Abstract:
Human challenge trials (HCT) or controlled human infection model (CHIM), which involve purposeful or intentional exposure of infectious microorganisms to healthy human volunteers, have a long history in medicine and have contributed significantly to our understanding of the science behind vaccine development.
Human challenge studies are unique in their ability to investigate and understand the onset and progression of disease in a secure and carefully monitored environment, observe and analyse complex interactions between bacteria/ viruses and the human immune system, and to identify strategies to disrupt and prevent infections.
Nevertheless, such research may seem to be in conflict with the guiding principle in medicine to ‘do no harm’. But, it's important to realize that administering injections intravenously or using a biopsy needle might also be seen as "causing harm”.
Although HCT are not a required element of every vaccine development program, there are reasons why a vaccine developer may want to conduct a “challenge-protection” study in humans, which might normally be conducted in animals.
Audience Take Away:
- An understanding of what is HCT, some examples, benefits and challenges
Biography:
Dr. Sudhakar Bangera did his MBBS from KIMS, Bangalore; MD (Pharmacology) from KMC Mangalore; and MMedSc (Clinical Trials Methodology) from the University of Hong Kong. Dr. Bangera is also trained on India Vaccinology Course with CMC Vellore, and funded by Bill & Melinda Gates Foundation for International Vaccinology at IVI, Seoul. He has extensive work experience of 30 years in healthcare, of which 26 years are in global and local CRO, ARO, SMO, Medical Imaging, Clinical Bioavailability and Bioequivalence, Public Health, Government agency, Pharmaceutical and Vaccine manufacturing companies in various capacities as COO, Country Manager, Vice-President, Director, Project Manager in national and international organisations. Dr. Bangera has worked on several hundred BA-BE and phase 1 to 4 clinical trials for new pharmaceuticals, vaccines, medical devices, biologicals and cosmetics, He has been a speaker on several topics in the clinical research domain in more than 150 invited talks. He was responsible for phase 1 clinical trials of Chikungunya, Zika and other vaccines in later phases. Currently, Dr. Bangera is managing his consulting firm, AILEEN Clinical Research Services as Managing Partner at Hyderabad India, and a medical technology translation advisor to students, faculty and healthcare startup entrepreneurs at several bioincubators on clinical development and regulatory requirements. Dr. Bangera is an author of two books – Medical Device – Concept to Commercialisation: India Perspective, and The CRA.
