Efficacy of a Hepatitis B Vaccination Schedule With Two Cycles of Four Double Doses of Conventional Vaccine and Four Doses of Adjuvanted Vaccine in Chronic Kidney Disease Patients Evaluated for Renal Transplantation

García-Agudo, Rebeca; Rabih, Sami Aoufi; Torres, Pilar; Fuentes, Mejía; Gámez, J. Carlos Valenzuela; Ramos, J. Mancha; Burillo, José María Tenías

doi:10.1016/j.transproceed.2012.09.046

Cited by 15 publications

(10 citation statements)

References 5 publications

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“…The scarce data available on vaccine response under immunosuppression for other vaccines leaves many open questions in relation to SARS-CoV-2 vaccination. 15 19 …”

Section: Introductionmentioning

confidence: 99%

“…As shown for several vaccines in patients with chronic inflammatory diseases and transplanted patients, antibody titres postvaccination may be decreased depending on the vaccine and the treatment (although this is not always the case). 15 19 20 In relation to SARS-CoV-2, it is currently unclear how immunosuppression for CID affects vaccine response. There are also additional concerns regarding reactivation of the inflammatory disease by new mRNA vaccines.…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort

et al. 2021

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IntroductionIn light of the SARS-CoV-2 pandemic, protecting vulnerable groups has become a high priority. Persons at risk of severe disease, for example, those receiving immunosuppressive therapies for chronic inflammatory cdiseases (CIDs), are prioritised for vaccination. However, data concerning generation of protective antibody titres in immunosuppressed patients are scarce. Additionally, mRNA vaccines represent a new vaccine technology leading to increased insecurity especially in patients with CID.ObjectiveHere we present for the first time, data on the efficacy and safety of anti-SARS-CoV-2 mRNA vaccines in a cohort of immunosuppressed patients as compared with healthy controls.Methods42 healthy controls and 26 patients with CID were included in this study (mean age 37.5 vs 50.5 years). Immunisations were performed according to national guidelines with mRNA vaccines. Antibody titres were assessed by ELISA before initial vaccination and 7 days after secondary vaccination. Disease activity and side effects were assessed prior to and 7 days after both vaccinations.ResultsAnti-SARS-CoV-2 antibodies as well as neutralising activity could be detected in all study participants. IgG titres were significantly lower in patients as compared with controls (2053 binding antibody units (BAU)/mL ±1218 vs 2685±1102). Side effects were comparable in both groups. No severe adverse effects were observed, and no patients experienced a disease flare.ConclusionWe show that SARS-CoV-2 mRNA vaccines lead to development of antibodies in immunosuppressed patients without considerable side effects or induction of disease flares. Despite the small size of this cohort, we were able to demonstrate the efficiency and safety of mRNA vaccines in our cohort.

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“…The scarce data available on vaccine response under immunosuppression for other vaccines leaves many open questions in relation to SARS-CoV-2 vaccination. 15 19 …”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort

et al. 2021

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“…Fifteen years after vaccination, the team tested all subjects for antibodies that would protect them from infection and found that the number of antibodies against the virus had fallen since vaccination. The factors associated with a greater likelihood of continuing to present high antibody levels at 15 years were: being male, being older at the time of vaccination and having developed a high number of antibodies at the start [8][9][10][14][15][16][17][18][19][20][21][22][23][24].…”

Section: Scientific Background and Rationalementioning

confidence: 99%

Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines

Bravo-Grande

Blanco-González

Torre-Robles

et al. 2021

Vaccine

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An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. Inclusion Criteria: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)-classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix Ò dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. Results: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix Ò , administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first

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“…Some experts have recommended additional doses and/or boosters to improve serological response in CKD patients. García-Agudo et al[11] measured serological response in 155 CKD patients prospectively with two cycles of four double doses of conventional hepatitis B vaccine (at 0, 1, 2 and 6 mo), and additional four 20 mg dose of adjuvant vaccine in non-responders. Serological response was improved to 93.8% after the eighth dose compared to 75.9% after the fourth dose.…”

Section: Pre-transplant Vaccinationsmentioning

confidence: 99%

Vaccinations in kidney transplant recipients: Clearing the muddy waters

Arora

Kipp

Bhanot

et al. 2019

WJT

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Vaccine preventable diseases account for a significant proportion of morbidity and mortality in transplant recipients and cause adverse outcomes to the patient and allograft. Patients should be screened for vaccination history at the time of pre-transplant evaluation and vaccinated at least four weeks prior to transplantation. For non-immune patients, dead-vaccines can be administered starting at six months post-transplant. Live attenuated vaccines are contraindicated after transplant due to concern for infectious complications from the vaccine and every effort should be made to vaccinate prior to transplant. Since transplant recipients are on life-long immunosuppression, these patients may have lower rates of serological conversion, lower mean antibody titers and waning of protective immunity over shorter period as compared to general population. Recommendations regarding booster dose in kidney transplant recipients with sub-optimal serological response are lacking. Travel plans should be part of routine post-transplant assessment and pre-travel vaccines and counseling should be provided. More studies are needed on vaccination schedules, serological response, need for booster doses and safety of live attenuated vaccines in this special population.

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Efficacy of a Hepatitis B Vaccination Schedule With Two Cycles of Four Double Doses of Conventional Vaccine and Four Doses of Adjuvanted Vaccine in Chronic Kidney Disease Patients Evaluated for Renal Transplantation

Cited by 15 publications

References 5 publications

Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort

Immunogenicity and safety of anti-SARS-CoV-2 mRNA vaccines in patients with chronic inflammatory conditions and immunosuppressive therapy in a monocentric cohort

Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines

Vaccinations in kidney transplant recipients: Clearing the muddy waters

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