Table 4.
Prophylactic efficacy of VLP vaccines against infection and lesions related to vaccine targeted HPV types.
| Vaccine | Study | Number of subjects |
Endpoints | Efficacya |
|||
|---|---|---|---|---|---|---|---|
| Vaccine group | Placebo group | ATP | MITT | ITT | |||
| Merck 007 | 235 | 233 | HPV persistence (4 months) | 96 (83 – 100) | 94 (83 - 98) | NR | |
| Merck 007 | 235 | 233 | External genital lesions | 100 (<0–100) | 100 (<0–100) | NR | |
| Merck 007 | 235 | 233 | CIN 1+, AIS | 100 (<0–100) | 100 (31 – 100) | NR | |
| Gardasil® | |||||||
| FUTURE I | 2,241 | 2,258 | CIN 1+, AIS | 100 (94 – 100) | 98 (92 – 100) | 55 (40 – 66) | |
| FUTURE I | 2,261 | 2,279 | External genital lesions | 100 (94 – 100) | 95 (87 – 99) | 73 (58 – 83) | |
| FUTURE II | 6,087 | 6,080 | CIN 2+, AIS | 98 (86 – 100) | 95 (85 – 99) | 44 (26 – 58) | |
| GSK 001/007 | 414 | 385 | HPV persistence (6 months) | 96 (75 – 100) | 94 (78 – 99) | NR | |
| GSK 001/007 | 414 | 385 | HPV persistence (12 months) | 100 (52 – 100) | 94 (61 – 100) | NR | |
| GSK 001/007 | 481 | 470 | CIN 1+ | NR | 100 (42 – 100) | NR | |
| GSK 001/007 | 481 | 470 | CIN 2+ | NR | 100 (−8 – 100) | NR | |
| Cervarix® | |||||||
| PATRICIA | 6,344 | 6,402 | HPV persistence (6 months) | NR | 80 (70 – 87) | NR | |
| PATRICIA | 3,386 | 3,437 | HPV persistence (12 months) | NR | 76 (48 – 90) | NR | |
| PATRICIA | 7,788 | 7,838 | CIN 1+ | NR | 89 (59 – 99) | NR | |
| PATRICIA | 7,788 | 7,838 | CIN 2+ | NR | 90 (53 – 99) | NR | |
a
95% confidence intervals, except 97.9% confidence intervals used in PATRICIA.
AIS: Adenocarcinoma in situ; ATP: According to protocol; CIN: Cervical intraepithelial neoplasia; CIN1+: CIN grade 1 or worse; CIN2+: CIN grade 2 or worse; FUTURE: Females united to unilaterally reduce endo/ectocervical disease; GSK: GlaxoSmithKline; ITT: Intention to treat; MITT: Modified intention to treat; NR: Not reported; PATRICIA: Papilloma trial against cancer in young adults.