PATRICIA
PATRICIA showed that three doses of a vaccine against the two human papillomavirus types behind most cervical cancers prevented almost all of the type-specific high-grade cervical precancers in young women who were free of those types when vaccinated, which carried Cervarix to approval in Europe and the United States.
Overview
PATRICIA (PApilloma TRIal against Cancer In young Adults; Cervarix product information study HPV-008; NCT00122681) was a multinational, double-blind, randomised, controlled phase 3 trial of the HPV-16/18 AS04-adjuvanted vaccine in women aged 15 to 25 years. Women received the HPV vaccine or a hepatitis A vaccine control at months 0, 1 and 6.
The primary endpoint was vaccine efficacy against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV-16 or HPV-18 in the according-to-protocol cohort for efficacy (women seronegative at baseline and DNA negative at baseline and month 6 for the corresponding type; vaccine 8,093, control 8,069). In the Lancet 2009 final event-driven analysis, after a mean follow-up of 34.9 months from the third dose, vaccine efficacy was 92.9 percent (96.1 percent CI 79.9 to 98.3) in the primary analysis and 98.1 percent (88.4 to 100) when probable causality to HPV type was assigned in lesions infected with several oncogenic types. Efficacy against CIN2+ irrespective of HPV type was 30.4 percent in the total vaccinated cohort and 70.2 percent in women with no evidence of oncogenic HPV infection at baseline, and cross-protection against CIN2+ associated with HPV-31, HPV-33 and HPV-45 was seen.
The Cervarix product information names the study HPV-008 and quotes the same 92.9 percent event-triggered figure. ClinicalTrials.gov registers the trial with condition papillomavirus infection rather than a cancer, which is why the automated pass never attached it to the vaccine record.
- 92.9 out of 100 people reached this endpoint with HPV-16/18 AS04-adjuvanted vaccine.
- Hepatitis A vaccine control: Reference arm; the abstract reports efficacy, not a control-arm rate.
- 70.2 out of 100 people reached this endpoint with HPV-16/18 AS04-adjuvanted vaccine.
- Hepatitis A vaccine control: number not reported here.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Women aged 15 to 25 years: HPV-16/18 AS04-adjuvanted vaccine versus hepatitis A vaccine control at months 0, 1 and 6, for prevention of cervical precancer associated with HPV-16 or HPV-18. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
18,644 randomised.
96.1% confidence interval 79.9 to 98.3; efficacy is relative to the control arm · Reference arm; the abstract reports efficacy, not a control-arm rate
Source96.1% confidence interval 54.7 to 80.9
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (according-to-protocol cohort for efficacy, primary analysis)primary | HPV-16/18 AS04-adjuvanted vaccine | 8,093 | 92.9% | - | - | link |
| Hepatitis A vaccine control | 8,069 | Reference arm; the abstract reports efficacy, not a control-arm rate | ||||
| Vaccine efficacy against CIN2+ irrespective of HPV type (total vaccinated cohort, no evidence of oncogenic HPV at baseline) | HPV-16/18 AS04-adjuvanted vaccine | 5,822 | 70.2% | - | - | link |
| Hepatitis A vaccine control | 5,819 | - |
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