Polyethylene Glycol Immunogenicity: Theoretical, Clinical, and Practical Aspects of Anti-Polyethylene Glycol Antibodies

Chen, Bing‐Mae; Cheng, Tian‐Lu; Roffler, Steve R.

doi:10.1021/acsnano.1c05922

Cited by 288 publications

(259 citation statements)

References 227 publications

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“…Our second objective was to evaluate whether mRNA vaccines, only recently approved for emergency use authorization, have a peculiar pattern in determining this side effect as compared to viral vector or inactivated virus vaccines. Noticeably, mRNA-based vaccine uses lipid nanoparticles to facilitate mRNA transport into cells and contain several excipients and lipids, including polyethylene glycol (PEG), which might induce immune response in predisposed individuals [ 54 ] and has been linked with cases of anaphylactic reaction to mRNA vaccine [ 55 ]. Peculiarly, all patients with a previous diagnosis of autoimmune thyroid disease who developed SAT belonged to the mRNA vaccine group, possibly identifying a predisposition to develop SAT after mRNA-based SARS-CoV-2 vaccine secondary to ASIA syndrome, which is often associated to a personal or familial history of autoimmune diseases [ 19 ], but further studies and larger cohorts are needed to verify this suggestion.…”

Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 vaccine-associated subacute thyroiditis: insights from a systematic review

Ippolito¹,

Gallo²,

Rossini

et al. 2022

J Endocrinol Invest

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Purpose To perform a systematic review on published cases of subacute thyroiditis (SAT) secondary to SARS-CoV-2 vaccination, to highlight main features and increase the awareness of this condition. Methods Original reports of SAT developed after SARS-CoV-2 vaccination (mRNA, viral vector, or inactivated virus vaccines) were retrieved from a search of electronic databases. Individual patient data on demographics, medical history, type of vaccine, workup and therapies were collected. Wilcoxon rank-sum, Kruskal–Wallis and chi-squared tests were employed for comparisons. Results 30 articles including 48 reports were retrieved, 3 additional cases evaluated by the Authors were described and included for analysis. Of the 51 patients, 38 (74.5%) were women, median age was 39.5 years (IQR 34–47). Patients developed SAT after a median of 10 days (IQR 4–14) after the vaccine shot. Baseline thyroid exams revealed thyrotoxicosis in 88.2% of patients, decreasing at 31.6% at follow-up. Corticosteroids were used in 56.4% of treated patients. Patients undergoing non-mRNA vaccines were most frequently Asian (p = 0.019) and reported more frequently weight loss (p = 0.021). All patients with a previous diagnosis of thyroid disease belonged to the mRNA vaccine group. Conclusion SARS-CoV-2 vaccine-associated SAT is a novel entity that should be acknowledged by physicians. Previous history of thyroid disease may predispose to develop SAT after mRNA vaccines, but further studies and larger cohorts are needed to verify this suggestion. SARS-CoV-2 vaccine-associated SAT is usually of mild/moderate severity and could be easily treated in most cases, thus it should not raise any concern regarding the need to be vaccinated.

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Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 vaccine-associated subacute thyroiditis: insights from a systematic review

Ippolito¹,

Gallo²,

Rossini

et al. 2022

J Endocrinol Invest

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“…Because c-JO4 is a viral protein, adaptive immune responses are likely to develop—particularly after repeated injection. Furthermore, Doxil contains a polyethylene glycol (PEG) coat, which, potentially can trigger anti-PEG antibody responses 21 . To assess the safety of repeated c-JO4/Doxil treatment, we designed a study in two female cynomolgus monkeys that closely reflected the treatment regimen planned in ovarian cancer patients (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Doxil concentration in serum was measured using an ELISA with anti-PEG monoclonal antibodies 21 (Fig. 6 A).…”

Section: Resultsmentioning

confidence: 99%

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Translational development of a tumor junction opening technology

Kim

Wang

et al. 2022

Sci Rep

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Our goal is to overcome treatment resistance in ovarian cancer patients which occurs in most cases after an initial positive response to chemotherapy. A central resistance mechanism is the maintenance of desmoglein-2 (DSG2) positive tight junctions between malignant cells that prevents drug penetration into the tumor. We have generated JO4, a recombinant protein that binds to DSG2 resulting in the transient opening of junctions in epithelial tumors. Here we present studies toward the clinical translation of c-JO4 in combination with PEGylated liposomal doxorubicin/Doxil for ovarian cancer therapy. A manufacturing process for cGMP compliant production of JO4 was developed resulting in c-JO4. GLP toxicology studies using material from this process in DSG2 transgenic mice and cynomolgus macaques showed no treatment-related toxicities after intravenous injection at doses reaching 24 mg/kg. Multiple cycles of intravenous c-JO4 plus Doxil (four cycles, 4 weeks apart, simulating the treatment regimen in the clinical trial) elicited antibodies against c-JO4 that increased with each cycle and were accompanied by elevation of pro-inflammatory cytokines IL-6 and TNFα. Pretreatment with steroids and cyclophosphamide reduced anti-c-JO4 antibody response and blunted cytokine release. Our data indicate acceptable safety of our new treatment approach if immune reactions are monitored and counteracted with appropriate immune suppression.

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“…Many factors, such as molecular size of PEG, linker type, or PEG grafting density on the nanoparticle surface, are implicated in the potential APA response. 103 This could influence the final in vivo applications.…”

Section: Discussionmentioning

confidence: 99%

One-Step Preparation of Highly Stable Copper–Zinc Ferrite Nanoparticles in Water Suitable for MRI Thermometry

et al. 2022

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Superparamagnetic ferrite nanoparticles coated with a polymer layer are widely used for biomedical applications. The objective of this work is to design nanoparticles as a magnetic resonance imaging (MRI) temperature-sensitive contrast agent. Copper–zinc ferrite nanoparticles coated with a poly(ethylene glycol) (PEG) layer are synthesized using a one-step thermal decomposition method in a polymer matrix. The resulting nanoparticles are stable in water and biocompatible. Using Mössbauer spectroscopy and magnetometry, it was determined that the grown nanoparticles exhibit superparamagnetic properties. Embedding these particles into an agarose gel resulted in significant modification of water proton relaxation times T 1 , T 2 , and T 2 * determined by nuclear magnetic resonance measurements. The results of the spin-echo T 2 -weighted MR images of an aqueous phantom with embedded Cu 0.08 Zn 0.54 Fe 2.38 O 4 nanoparticles in the presence of a strong temperature gradient show a strong correlation between the temperature and the image intensity. The presented results support the hypothesis that CuZn ferrite nanoparticles can be used as a contrast agent for MRI thermometry.

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Polyethylene Glycol Immunogenicity: Theoretical, Clinical, and Practical Aspects of Anti-Polyethylene Glycol Antibodies

Cited by 288 publications

References 227 publications

SARS-CoV-2 vaccine-associated subacute thyroiditis: insights from a systematic review

SARS-CoV-2 vaccine-associated subacute thyroiditis: insights from a systematic review

Translational development of a tumor junction opening technology

One-Step Preparation of Highly Stable Copper–Zinc Ferrite Nanoparticles in Water Suitable for MRI Thermometry

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