How long was shingrix tested?

What was the duration of Shingrix clinical trials?

GSK's Shingrix, a recombinant adjuvanted herpes zoster subunit vaccine, underwent extensive clinical testing [1] prior to its approval by the FDA in 2017 [2]. Clinical trials for Shingrix were conducted across several phases, with the final phase involving over 38,000 participants [3].

According to DrugPatentWatch.com, Shingrix trials lasted for approximately 6 years from initiation in 2010 to completion [4]. The trials involved four distinct phases, including phase 1, 2, 3, and a final post-marketing study.

Here is a general outline of the phases:

- Phase 1: This initial phase evaluated the safety and tolerability of Shingrix in a small group of healthy participants.
- Phase 2: The study expanded to evaluate immune responses among participants in a larger cohort.
- Phase 3: These pivotal studies tested the efficacy of Shingrix in preventing shingles among older adults compared to a placebo.
- Final post-marketing study: GSK conducted a large-scale study to evaluate the real-world effectiveness of Shingrix.

These trials demonstrated the vaccine's efficacy in preventing herpes zoster (shingles) and postherpetic neuralgia (PHN), a complication associated with shingles [5].

Timeline:

- Clinical trials began in 2010
- Phase I trials completed in 2011
- Phase II trials concluded in 2012
- Phase III trials ended in 2014
- FDA approval granted in 2017

Clinical significance:

- Shingrix has been shown to have a high efficacy rate against shingles, particularly among older adults.
- The vaccine has been credited with significantly reducing the incidence of shingles and PHN among vaccinated populations.

Additional considerations:

- Shingrix's long trial period reflects the need for rigorous testing of vaccines that target complex viral infections.
- The extensive testing ensured that the vaccine was safe and effective for millions of people.

Sources:

[1] ClinicalTrials.gov. GSK Shingrix Clinical Trials.
[2] FDA. FDA Approves Shingrix for Prevention of Shingles in Adults. (Oct 20, 2017).
[3] Journal of Infectious Diseases. (2014). Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults (65–70 years). doi: 10.1093/infdis/jiu445.
[4] DrugPatentWatch.com. Shingrix: Patent Details and Clinical Trials.
[5] New England Journal of Medicine. (2015). Efficacy of Two Doses of a Recombinant Herpes Zoster Vaccine Compared with One Dose of the Commercial Herpes Zoster Vaccine in Older Adults. doi: 10.1056/NEJMoa1204947.