Human infection studies: Key considerations for challenge agent development and production

Balasingam, Shobana; Meillon, Sarah; Chui, Cecilia; Mann, Alex; La, Carine; Weller, Charlotte; King, Deborah; Smith, Emma

doi:10.12688/wellcomeopenres.17869.1

Cited by 7 publications

(4 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Challenge organisms meet the U.S. FDA definitions [11]. Other parts of the world (including the UK) may not consider challenge agents to be biological products or drugs, and accordingly do not regulate them in the same way [20]. We focus on the U.S. FDA definition to argue that expected symptoms should be reported as AEs.…”

Section: What Meets the Definition Of A Human Infection Study?mentioning

confidence: 99%

Standardizing Controlled Human Infection Study Reporting Discussion and Guidelines

Adams-Phipps¹,

Toomey²

2023

Preprint

View full text Add to dashboard Cite

Controlled Human Infection Studies (CHIS) involve intentional, controlled exposures of human volunteers to infectious disease organisms. Following our experience conducting a systematic review of CHIS published between 1980 and 2021, we identified several issues around the terminology used to describe and identify CHIS, the definitions of CHIS and challenge phases within them, and the definition and reporting of AEs experienced by CHIS volunteers. The present work discusses these issues further, and proposes guidelines to better standardize CHIS definitions and AE reporting across the field.

show abstract

Section: What Meets the Definition Of A Human Infection Study?mentioning

confidence: 99%

Standardizing Controlled Human Infection Study Reporting Discussion and Guidelines

Adams-Phipps¹,

Toomey²

2023

Preprint

View full text Add to dashboard Cite

show abstract

“…On day 14 post-CHMI, both volunteers, with parasites and symptoms, were admitted to the Oxford clinical trials unit, and parasitized erythrocytes collected via a 250 mL blood sample ( 23 ). The challenge agent is produced stringently and safely ( 55 , 56 ) following guidance on the minimum requirements for human challenge agents manufactured outside a GMP facility, and is based on principles that can be applied across high-, middle- and low-income countries ( 55 , 57 ). Neither IRB in the UK or Thailand had question the manufacture of the challenge agent outside of a strict GMP setting.…”

Section: Oxford Uk: How To Make the Parasite Bank And Test It For Hum...mentioning

confidence: 99%

The challenges of Plasmodium vivax human malaria infection models for vaccine development

Roobsoong

Yadava²,

Draper³

et al. 2023

Front. Immunol.

View full text Add to dashboard Cite

Controlled Human Malaria Infection models (CHMI) have been critical to advancing new vaccines for malaria. Stringent and safe preparation of a challenge agent is key to the success of any CHMI. Difficulty producing the Plasmodium vivax parasite in vitro has limited production of qualified parasites for CHMI as well as the functional assays required to screen and down-select candidate vaccines for this globally distributed parasite. This and other challenges to P. vivax CHMI (PvCHMI), including scientific, logistical, and ethical obstacles, are common to P. vivax research conducted in both non-endemic and endemic countries, with additional hurdles unique to each. The challenges of using CHMI for P. vivax vaccine development and evaluation, lessons learned from previous and ongoing clinical trials, and the way forward to effectively perform PvCHMI to support vaccine development, are discussed.

show abstract

“…These trials are used to assess the effectiveness of vaccines against a wide variety of at least 30 different pathogens. More than 15,000 individuals have participated in these trials, which have covered typhoid, cholera, yellow fever, influenza, SARS-CoV-2, and many other diseases [84,85].…”

Section: Human Challenge Trialsmentioning

confidence: 99%

Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses

He,

Zhang,

Huan

et al. 2023

Vaccines

View full text Add to dashboard Cite

Influenza vaccines faced significant challenges in achieving sufficient protective efficacy and production efficiency in the past. In recent decades, novel influenza vaccines, characterized by efficient and scalable production, advanced platforms, and new adjuvant technologies, have overcome some of these weaknesses and have been widely licensed. Furthermore, researchers are actively pursuing the development of next-generation and universal influenza vaccines to provide comprehensive protection against potential pandemic subtypes or strains. However, new challenges have emerged as these novel vaccines undergo evaluation and authorization. In this review, we primarily outline the critical challenges and advancements in research and development (R&D) and highlight the improvements in regulatory responses for influenza vaccines.

show abstract

Human infection studies: Key considerations for challenge agent development and production

Cited by 7 publications

References 13 publications

Standardizing Controlled Human Infection Study Reporting Discussion and Guidelines

Standardizing Controlled Human Infection Study Reporting Discussion and Guidelines

The challenges of Plasmodium vivax human malaria infection models for vaccine development

Novel Influenza Vaccines: From Research and Development (R&D) Challenges to Regulatory Responses

Contact Info

Product

Resources

About