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Article ; Online: Methods to Prepare Aluminum Salt-Adjuvanted Vaccines.

Thakkar, Sachin G / Cui, Zhengrong

Methods in molecular biology (Clifton, N.J.)

2017 Volume 1494, Page(s) 181–199

Abstract: Many human vaccines contain certain insoluble aluminum salts such as aluminum oxyhydroxide and aluminum hydroxyphosphate as vaccine adjuvants to boost the immunogenicity of the vaccines. Aluminum salts have been used as vaccine adjuvants for decades and ... ...

Abstract	Many human vaccines contain certain insoluble aluminum salts such as aluminum oxyhydroxide and aluminum hydroxyphosphate as vaccine adjuvants to boost the immunogenicity of the vaccines. Aluminum salts have been used as vaccine adjuvants for decades and have an established, favorable safety profile. However, preparing aluminum salts and aluminum salt-adjuvanted vaccines in a consistent manner remains challenging. This chapter discusses methods to prepare aluminum salts and aluminum salt-adjuvanted vaccines, factors to consider during preparation, and methods to characterize the vaccines after preparation.
Language	English
Publishing date	2017
Publishing country	United States
Document type	Journal Article
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-4939-6445-1_13
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Article: Eighteen-year survival after GD2-directed Chimeric Antigen Receptor-Modified Immune Effector Cell Treatment for Neuroblastoma.

Che-Hsing, Li / Sharma, Sandhya / Heczey, Andras A / Steffin, David H M / Louis, Chrystal U / Grilley, Bambi J / Thakkar, Sachin G / Wu, Mengfen / Wang, Tao / Rooney, Cliona M / Brenner, Malcolm K / Heslop, Helen E

Research square

2024

Abstract: We report long-term outcomes up to 18 years of a clinical trial treating children with neuroblastoma with EBV-specific T lymphocytes and CD3-activated T cells - each expressing a first-generation chimeric antigen receptor targeting GD2 with barcoded ... ...

Abstract	We report long-term outcomes up to 18 years of a clinical trial treating children with neuroblastoma with EBV-specific T lymphocytes and CD3-activated T cells - each expressing a first-generation chimeric antigen receptor targeting GD2 with barcoded transgenes to allow tracking of each population. Of 11 patients with active disease at infusion, three patients achieved a complete response that was sustained in 2, one for 8 years until lost to follow up and one for 18+ years. Of eight patients with a history of relapse or at high risk of recurrence, five are disease-free at their last follow-up between 10-14 years post-infusion. Intermittent low levels of transgene were detected during the follow up period with significantly greater persistence in those who were long-term survivors. In conclusion, patients with relapsed/refractory neuroblastoma achieved long-term disease control after receiving GD2 CAR-T cell therapy including one patient now in remission of relapsed disease for >18 years.
Language	English
Publishing date	2024-04-11
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-4232549/v1
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Article ; Online: Incipient clonal hematopoiesis is accelerated following CD30.CAR-T therapy.

Kapadia, Chiraag D / Rosas, Gerardo / Thakkar, Sachin G / Wu, Mengfen / Torrano, Virginia / Wang, Tao / Grilley, Bambi J / Heslop, Helen E / Ramos, Carlos A / Goodell, Margaret A / Lulla, Premal D

Cytotherapy

2023 Volume 26, Issue 3, Page(s) 261–265

Abstract: Chimeric antigen receptor (CAR) T-cells are an emerging therapy for refractory lymphomas. Clonal hematopoiesis (CH), the preferential outgrowth of mutated bone marrow progenitors, is enriched in lymphoma patients receiving CAR-T cells. CAR-T therapy ... ...

Abstract	Chimeric antigen receptor (CAR) T-cells are an emerging therapy for refractory lymphomas. Clonal hematopoiesis (CH), the preferential outgrowth of mutated bone marrow progenitors, is enriched in lymphoma patients receiving CAR-T cells. CAR-T therapy requires conditioning chemotherapy and often induces systemic inflammatory reactions, both of which have been shown to promote expansion of CH clones. Thus, we hypothesized that pre-existing CH clones could expand during CAR-T cell treatment. We measured CH at 154 timepoints longitudinally sampled from 26 patients receiving CD30.CAR-T therapy for CD30+ lymphomas on an investigational protocol (NCT02917083). Pre-treatment CH was present in 54% of individuals and did not correlate with survival outcomes or inflammatory toxicities. Longitudinal tracking of single clones in individual patients revealed distinct clone growth dynamics. Initially small clones, defined as VAF <1%, expanded following CAR-T administration, compared with relatively muted expansions of larger clones (3.37-fold vs. 1.20-fold, P = 0.0014). Matched clones were present at low magnitude in the infused CD30.CAR-T product for all CH cases but did not affect the product's immunophenotype or transduction efficiency. As cellular immunotherapies expand to become frontline treatments for hematological malignancies, our data indicates CAR-T recipients could be enriched for CH, and further longitudinal studies centered on CH complications in this population are warranted.
MeSH term(s)	Humans ; Receptors, Chimeric Antigen ; Clonal Hematopoiesis ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Lymphoma/therapy ; Immunotherapy ; Hematopoiesis/genetics
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2023-12-26
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2023.11.013
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Article ; Online: Uric acid and the vaccine adjuvant activity of aluminium (oxy)hydroxide nanoparticles.

Thakkar, Sachin G / Xu, Haiyue / Li, Xu / Cui, Zhengrong

Journal of drug targeting

2018 Volume 26, Issue 5-6, Page(s) 474–480

Abstract: In an effort to improve the adjuvanticity of insoluble aluminium salts, we discovered that the adjuvant activity of aluminium salt nanoparticles is significantly stronger than aluminium salt microparticles, likely related to nanoparticle's stronger ... ...

Abstract	In an effort to improve the adjuvanticity of insoluble aluminium salts, we discovered that the adjuvant activity of aluminium salt nanoparticles is significantly stronger than aluminium salt microparticles, likely related to nanoparticle's stronger ability to directly activate NACHT, LRR and PYD domains-containing protein 3 (NLRP3) inflammasome as the nanoparticles are more efficiently taken up by phagocytic cells. Endogenous signals such as uric acid from cell damage or death caused by the cytotoxicity of aluminium salts are thought to indirectly activate inflammasome, prompting us to hypothesise that the potent adjuvant activity of aluminium salt nanoparticles is also related to their ability to stimulate uric acid production. In the present study, we prepared aluminium (oxy)hydroxide nanoparticles (∼ 30-100 nm) and microparticles (X
MeSH term(s)	Adjuvants, Immunologic/administration & dosage ; Aluminum Hydroxide/chemistry ; Animals ; Female ; Inflammasomes/immunology ; Injections, Intraperitoneal ; Mice ; Mice, Inbred BALB C ; NLR Family, Pyrin Domain-Containing 3 Protein/immunology ; Nanoparticles ; Ovalbumin/immunology ; Particle Size ; Uric Acid/metabolism ; Vaccines/administration & dosage ; Vaccines/immunology
Chemical Substances	Adjuvants, Immunologic ; Inflammasomes ; NLR Family, Pyrin Domain-Containing 3 Protein ; Nlrp3 protein, mouse ; Vaccines ; Uric Acid (268B43MJ25) ; Aluminum Hydroxide (5QB0T2IUN0) ; Ovalbumin (9006-59-1)
Language	English
Publishing date	2018-01-28
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1187110-6
ISSN	1029-2330 ; 1061-186X
ISSN (online)	1029-2330
ISSN	1061-186X
DOI	10.1080/1061186X.2018.1428808
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Zs.A 4481: Show issues

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Article ; Online: The immunogenicity of thin-film freeze-dried, aluminum salt-adjuvanted vaccine when exposed to different temperatures.

Thakkar, Sachin G / Ruwona, Tinashe B / Williams, Robert O / Cui, Zhengrong

Human vaccines & immunotherapeutics

2017 Volume 13, Issue 4, Page(s) 936–946

Abstract: Insoluble aluminum salts such as aluminum oxyhydroxide have been used for decades as adjuvants in human vaccines, and many vaccines contain aluminum salts as adjuvants. Aluminum salt-adjuvanted vaccines must be managed in cold-chain (2-8° C) during ... ...

Abstract	Insoluble aluminum salts such as aluminum oxyhydroxide have been used for decades as adjuvants in human vaccines, and many vaccines contain aluminum salts as adjuvants. Aluminum salt-adjuvanted vaccines must be managed in cold-chain (2-8° C) during transport and storage, as vaccine antigens in general are too fragile to be stable in ambient temperatures, and unintentional slowing freezing causes irreversible aggregation and permanent damage to the vaccines. Previously, we reported that thin-film freeze-drying can be used to convert vaccines adjuvanted with an aluminum salt from liquid suspension into dry powder without causing particle aggregation or decreasing in immunogenicity following reconstitution. In the present study, using ovalbumin (OVA)-adsorbed Alhydrogel® (i.e. aluminum oxyhydroxide, 2% w/v) as a model vaccine, we showed that the immunogenicity of thin-film freeze-dried OVA-adsorbed Alhydrogel® vaccine powder was not significantly changed after it was exposed for an extended period of time in temperatures as high as 40° C or subjected to repeated slow freezing-and-thawing. It is expected that immunization programs can potentially benefit by integrating thin-film freeze-drying into vaccine preparations.
MeSH term(s)	Adjuvants, Immunologic/administration & dosage ; Adjuvants, Immunologic/radiation effects ; Aluminum Hydroxide/administration & dosage ; Aluminum Hydroxide/radiation effects ; Animals ; Female ; Freeze Drying ; Mice, Inbred BALB C ; Ovalbumin/administration & dosage ; Ovalbumin/immunology ; Ovalbumin/radiation effects ; Temperature ; Vaccine Potency ; Vaccines/administration & dosage ; Vaccines/immunology ; Vaccines/radiation effects
Chemical Substances	Adjuvants, Immunologic ; Vaccines ; Aluminum Hydroxide (5QB0T2IUN0) ; Ovalbumin (9006-59-1)
Language	English
Publishing date	2017-04-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2016.1259042
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Article ; Online: Amorphous or Crystalline? A Comparison of Particle Engineering Methods and Selection.

Thakkar, Sachin G / Fathe, Kristin / Smyth, Hugh D C

Current pharmaceutical design

2015 Volume 21, Issue 40, Page(s) 5789–5801

Abstract: This review is intended to provide a critical account of the current goals and technologies of particle engineering regarding the production of crystalline and amorphous particles. The technologies discussed here cover traditional crystallization ... ...

Abstract	This review is intended to provide a critical account of the current goals and technologies of particle engineering regarding the production of crystalline and amorphous particles. The technologies discussed here cover traditional crystallization technologies, supercritical fluid technologies, spray drying, controlled solvent crystallization, and sonocrystallization. Also recent advancements in particle engineering including spray freezing into liquid, thin-film freeze-drying, PRINT technology are presented. The paper also examines the merits and limitations of these technologies with respect to their methods of characterization. Additionally a section discussing the utility of creating amorphous and crystalline formulation approaches in regards to bioavailability and utility in formulation is presented.
MeSH term(s)	Biological Availability ; Chemistry, Pharmaceutical ; Crystallization ; Freeze Drying ; Humans ; Particle Size ; Pharmaceutical Preparations/administration & dosage ; Solubility ; Technology, Pharmaceutical/methods
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2015-08-25
Publishing country	United Arab Emirates
Document type	Journal Article ; Review
ZDB-ID	1304236-1
ISSN	1873-4286 ; 1381-6128
ISSN (online)	1873-4286
ISSN	1381-6128
DOI	10.2174/1381612821666151008150457
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Zs.A 4714: Show issues

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Article ; Online: Immunogenicity of Antigen Adjuvanted with AS04 and Its Deposition in the Upper Respiratory Tract after Intranasal Administration.

Xu, Haiyue / Alzhrani, Riyad F / Warnken, Zachary N / Thakkar, Sachin G / Zeng, Mingtao / Smyth, Hugh D C / Williams, Robert O / Cui, Zhengrong

Molecular pharmaceutics

2020 Volume 17, Issue 9, Page(s) 3259–3269

Abstract: Adjuvant system 04 (AS04) is in injectable human vaccines. AS04 contains two known adjuvants, 3- ...

Abstract	Adjuvant system 04 (AS04) is in injectable human vaccines. AS04 contains two known adjuvants, 3-
MeSH term(s)	Adjuvants, Immunologic/pharmacology ; Administration, Intranasal/methods ; Aluminum Hydroxide/immunology ; Animals ; Antibody Formation/immunology ; Antigens/immunology ; Cytokines/immunology ; Female ; Humans ; Immunity/immunology ; Immunity, Mucosal/immunology ; Immunization/methods ; Immunogenicity, Vaccine/immunology ; Lipid A/analogs & derivatives ; Lipid A/immunology ; Mice ; Mice, Inbred BALB C ; Ovalbumin/immunology ; Respiratory System/immunology ; Vaccination/methods ; Vaccines/immunology
Chemical Substances	ASO4 mixture ; Adjuvants, Immunologic ; Antigens ; Cytokines ; Lipid A ; Vaccines ; Aluminum Hydroxide (5QB0T2IUN0) ; Ovalbumin (9006-59-1) ; monophosphoryl lipid A (MWC0ET1L2P)
Language	English
Publishing date	2020-08-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2138405-8
ISSN	1543-8392 ; 1543-8384
ISSN (online)	1543-8392
ISSN	1543-8384
DOI	10.1021/acs.molpharmaceut.0c00372
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Article ; Online: Nasal aluminum (oxy)hydroxide enables adsorbed antigens to induce specific systemic and mucosal immune responses.

Xu, Haiyue / Ruwona, Tinashe B / Thakkar, Sachin G / Chen, Yanping / Zeng, Mingtao / Cui, Zhengrong

Human vaccines & immunotherapeutics

2017 Volume 13, Issue 11, Page(s) 2688–2694

Abstract: Some insoluble aluminum salts are commonly used in injectable vaccines as adjuvants to accelerate, prolong, or enhance the antigen-specific immune responses. Data from previous studies testing the nasal mucosal vaccine adjuvant activity of aluminum salts ...

Abstract	Some insoluble aluminum salts are commonly used in injectable vaccines as adjuvants to accelerate, prolong, or enhance the antigen-specific immune responses. Data from previous studies testing the nasal mucosal vaccine adjuvant activity of aluminum salts are conflicting. The present study is designed to further assess the feasibility of using aluminum salts in injectable vaccines as nasal mucosal vaccine adjuvants. Using Alhydrogel®, the international scientific standard of aluminum (oxy)hydroxide gels, and ovalbumin or 3 × M2e-HA2, a synthetic influenza virus fusion protein, as antigens, we showed in a mouse model that when dosed intranasally Alhydrogel® enables antigens adsorbed on it to induce stronger antigen-specific immune responses in both serum samples (e.g., specific IgG) and nasal and lung mucosal secretions (i.e., specific IgA) in all immunized mice, as compared with nasal immunization with the antigens alone. Rerouting insoluble aluminum salts in injectable vaccines may represent a viable approach for (nasal) mucosal vaccine adjuvant discovery.
MeSH term(s)	Adjuvants, Immunologic/administration & dosage ; Adjuvants, Immunologic/chemistry ; Administration, Intranasal ; Adsorption ; Aluminum Hydroxide/administration & dosage ; Aluminum Hydroxide/chemistry ; Aluminum Hydroxide/immunology ; Animals ; Antibody Formation/immunology ; Antigens, Viral/chemistry ; Antigens, Viral/genetics ; Antigens, Viral/immunology ; Female ; Immunity, Mucosal ; Immunoglobulin A/analysis ; Immunoglobulin A/biosynthesis ; Immunoglobulin A/immunology ; Immunoglobulin G/biosynthesis ; Immunoglobulin G/blood ; Immunoglobulin G/immunology ; Mice ; Mice, Inbred BALB C ; Nasal Mucosa/immunology ; Vaccination ; Viral Fusion Proteins/administration & dosage ; Viral Fusion Proteins/immunology
Chemical Substances	Adjuvants, Immunologic ; Antigens, Viral ; Immunoglobulin A ; Immunoglobulin G ; Viral Fusion Proteins ; Aluminum Hydroxide (5QB0T2IUN0)
Language	English
Publishing date	2017-09-21
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.1080/21645515.2017.1365995
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Article ; Online: Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial.

Hegde, Meenakshi / Navai, Shoba / DeRenzo, Christopher / Joseph, Sujith K / Sanber, Khaled / Wu, Mengfen / Gad, Ahmed Z / Janeway, Katherine A / Campbell, Matthew / Mullikin, Dolores / Nawas, Zeid / Robertson, Catherine / Mathew, Pretty R / Zhang, Huimin / Mehta, Birju / Bhat, Raksha R / Major, Angela / Shree, Ankita / Gerken, Claudia /

Kalra, Mamta / Chakraborty, Rikhia / Thakkar, Sachin G / Dakhova, Olga / Salsman, Vita S / Grilley, Bambi / Lapteva, Natalia / Gee, Adrian / Dotti, Gianpietro / Bao, Riyue / Salem, Ahmed Hamed / Wang, Tao / Brenner, Malcolm K / Heslop, Helen E / Wels, Winfried S / Hicks, M John / Gottschalk, Stephen / Ahmed, Nabil

Nature cancer

2024

Abstract: In this prospective, interventional phase 1 study for individuals with advanced sarcoma, we infused autologous HER2-specific chimeric antigen receptor T cells (HER2 CAR T cells) after lymphodepletion with fludarabine (Flu) ± cyclophosphamide (Cy): 1 × ... ...

Abstract	In this prospective, interventional phase 1 study for individuals with advanced sarcoma, we infused autologous HER2-specific chimeric antigen receptor T cells (HER2 CAR T cells) after lymphodepletion with fludarabine (Flu) ± cyclophosphamide (Cy): 1 × 10
Language	English
Publishing date	2024-04-24
Publishing country	England
Document type	Journal Article
ISSN	2662-1347
ISSN (online)	2662-1347
DOI	10.1038/s43018-024-00749-6
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Article: Interleukin-15-armored GPC3-CAR T cells for patients with solid cancers.

Steffin, David / Ghatwai, Nisha / Montalbano, Antonino / Rathi, Purva / Courtney, Amy N / Arnett, Azlann B / Fleurence, Julien / Sweidan, Ramy / Wang, Thao / Zhang, Huimin / Masand, Prakash / Maris, John M / Martinez, Daniel / Pogoriler, Jennifer / Varadarajan, Navin / Thakkar, Sachin G / Lyon, Deborah / Lapteva, Natasha / Mei, Zhuyong /

Patel, Kalyani / Lopez-Terrada, Dolores / Ramos, Carlos / Lulla, Premal / Armaghany, Tannaz / Grilley, Bambi J / Dotti, Gianpietro / Metelitsa, Leonid S / Heslop, Helen E / Brenner, Malcolm K / Sumazin, Pavel / Heczey, Andras

Research square

2024

Abstract: Interleukin-15 (IL15) promotes the survival of T lymphocytes and enhances the antitumor properties of CAR T cells in preclinical models of solid neoplasms in which CAR T cells have limited ... ...

Abstract	Interleukin-15 (IL15) promotes the survival of T lymphocytes and enhances the antitumor properties of CAR T cells in preclinical models of solid neoplasms in which CAR T cells have limited efficacy
Language	English
Publishing date	2024-04-03
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-4103623/v1
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