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EFFECT OF HPV VACCINE ON PREEXISTING HPV INFECTION

clearance were 27.3% vs 27.5% for HPV-16, 46.1% vs 44.7% for HPV-18, and 33.4% vs 31.6% for HPV-16/18 among participants who received the HPV vaccine and the control vaccine, respectively. At the 12-month visit, rates of clearance among participants in the HPV group and the control group, re- spectively, were 43.9% vs 45.9% for HPV-16, 59.3% vs 60.7% for HPV-18, and 48.8% vs 49.8% for HPV-16/18. There was no evidence that HPV vac- cination significantly altered rates of vi- ral clearance; VEVC estimates overall ranged from −0.2% to 2.5% at the 6-month visit and from −3.7% to −2.0% at the 12-month visit. For HPV-16/18 in-

fections, the VEVC estimates were 2.5% (95% CI, −9.8% to 13.5%) at the 6-month visit and −2.0% (95% CI, −24.3% to 16.3%) at the 12-month visit. No sig- nificant evidence of a vaccine therapeu- tic effect was observed in analyses re- stricted to women who received all doses of vaccine or those with evidence of single HPV infections at entry (Table 2). We observed no evidence of vac- cine effects when we stratified the analy- sis on selected study entry character- istics reflective of disease extent, including HPV-16/18 antibody re- sults, cytologic results, and HPV viral load (TABLE 3). Similarly, no evidence of vaccine effects was observed in analy-

ses stratified by other study entry para- meters thought to potentially influ- ence clearance rates and efficacy of the vaccine, including time since sexual initiation, oral contraceptive use, ciga- rette smoking, and concomitant infec- tion with C trachomatis or N gonor- rhoeae (Table 3).

TABLE 4 presents results from analy- ses that evaluated rates of viral clear- ance and VEVC for HPV categories other than HPV-16 and HPV-18. Rates of viral clearance at the 6-month visit for these other HPV categories were higher than for HPV-16 in particular, ranging from 44.6% to 61.1% in the control group; clearance rates at the 12-

Table 3. Viral Clearance and Vaccine Efficacy for Viral Clearance for HPV-16/18 by Study Group at 6 Months and 12 Months of Follow-up, Stratified by Selected Factorsa

6-Month Follow-up

12-Month Follow-up

HPV Vaccine Group

Control Group

Vaccine Efficacy for Viral Clearance, % (95% CI)

HPV Vaccine Group

Control Group

6/31 (21.4) 20/74 (26.9) 56/143 (39.2)

15/39 (35.1) 18/79 (22.7) 62/180 (34.7)

−21.1 (−64.5 to 10.8) 5.4 (−13.8 to 21.4) 6.9 (−10.5 to 21.6)

9/21 (47.4) 22/49 (43.6) 55/107 (51.4)

14/28 (46.2) 26/57 (45.5) 70/135 (52.3)

0/3 53/152 (35.0) 29/93 (31.8)

0/1 60/195 (30.6) 35/102 (34.0)

6.4 (−8.9 to 19.5) −3.3 (−26.5 to 15.6)

0 69/147 (46.8) 17/30 (57.3)

0/1 95/188 (50.3) 15/31 (48.4)

4/6 (66.7) 13/41 (31.7) 30/94 (32.0) 35/107 (32.8)

1/7 (14.3) 19/54 (34.0) 36/126 (28.6) 39/111 (34.6)

61.1 (−25.5 to 87.9) −3.4 (−37.4 to 22.2) 4.7 (−13.8 to 20.2) −2.7 (−24.9 to 15.5)

3/4 (75.0) 18/37 (48.6) 34/80 (42.3) 31/56 (56.5)

2/5 (40.0) 28/52 (53.0) 52/107 (48.5) 28/56 (50.0)

0 26/78 (35.1) 31/80 (38.3) 25/90 (27.8)

0/1 29/92 (30.2) 38/110 (35.0) 28/95 (29.0)

7.0 (−15.6 to 25.2) 5.0 (−18.9 to 24.2) −1.7 (−22.1 to 15.3)

0 26/52 (51.0) 33/61 (53.4) 27/64 (42.7)

0 30/65 (46.0) 43/82 (53.2) 37/73 (49.4)

0 31/101 (30.3) 51/147 (35.3)

0/1 34/118 (28.7) 61/179 (33.8)

2.3 (−16.5 to 18.1) 2.3 (−14.8 to 16.8)

0 34/69 (48.7) 52/108 (49.1)

0 45/89 (51.0) 65/131 (48.8)

0 69/204 (34.1) 13/44 (29.3)

0/1 78/250 (31.1) 17/47 (34.9)

4.4 −8.6

(−9.0 to 16.1) (−45.8 to 19.1)

0 78/151 (52.0) 8/26 (30.8)

0 90/184 (48.9) 20/36 (54.4)

4/6 (66.7) 59/180 (33.5) 19/62 (30.1)

1/6 (16.7) 73/223 (32.5) 21/69 (30.3)

60.0 1.5 −0.2

(−31.1 to 87.8) (−13.4 to 14.5) (−25.7 to 20.1)

3/4 (75.0) 66/127 (52.4) 17/46 (36.0)

1/4 (25.0) 84/160 (52.6) 25/56 (43.6)

Characteristics

Serologic findings at entry Unknown

Negative Positive

Cytologic findings at entry Unknown

Normal Abnormal

HC2 viral load at entry, relative light units Unknown

0-2.0 2.0-50

  • 50

Time since sexual initiation, mo Unknown

0-36 37-72

  • 73

Oral or injectable contraceptive use Unknown

No current use Current use

Smoking status Unknown

Not current smoker Current smoker

Chlamydia/gonorrhea status at entry Unknown

Negative Positive

No. Cleared/Total Infections (%)

b

No. Cleared/Total Infections (%)

b

Vaccine Efficacy for Viral Clearance, % (95% CI)

2.3 (−70.4 to 43.9) −3.4 (−46.2 to 26.9) −1.7 (−32.7 to 22.0)

−6.9 (−32.2 to 13.5)

    • 17.2

      (−41.9 to 51.7)

    • 58.3

      (−162.9 to 93.4)

−9.3 (−67.7 to 28.8) −12.1 (−46.4 to 14.2)

    • 13.1

      (−30.4 to 42.0)

    • 9.2

      (−30.3 to 36.7)

    • 0.6

      (−42.8 to 30.8)

−13.2 (−54.8 to 17.3)

−4.6 (−43.4 to 23.8)

    • 0.5

      (−28.2 to 22.8)

    • 6.2

      (−17.1 to 24.8)

−51.9 (−136.7 to 2.5)

66.7 (−99.5 to 94.4) −0.3 (−28.7 to 21.8) −13.5 (−56.4 to 17.7)

Abbreviations: CI, confidence interval; HC2, Hybrid Capture 2 test; HPV, human papillomavirus. aHPV-16/18 is defined as HPV-16 and/or HPV-18.

bPercentages calculated using generalized estimating equations method and may therefore vary

from crude percentages.

750 JAMA, August 15, 2007—Vol 298, No. 7 (Reprinted)

©2007 American Medical Association. All rights reserved.

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