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Outcomes of the FUTURE I and FUTURE II HPV Vaccine Trials
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Analysis of Outcomes as Defined by Trialists
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FUTURE I
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FUTURE II
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| “Per-protocol analysis:” |
Vaccine efficacy: |
100% (95% CI, 94%–100%) |
98% (95% CI, 86%–100%) |
| • Negative for HPV 6/11/16/18 at enrollment and to 1 mo after 3rd injection |
| • Received all doses |
Composite events: |
Vaccine |
Placebo |
Vaccine |
Placebo |
| • Analysis begins 1 mo after 3rd dose |
0 |
65a |
1b |
42c |
| “Unrestricted susceptible population analysis:” |
Vaccine efficacy: |
98% (95% CI, 92%–100%) |
95% (95% CI, 85%–99%) |
| • Negative for HPV 6/11/16/18 at enrollment |
| • Analysis starts 1 d after 1st injection |
Composite events: |
Vaccine |
Placebo |
Vaccine |
Placebo |
| 2d |
89e |
3f |
62g |
| “Intention-to-treat analysis:” |
Vaccine efficacy: |
55% (95% CI, 40%–66%) |
44% (95% CI, 26%–58%) |
| • All randomized subjects, including those positive for HPV 6/11/16/18 or HPV-related cervical lesions at enrollment |
| • Analysis starts 1 d after 1st injection |
Composite events: |
Vaccine |
Placebo |
Vaccine |
Placebo |
| 71h |
155i |
83j |
148k |
|
d = day; mo = month.
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a50% cervical intraepithelial neoplasia (CIN) I, 20% CIN II, 20% CIN III, 10% adenocarcinoma in situ (AIS).
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b100% CIN III.
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c29% CIN II, 69% CIN III, 2% AIS.
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d100% CIN I.
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e52% CIN I, 19% CIN II, 22% CIN III, 7% AIS.
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f33% CIN II, 67% CIN III.
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g26% CIN II, 68% CIN III, 6% AIS.
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h27% CIN I, 18% CIN II, 54% CIN III, 1% AIS.
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i48% CIN I, 22% CIN II, 26% CIN III, 4% AIS.
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j26% CIN II, 68% CIN III, 6% AIS.
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kUnable to calculate; worst histologic diagnoses not provided.
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