Table 1 Vaccines characteristics and outcomes (randomized clinical trials)
From: Vaccination and screening programs: harmonizing prevention strategies for HPV-related diseases
Name â„¢ | GARDASIL | CERVARIX |
|---|---|---|
   L1 VLP antigens | HPV 6 (20 mg) | HPV 16 (20 mg) |
| Â | HPV 11 (40 mg) | HPV 18 (20 mg) |
| Â | HPV 16 (40 mg) | Â |
| Â | HPV 18 (20 mg) | Â |
   Expression system | Saccharomyces cerevisiae | Baculovirus |
   Adjuvant | HAAS aluminium hydroxyphosphate sulphate | ASO4 aluminium hydroxide plus 3-deacylated monophosphoryl lipid A |
   Dose schedule | 0, 2 and 6 months | 0, 1 and 6 months |
PHASE III RANDOMIZED TRIALS | Â | Â |
   Name | FUTURE I (13) and II (14) Females United to Unilaterally Reduce Endo/Ectocervical Disease | PATRICIA (16) PApilloma TRIal against Cancer In young Adults |
   Years of recruitment | 2002–2003 | 2004–2005 |
   Age of recruited subjects | 16–26 | 15–25 |
   Enrolled women | 20,583 | 18,644 |
   No. of sexual partners | ≤4 | ≤6 |
   Random comparator | Placebo (225 or 450 μg of aluminum) | Hepatitis A vaccine |
IMMUNOLOGIC RESPONSE | Â | Â |
   Seroconversion | ~100% | ~100% |
   Serologic detection method | cLIA * | binding ELISA |
   Immunogenicity | Established | Established |
   Immune memory at 6 (5?) yrs | Established | Not reported |
CLINICAL RESPONSE | Â | Â |
   Follow-up | 3 years | 15 months (interim analysis) |
   Prophylactic efficacy |  |  |
HPV 16 CIN2/3+ | Established | Established |
HPV 18 CIN2/3+ | Established | Positive trend |
HPV 16/18 VIN3 | Established | Not reported |
HPV 16/18 VaIN3 | Established | Not reported |
6/11 genital warts | Established | Not a target |
   Tolerability | Well tolerated | Well tolerated |
   Safety at 6 yrs | Established | Established |
   Therapeutic efficacy | None | None |