Integrating Safety and Efficacy Evaluation Throughout Vaccine Research and Development

Curlin, George T.; Landry, Sarah; Bernstein, Jessica; Gorman, Richard L.; Mulach, Barbara; Hackett, Charles J.; Foster, Stephanie L.; Miers, Sarah; Strickler-Dinglasan, Patricia

doi:10.1542/peds.2010-1722c

Cited by 13 publications

(4 citation statements)

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“…After evaluating the vaccine potential of each antigen in animal models, the three most promising vaccine candidates [Abundant Larval transcript (r Bm ALT-2) [6], Tetraspanin Large extracellular loop (r Bm TSP LEL) [7] and small Heat Shock Protein 12.6 (r Bm HSP12.6) [2] were down selected to prepare a single multivalent fusion protein vaccine, r Bm HAT [ Bm Hsp12.6+ Bm ALT-2+ Bm TSPLEL] [8]. One of our recent studies showed that Bm HSP12.6 can bind to human IL-10 receptor-α (hIL-10R) and may exhibit IL-10 like function [2], which is potentially not advantageous for developing Bm HSP12.6 as a vaccine [9,10]. Subsequently, we analyzed the Bm HSP12.6 sequence and identified the presence of hIL-10R binding sequences within Val 5 to Glu 42 in the N-terminus region of Bm HSP12.6 [2].…”

Section: Introductionmentioning

confidence: 99%

Evaluating the efficacy of rBmHATαc as a multivalent vaccine against lymphatic filariasis in experimental animals and optimizing the adjuvant formulation

Dakshinamoorthy

Kalyanasundaram

2013

Vaccine

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Developing an effective vaccine against lymphatic filariasis will complement the WHO's effort to eradicate the infection from endemic areas. Currently 83 different countries are endemic for this infection and over 1 billion people are at risk. An effective vaccine coupled with mass drug administration will reduce the morbidity and social stigma associated with this gruesome disease. Several potential vaccine candidates that can confer partial protection in experimental animals have been reported from different laboratories. However, no licensed vaccines are currently available for this disease. Among the several vaccine antigens identified from our laboratory, three most promising antigens; rBmHSPαc (α crystalline domain and c-terminal extension of Heat Shock Protein 12.6), rBmALT-2 (Abundant larval transcript) and rBmTSP LEL (Tetraspanin large extracellular loop) was further developed as a recombinant fusion protein vaccine (rBmHATαc). In a mouse model this fusion protein vaccine gave close to 68% protection following a challenge infection. To improve the vaccine efficiency of rBmHATαc, in this study we evaluated various preparations of alum (AL007, AL019, Alhydrogel and Imject® Alum) as adjuvants. Our results show that mice immunized with rBmHATαc formulated in AL007 (alum from IDRI) and/or AL019 (alum plus TLR-4 agonist from IDRI) gave the highest IgG antibody titer compared to other groups. Subsequent in vivo challenge experiments confirmed that >95% protection can be achieved when AL007 or AL019 was used as the adjuvant. However, when Imject® Alum or alhydrogel was used as the adjuvant only 76% and 72% protection respectively could be achieved. These results show that AL007 or AL019 (IDRI) is an excellent choice of adjuvant for the rBmHATαc vaccine against B. malayi L3 in mice.

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Section: Introductionmentioning

confidence: 99%

Evaluating the efficacy of rBmHATαc as a multivalent vaccine against lymphatic filariasis in experimental animals and optimizing the adjuvant formulation

Dakshinamoorthy

Kalyanasundaram

2013

Vaccine

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“…The primary goal of such monitoring is to identify and assess adverse events linked to drugs, medical devices, vaccines, and other health products regulated by health authorities [ 90 ]. As an integral part of the evaluation process for vaccine safety and efficacy, monitoring adverse reactions plays a pivotal role in leveraging this information to protect public health [ 27 , 158 , 159 ].…”

Section: Vaccines and Adverse Reactions After Immunizationmentioning

confidence: 99%

Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

Hodel,

Fiuza,

Conceição

et al. 2024

Pharmaceuticals

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Pharmacovigilance plays a central role in safeguarding public health by continuously monitoring the safety of vaccines, being critical in a climate of vaccine hesitancy, where public trust is paramount. Pharmacovigilance strategies employed to gather information on adverse events following immunization (AEFIs) include pre-registration data, media reports, clinical trials, and societal reporting. Early detection of AEFIs during clinical trials is crucial for thorough safety analysis and preventing serious reactions once vaccines are deployed. This review highlights the importance of societal reporting, encompassing contributions from community members, healthcare workers, and pharmaceutical companies. Technological advancements such as quick response (QR) codes can facilitate prompt AEFI reporting. While vaccines are demonstrably safe, the possibility of adverse events necessitates continuous post-marketing surveillance. However, underreporting remains a challenge, underscoring the critical role of public engagement in pharmacovigilance. This narrative review comprehensively examines and synthesizes key aspects of virus vaccine pharmacovigilance, with special considerations for specific population groups. We explore applicable legislation, the spectrum of AEFIs associated with major vaccines, and the unique challenges and perspectives surrounding pharmacovigilance in this domain.

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“…The first steps are exploratory in nature. The exploratory stage involves basic laboratory research and often lasts 2-4 years [12]. The research community of academic, government, and industry scientists identifies natural or synthetic antigens that may have potential in preventing or treating a disease.…”

Section: Exploratory Stagementioning

confidence: 99%

The Regulatory Evaluation of Vaccines for Human Use

Baylor¹

2021

Methods in Molecular Biology

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A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to prevent, ameliorate, or treat a disease or infection. A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), mRNA, living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive testing and characterization. Special expertise and procedures are required for the manufacture, control, and regulation of vaccines. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and national regulatory authorities. In this chapter, an overview of the regulatory evaluation and testing requirements for vaccines is presented.

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Integrating Safety and Efficacy Evaluation Throughout Vaccine Research and Development

Cited by 13 publications

References 4 publications

Evaluating the efficacy of rBmHATαc as a multivalent vaccine against lymphatic filariasis in experimental animals and optimizing the adjuvant formulation

Evaluating the efficacy of rBmHATαc as a multivalent vaccine against lymphatic filariasis in experimental animals and optimizing the adjuvant formulation

Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

The Regulatory Evaluation of Vaccines for Human Use

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