abstracts will be independently conducted by two reviewers, categorising articles as relevant, irrelevant or unsure.
Exclusion of articles as irrelevant will occur when consensus is reached between both reviewers. A compilation of potentially included articles will be assembled, and any disagreements will be resolved through consensus discussions involving the third reviewer or the entire team. Subsequently, the selected studies will be submitted to independent assessment by two reviewers for eligibility based on predetermined criteria.
Studies that fail to meet inclusion criteria will be excluded and accompanied by reasons for their exclusion. In case of discrepancies, resolution will be achieved through consultation with a third reviewer. Moreover, multiple publications or reports of the same instrument will be duly examined and reported. The comprehensive screening and selection process will be transparently documented in the final report, presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram (figure 1).
Figure 1. PRISMA flow diagram. HPV, human papillomavirus; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Data extraction and management
An established data extraction template will be devised and subjected to validation. Independent data extraction will be conducted by two reviewers (CHAdS, GMM) for each eligible study, with discrepancies addressed through consultation with a third reviewer (LMCS). The extracted data will encompass authorship details, publication year, study locale (both country and continent), study design, primary objectives, participant demographics, specific HPV vaccine type, identified risk and protective factors, patient outcomes and pertinent medical history.
Additionally, participant attributes (such as mean age) and prevalence results will be documented. In cases of absent or ambiguous data, direct communication with study authors will be initiated to ensure completeness and clarity. Supplementary data will also be duly recorded. Rigorous cross-verification will be applied to all data entries.
Should a collection of articles exhibit analogous characteristics based on the data extraction synopsis, a meta-analysis using a random-effects model will be undertaken. In instances where data interpretation is ambiguous in certain articles, correspondence with the lead author will be established to solicit potential elucidation.
Assessment of risk of bias
We will use the ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions)13 to assess the quality of observational studies, and the GRADE (Grading of Recommendations Assessment, Development and Evaluation)14 to rate the certainty of evidence in this systematic review.
Synthesis procedures and statistical analysis
The systematic review and subsequent meta-analysis will adhere to the guidelines and recommendations established by the Cochrane Collaboration and will be aligned with the principles elucidated in the PRISMA statement.15
When feasible, the meta-analysis will involve the comparison of binary endpoints, employing pooled risk ratios or ORs accompanied by 95% CIs. The assessment of heterogeneity will encompass the Cochran Q test and I² statistics, where significance levels of p<0.10 and I²> 25% will serve as discernible indicators of substantial heterogeneity.
Outcomes characterised by minimal heterogeneity (I²≤25%) will be subjected to analysis through a fixed-effect model. Conversely, aggregated results displaying pronounced heterogeneity will undergo examination via the DerSimonian and Laird random-effects model. For statistical computations, Review Manager V.5.4, a software provided by the Nordic Cochrane Centre of The Cochrane Collaboration based in Copenhagen, Denmark, will be employed.
Discussion
Immunocompromised patients, encompassing a diverse group with conditions such as organ transplantation, HIV-positive patients or undergoing cancer treatments, face a heightened vulnerability to infections due to their compromised immune systems.16 In the context of HPV vaccination, their acceptance and adherence to this preventive measure are influenced by a complex interplay of factors. One pivotal concern is the safety and effectiveness of the HPV vaccine within this patient population.17 Given their susceptibility to infections, immunocompromised individuals often possess heightened concerns regarding the vaccine’s safety and ability to provide adequate protection in light of their weakened immune response.
Another critical aspect that significantly influences the decision to vaccinate among immunocompromised patients is the potential interaction between HPV vaccines and immunosuppressive medications.18 19 The delicate balance between managing their underlying condition and protecting against HPV-related diseases can be intricate. Healthcare providers must carefully consider the patient’s medical history, current medications and the vaccine’s compatibility with their treatment plan. Moreover, individualised recommendations may be necessary to mitigate potential interactions and optimise the vaccine’s benefits.20
Immunosuppression in HIV-positive patients significantly influences the acceptability and effectiveness of the HPV vaccine. These individuals have compromised immune systems due to HIV infection, which makes them more susceptible to various infections and can impact their response to vaccinations, including the HPV vaccine.21 The weakened immune response in HIV-positive individuals may result in decreased vaccine efficacy.
Furthermore, healthcare providers should communicate the importance of HPV vaccination to HIV-positive patients, emphasising its role in preventing HPV-related cancers, particularly anal and oropharyngeal cancers, which are more prevalent in this population.22 Despite potential challenges posed by immunosuppression, the HPV vaccine remains a crucial preventive measure. Strategies such as vaccine scheduling to coincide with CD4 cell count improvements, careful monitoring of vaccine responses and the consideration of booster doses may help optimise vaccine effectiveness in HIV-positive individuals.
Additionally, addressing any concerns or misconceptions about vaccine safety and potential interactions with antiretroviral medications can enhance vaccine acceptability.23 Ultimately, a tailored and informed approach to HPV vaccination in HIV-positive patients, accounting for their specific immunosuppressive status, is essential to maximise its protective benefits and improve their overall health outcomes.
Tailored interventions to increase vaccination coverage in adults with immunosuppression should be multifaceted and integrated into clinical workflows, with a focus on addressing both patient-level and system-level barriers. The medical literature highlights several effective strategies: Embedding vaccination protocols into routine care—such as nurse-led or team-based workflows with standing orders and electronic health record (EHR) prompts—has been shown to substantially increase vaccination rates in immunosuppressed adults, including those with cancer and those on immunosuppressive therapies. These protocols should include systematic screening for vaccine eligibility at each visit, immediate vaccine availability and administration before the patient leaves the clinic. Nursing staff play a critical role in both assessment and patient education, reinforcing vaccine safety and efficacy during immunosuppressive treatment.24 Direct, personalised education from clinicians that addresses individual concerns and misconceptions about vaccines is highly effective, particularly in overcoming vaccine hesitancy. Engaging in patient-centred dialogue, exploring specific barriers and providing immediate access to vaccination following the discussion can dramatically improve uptake, even among those initially declining vaccinations.25
Use of reminders—via phone calls, text messages or EHR alerts—has been shown to increase vaccine uptake in adults. These systems are particularly important for multidose vaccines and for populations with complex care needs, such as those with immunosuppression.26 27
Ensuring vaccines are available at the point of care, minimising out-of-pocket costs and streamlining the vaccination process (eg, walk-in availability, extended hours) are critical. These measures are especially important for immunosuppressed adults, who may have frequent healthcare encounters but competing clinical priorities.26 28
Provider prompts, audit and feedback, and quality improvement initiatives—such as benchmarking vaccination rates and incentivising providers—can further enhance coverage. Integrating vaccination status into routine clinical assessments and leveraging EHRs to track and prompt vaccination needs are effective system-level strategies.24 26 27
Interventions should be adapted to the specific needs of subpopulations, considering language, cultural beliefs and health literacy. Multicomponent interventions that address knowledge, attitudes and practical barriers are most effective, particularly in diverse or underserved populations.26 29 30
Sustained improvements require institutional support for ongoing quality improvement, standardised processes for vaccination assessment and regular training for staff to address evolving challenges, such as new immunosuppressive therapies or emerging vaccine hesitancy.24 The most effective tailored interventions for increasing vaccination coverage in immunosuppressed adults are those that combine protocol-driven, team-based care with patient-centred education, robust reminder systems and strategies to reduce access barriers, all adapted to the unique needs of the target population.24,2629 30
Despite the challenges posed by compromised immunity, the development of highly effective HPV vaccines has revolutionised disease prevention. However, ensuring equitable access and successful administration of these vaccines in immunosuppressed individuals remains a substantial challenge. Future research should focus on tailoring vaccine communication strategies and exploring innovative approaches to vaccine administration to address the unique needs of this vulnerable population effectively. Ultimately, this can contribute to reducing the burden of HPV-related diseases and enhancing the quality of life for immunocompromised patients.
The strengths of this research will be that a meta-analysis combines the results of multiple studies, providing a more robust overview of the factors that influence HPV vaccine acceptance in this population. By aggregating data, it increases the precision of estimates, helping to better understand the proportion of people who accepted or rejected the vaccine. It can reveal common factors or differences between groups, helping to identify which instructions may be most effective. It provides reliable information that can guide public health strategies and vaccination campaigns specific to this population.
We must consider some limitations of this study. The fact that differences in studies, such as methods, populations or contexts, can make comparison and interpretation of results difficult. If the included studies have limitations or biases, this can affect the validity of the meta-analysis’ conclusions. There may be few specific studies on immunosuppressed populations, which limit the comprehensiveness and reliability of the conclusions. Some cultural, social or psychological reasons or factors that influence acceptance may not be well captured in quantitative studies, making a comprehensive analysis difficult.
Supplementary material
Footnotes
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-094224).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
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