The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus

Dhar, J. Patricia; Essenmacher, Lynnette; Dhar, Renee; Magee, Ardella; Ager, Joel W.; Sokol, Robert J.

doi:10.1016/j.vaccine.2017.04.001

Cited by 42 publications

(26 citation statements)

References 38 publications

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“…The combined analysis of mild AEFV (similar to the HC group) and stable disease activity throughout the study showed that the 3-dose scheme of qHPV vaccine was safe in this JDM cohort. Our results are in accordance with other studies that showed no in uence of HPV vaccines regarding AEFV and disease activity in patients with AID (8,29,30,(42)(43)(44)(45).…”

Section: Discussionsupporting

confidence: 93%

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Grein¹,

Pinto

Groot

et al. 2020

Preprint

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Background: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients.Methods: JDM patients aged from 9-20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, one month after the second and third doses, and six months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study.Results: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.Conclusions: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.Trial registration: Brazilian Clinical Trials Registry, number: RBR-9ypbtf, link: http://www.ensaiosclinicos.gov.br/rg/RBR-9ypbtf/. Registered 20 March 2018 – Retrospectively registered.

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Section: Discussionsupporting

confidence: 93%

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Grein¹,

Pinto

Groot

et al. 2020

Preprint

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“…Whereas there is still no data on the efficacy of HPV vaccination in patients with AIIRD, new data on the vaccine immunogenicity in patients with SLE was published since 2010. Overall, the immunogenicity of the HPV vaccine was similar in patients with SLE and controls, without significant safety signals in patients with SLE 30 177–179. Notably, concerns regarding the safety of HPV vaccine have been raised based by case reports and case series on the onset of autoimmune diseases following HPV vaccination 180–185.…”

Section: Resultsmentioning

confidence: 99%

2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases

et al. 2019

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To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumatic drugs on the response to vaccines; effect of vaccination of household of AIIRDs patients. Subsequently, recommendations were formulated based on the evidence and expert opinion. The updated recommendations comprise six overarching principles and nine recommendations. The former address the need for an annual vaccination status assessment, shared decision-making and timing of vaccination, favouring vaccination during quiescent disease, preferably prior to the initiation of immunosuppression. Non-live vaccines can be safely provided to AIIRD patients regardless of underlying therapy, whereas live-attenuated vaccines may be considered with caution. Influenza and pneumococcal vaccination should be strongly considered for the majority of patients with AIIRD. Tetanus toxoid and human papilloma virus vaccination should be provided to AIIRD patients as recommended for the general population. Hepatitis A, hepatitis B and herpes zoster vaccination should be administered to AIIRD patients at risk. Immunocompetent household members of patients with AIIRD should receive vaccines according to national guidelines, except for the oral poliomyelitis vaccine. Live-attenuated vaccines should be avoided during the first 6 months of life in newborns of mothers treated with biologics during the second half of pregnancy. These 2019 EULAR recommendations provide an up-to-date guidance on the management of vaccinations in patients with AIIRD.

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“…17 The subjects included in this trial consisted of 34 women ages 18–50 years with a history of mild to moderate SLE (fulfilling American College of Rheumatology (ACR) criteria for SLE) with minimally active or inactive disease who consented and completed the study. 38-40 This phase I study was approved by the Human Investigation Committee and Institutional Review Board (IRB #051012PH1F) at Wayne State University and the U.S. Food & Drug Administration (FDA) under investigational new drug (IND) application BB14113 for Gardasil® (Merck & Co., Inc.) with a local Data Safety Monitoring Board (DSMB) to monitor the study.…”

Section: Methodsmentioning

confidence: 99%

“…We recently published results from a clinical trial which showed that the quadrivalent HPV vaccine was safe and immunogenic in women with SLE. 17 High-risk groups, such as Blacks, who are already disproportionately affected by both SLE and cervical cancer may benefit from HPV vaccines (even after being exposed to different oncologic strains) which prevent cervical cancer, a cancer that kills Black women more than any other racial group in America.…”

Section: Introductionmentioning

confidence: 99%

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

Dhar

Essenmacher

Dhar

et al. 2018

Human Vaccines & Immunotherapeutics

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Objective : To determine if natural human papillomavirus (HPV) infection would induce an anamnestic response to quadrivalent (qHPV) vaccine in women with Systemic Lupus Erythematosus (SLE). Methods: Thirty four women (19-50 years) with mild to moderate and minimally active or inactive SLE received standard qHPV vaccine. Neutralizing antibody titers to HPV 6, 11, 16 and18 were evaluated pre- and post- vaccine using HPV competitive Luminex Immunoassay. For each HPV type, logistic regressions were performed to explore the relationship between a positive titer at baseline with their final geometric mean titer and with the rise in titer. Fisher's Exact Test was used to assess the association of at least one positive HPV antibody test at baseline and history of abnormal pap. Results: History of abnormal pap smear/cervical neoplasia occurred in 52.9%. Baseline anti HPV antibody titers: 21% = negative for all 4 HPV types, 79% = positive for ≥1 of the HPV types. Statistical analysis showed: those with a history of abnormal pap smear/cervical neoplasia were likely to have a positive anti-HPV antibody result pre-vaccine to ≥ 1 of the 4 types, p = 0.035 Fisher's Exact Test. In general, HPV exposed women showed higher post vaccine GMTs than HPV unexposed women with higher point estimates. However, when examining the rise in titers using logistic regression, there was no evidence of an anamnestic response. Conclusion: Prior HPV infection and cervical neoplasia in SLE are linked with no anamnestic response to HPV vaccine. This supports not checking HPV-antibodies pre-vaccine. Women with SLE should be vaccinated for HPV.

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The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus

Cited by 42 publications

References 38 publications

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

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