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Gardasil

Clinical Pharmacology
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Clinical Pharmacology

Gardasil

The primary analyses of efficacy were conducted in the per-protocol efficacy (PPE) population, consisting of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naïve (PCR negative in cervicovaginal specimens and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7). Efficacy was measured starting after the Month 7 visit.

Overall, 73% of subjects were naïve (i.e., PCR negative and seronegative for all 4 vaccine HPV types) to all 4 vaccine HPV types at enrollment.

A total of 27% of subjects had evidence of prior exposure to or ongoing infection with at least 1 of the 4 vaccine HPV types. Among these subjects, 74% had evidence of prior exposure to or ongoing infection with only 1 of the 4 vaccine HPV types and were naïve (PCR negative and seronegative) to the remaining 3 types.

In subjects who were naïve (PCR negative and seronegative) to all 4 vaccine HPV types, CIN, genital warts, VIN, and VaIN caused by any of the 4 vaccine HPV types were counted as endpoints.

Among subjects who were positive (PCR positive and/or seropositive) for a vaccine HPV type at Day 1, endpoints related to that type were not included in the analyses of prophylactic efficacy. Endpoints related to the remaining types for which the subject was naïve (PCR negative and seronegative) were counted.

For example, in subjects who were HPV 18 positive (PCR positive and/or seropositive) at Day 1, lesions caused by HPV 18 were not counted in the prophylactic efficacy evaluations. Lesions caused by HPV 6, 11, and 16 were included in the prophylactic efficacy evaluations. The same approach was used for the other types.

GARDASIL was efficacious in reducing the incidence of CIN (any grade including CIN 2/3); AIS; genital warts; VIN (any grade); and VaIN (any grade) related to vaccine HPV types in those who were PCR negative and seronegative at baseline (Table 1).

Table 1
Analysis of Efficacy of GARDASIL in the PPE* Population**

Population
GARDASIL
Placebo
% Efficacy (95% CI)
n
Number of cases
n
Number of cases
HPV 16- or 18-related CIN 2/3 or AIS
Protocol 005***
755
0
750
12
100.0 (65.1, 100.0)
Protocol 007
231
0
230
1
100.0 (-3734.9, 100.0)
FUTURE I
2200
0
2222
19
100.0 (78.5, 100.0)
FUTURE II
5301
0
5258
21
100.0† (80.9, 100.0)
Combined Protocols†
8487
0
8460
53
100.0† (92.9, 100.0)
HPV 6-, 11-, 16-, 18-related CIN (CIN 1, CIN 2/3) or AIS
Protocol 007
235
0
233
3
100.0 (-137.8, 100.0)
FUTURE I
2240
0
2258
37
100.0†(89.5, 100.0)
FUTURE II
5383
4
5370
43
90.7 (74.4, 97.6)
Combined Protocols
7858
4
7861
83
95.2 (87.2, 98.7)
HPV 6-, 11-, 16-, or 18-related Genital Warts
Protocol 007
235
0
233
3
100.0 (-139.5, 100.0)
FUTURE I
2261
0
2279
29
100.0 (86.4, 100.0)
FUTURE II
5401
1
5387
59
98.3 (90.2, 100.0)
Combined Protocols
7897
1
7899
91
98.9 (93.7, 100.0)
*The PPE population consisted of individuals who received all 3 vaccinations within 1 year of enrollment,did not have major deviations from the study protocol, and were naïve (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7).
**See Table 2 for analysis of vaccine impact in the general population.
***Evaluated only the HPV 16 L1 VLP vaccine component of GARDASIL.
†P-values were computed for pre-specified primary hypothesis tests. All p-values were <0.001, supporting the following conclusions: efficacy against HPV 16/18-related CIN 2/3 is >0% (FUTURE II); efficacy against HPV 16/18-related CIN 2/3 is >25% (Combined Protocols); and efficacy against HPV 6/11/16/18-related CIN is >20% (FUTURE I).
†Analyses of the combined trials were prospectively planned and included the use of similar study entry criteria.
n = Number of subjects with at least 1 follow-up visit after Month 7.
Note 1: Point estimates and confidence intervals are adjusted for person-time of follow-up.
Note 2: The first analysis in the table (i.e., HPV 16- or 18-related CIN 2/3, AIS or worse) was the primary endpoint of the vaccine development plan.
Note 3: FUTURE I refers to Protocol 013; FUTURE II refers to Protocol 015.
Brand Name: Gardasil
Generic Name: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
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