Vaccination with Fendrix of prior nonresponding patients with HIV has a high success rate

Machiels, Julian D; Braam, Esmee E.; Bentum, Petra van; Vugt, Michèle van; Vries-Sluijs, Theodora E. M. S. de; Schouten, Ineke W. E. M.; Bierman, Wouter F W; Gisolf, Elisabeth H.

doi:10.1097/qad.0000000000002085

Cited by 9 publications

(2 citation statements)

References 15 publications

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“…The data in the medical literature regarding efficacy and safety of HBV-AS04 are scarce and preliminary in nature (Table 5). Evidence exists in some patient groups including HIV-positive patients [20], renal transplant recipients [17] and non-responder patients with intact kidneys [21]. Fendrix TM has always shown a high level of immunogenicity.…”

Section: Discussionmentioning

confidence: 99%

HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population

Fabrizi¹,

Cerutti²,

Nardelli³

et al. 2020

Clinics and Research in Hepatology and Gastroenterology

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Background: Patients with chronic kidney disease have a poor response to hepatitis B vaccine due to the immunodeficiency conferred from chronic uremia. A recombinant HB vaccine containing an improved adjuvant system AS04 (HBV-AS04) has been manufactured but scarce evidence exists on HBV-AS04 use among patients with CKD. Aim: To assess efficacy and safety of an adjuvanted recombinant vaccine (HBV-AS04) in a large cohort of CKD patients at pre-dialysis stage (with susceptibility to HBV infection). Methods: Patients were prospectively enrolled to receive four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 1, 2, 3, and 4. Anti-HBs surface antibody concentrations were tested at intervals of 1, 2, 3, 4, and 12 months. Multivariate analyses were performed to assess the parameters, which predicted immunologic response to HBV-AS04 vaccine. Results: One hundred and seven patients were included and 102 completed the study. At completion of vaccine schedule, the frequency of responders (anti-HBs titers ≥ 10 mIU/mL) was 95% (97/102) (mean anti-HBs antibody titers, 688.9 ± 385 mIU/mL), according to per-protocol analysis. Serum haemoglobin levels were greater in responder than non-or low-responder patients to HBV-AS04 (P = 0.04) and this was confirmed by multivariate analysis. The seroprotection rate at month 50 was 88% (30/34) with lower anti-HBs antibody titers (218.5 ± 269.6 mIU/mL, P = 0.001). No major side effects were observed. Conclusions: Our prospective study performed in a real-world setting showed a high immunogenicity and safety of HBV-AS04 vaccine in patients with CKD not yet on maintenance dialysis. Studies provided with longer follow-ups are under way to assess the durability of seroprotection in responders.

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Section: Discussionmentioning

confidence: 99%

HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population

Fabrizi¹,

Cerutti²,

Nardelli³

et al. 2020

Clinics and Research in Hepatology and Gastroenterology

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“…Fendrix Ò , the hepatitis B vaccine formulated with the new AS04 adjuvant (MPL + aluminum salts) by GlaxoSmithKline, may provide a good alternative [19,[26][27][28]. The vaccine is indicated for patients with renal insufficiency, especially those on hemodialysis and pre-hemodialysis aged over 15 years old [19,22,[28][29][30][31][32][33][34][35]. It has been reported that revaccination with Fendrix Ò has a high success rate in HIV patients who do not respond to other vaccination strategies against hepatitis B [30,[34][35].…”

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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Viral protein-based nanoparticles (part 2): Pharmaceutical applications

Mellid-Carballal,

Gutierrez-Gutierrez,

Rivas

et al. 2023

European Journal of Pharmaceutical Sciences

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Vaccination with Fendrix of prior nonresponding patients with HIV has a high success rate

Cited by 9 publications

References 15 publications

HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population

HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population

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

Viral protein-based nanoparticles (part 2): Pharmaceutical applications

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