Table 3.

Cervical HPV virology

Cohort 1Cohort 2Cohort 3Cohort 4
Open-labelOpen-labelRandomized, double-blindedOpen-label
CategoryTimeValueGTL001 100 μg solution + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + placeboPlacebo injection + imiquimodGTL001 600 μg powder + imiquimod
Change in HPV16viral load fromNo. positive at baseline5411556
baselineWeek 10Mean ± SD108.2 ± 167.1−370.5 ± 998.3−775.7 ± 2808.611.7 ± 31.1855 ± 2406.1−562.3 ± 1252.1
Min, max−11, 374−1850, 340−9217, 669−7, 67−612, 5139−3114, 10
Week 26Mean ± SD647.4 ± 1148.2−784.7 ± 1568.2−41.9 ± 2886.2−1.7 ± 4.62042.6 ± 4984.1−322.5 ± 872.4
Min, max−5, 2675−3137, 2−6401, 6499−6, 6−637, 10946−2091, 234
Last obsMean ± SD1710 ± 4190.4−824.7 ± 1636.9−959.0 ± 2956.532.8 ± 77.1185.4 ± 677.8−355.2 ± 789.6
Min, max−925, 9159−3280, −3−9411, 143−6, 171−259, 1364−1764, 88
Time to last obsMedian (mo)22.924.315.817.617.011.3
Change in HPV18 viral load from baselineNo. positive at baseline013223
Week 10Mean ± SD−20.0−91.1 ± 154.1−2.3 ± 3.120.0 ± 52.376.0 ± 188.7
Min, max−269, 0−4, 0−17, 57−62, 291
Week 26Mean ± SD−20.0−91.1 ± 154.1−2.1 ± 2.7−6.0 ± 42.4−70.3 ± 72.1
Min, max−269, 0−4, 0−36, 24−145, −1
Last obsMean ± SD−20.0−90.8 ± 154.4−2.6 ± 3.5−63.0 ± 38.2−70.7 ± 72.1
Min, max−269, 1−5, 0−90, −36−145, −1
Median time to last obs (mo)Median (mo)18.714.810.420.811.1
HPV16/18Baselinen/N (%)0/5 (100.0)0/5 (0.0)0/14 (100.0)0/7 (0.0)0/7 (0.0)0/9 (0.0)
clearanceaWeek 10n/N (%)1/5 (20.0)1/5 (20.0)4/14 (28.6)1/7 (14.3)0/7 (0.0)3/9 (33.3)
Week 26n/N (%)1/5 (20.0)2/5 (40.0)4/14 (28.6)1/7 (14.3)3/7 (42.9)4/9 (44.4)
Last obsn/N (%)2/5 (40.0)5/5 (100.0)9/14 (64.3)2/7 (28.6)3/7 (42.9)5/9 (55.5)
Sustained HPV16/18 clearancebn/N (%)2/3 (66.7)2/3 (66.7)5/6 (83.3)0/2 (0.0)1/3 (33.3)3/4 (75.0)
  • NOTE: HPV16 and HPV18 were detected by qPCR. Values are for the safety population.

  • Abbreviation: obs, observation.

  • aPost hoc analysis in which clearance was defined as an HPV-negative qPCR result at the indicated time point.

  • bPost hoc analysis in which sustained clearance was defined as an HPV-negative qPCR result followed by maintenance of HPV-negative results until the last date of follow-up included in this analysis (December 31, 2012).