Vaccine trial
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A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.[1]
A vaccine candidate drug is first identified through preclinical evaluations that could involve high throughput screening and selecting the proper antigen to invoke an immune response.[citation needed]
Some vaccine trials may take months or years to complete, depending on the time required for the subjects to react to the vaccine and develop the required antibodies.
Preclinical stage
Preclinical development stages are necessary to determine the immunogenicity potential and safety profile for a vaccine candidate.[2]
This is also the stage in which the drug candidate may be first tested in laboratory animals prior to moving to the
Recent scientific advances have helped to use
Phase I
The Phase I study consists of introducing the vaccine candidate to assess its safety in healthy people. A vaccine Phase I trial involves normal healthy subjects, each tested with either the candidate vaccine or a "
After the administration of the vaccine or placebo, the researchers collect data on
One typical version of Phase I studies in vaccines involves an escalation study, which is used in mainly medicinal research trials. The drug is introduced into a small cohort of healthy volunteers. Vaccine escalation studies aim to minimize chances of serious adverse effects (SAE) by slowly increasing the drug dosage or frequency.
Phase II
The transition to Phase II relies on the immunogenic and toxicity results from Phase I in a small cohort of healthy volunteers.[6] Phase II will consist of more healthy volunteers in the vaccine target population (~ hundreds of people) to determine reactions in a more diverse set of humans and test different schedules.
Phase III
Similarly. Phase III trials continue to monitor toxicity, immunogenicity, and SAEs on a much larger scale.[6] The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval and then general production. In the United States, the Food and Drug Administration (FDA) is responsible for approving vaccines.[7]
Phase IV
References
- MR 2572061.[page needed]
- ^ "How are Vaccines Made? Vaccine Development, Testing, and Regulation". History of Vaccines. The College of Physicians of Philadelphia. Archived from the original on 10 December 2022. Retrieved 12 December 2022.
- ^ a b Neurovirulence Test of Types 1, 2 or 3 Live attenuated Poliomyelitis vaccines (Oral) in Transgenic Mice susceptible to Poliovirus. Standard Operating Procedure. World Health Organization. 2015.
- ^ "Vaccine product approval process". US Food and Drug Administration. 30 January 2018. Retrieved 25 September 2020.
- ^ PMID 15811654.
- ^ ISBN 978-0-12-107258-2.[page needed]
- ^ Research, Center for Biologics Evaluation and. "Biologics License Applications (BLA) Process (Biologics) – Vaccine Product Approval Process". www.fda.gov. Retrieved 15 November 2015.
- PMID 15505253.
- S2CID 37579770.
- PMID 11806796.
- ^ Penina Haber, MPH; Frank DeStefano, MD, MPH; Fredrick J. Angulo, DVM, PhD; et al, Guillain-Barré Syndrome Following Influenza Vaccination, 2004, https://jamanetwork.com/journals/jama/fullarticle/199859Kramarz, Piotr, Eric K. France, Frank Destefano, Steven B. Black, Henry Shinefield, Joel I. Ward, Emily J. Chang et al. "Population-based study of rotavirus vaccination and intussusception." The Pediatric infectious disease journal 20, no. 4 (2001): 410-416.] The rotavirus vaccine originated in 1998 and was withdrawn in 1999.
External links
- Vaccine Research Center Information regarding preventative vaccine research studies