Table 1.
Comparison of efficacy and effectiveness of HPV vaccines.
| HPV Vaccine type | Bivalent | Quadrivalent | Nonavalent | |
|---|---|---|---|---|
| HPV types included | 16, 18 | 6, 11, 16, 18 | 6, 11, 16, 18 31, 33, 45, 52, 58 | |
| Efficacy in HPV-naïve women* | Prevention of vaccine-specific HPV type infection | 94.3%+ (HPV16/18) at 3.6y 87.9% (HPV16/18) at 4y | 97% 2+ (HPV16) at 3.7y 100% (HPV18) at 3.7y | 96%2++(HPV16/18) at 4.5y |
| Prevention of CIN2+ associated with vaccine-specific HPV types | 92.9% at 3.6y | 100% (CIN2) at 3.7y 97% (CIN3) at 3.7y | 96.3% at 4.5y | |
| Prevention of CIN2+ associated with any HPV type | 61.9% at 3.6y | No data | NS | |
| Efficacy in all women (including HPV-exposed) | Prevention of vaccine-specific HPV type infection | 76.4% at 4y | 42% (HPV16) at 3.7y 79% (HPV18) at 3.7y | 80.2% at 4.5y |
| Prevention of CIN2+ associated with vaccine-specific HPV types | 52.8% (CIN2+) at 3.6y 33.6% (CIN3+) at 3.6y | 57% (CIN2) at 3.7y 45% (CIN3) at 3.7y | NSD from quadrivalent | |
| Prevention of CIN2+ associated with any HPV type | 30.4% (CIN2+) at 3.6y 33.4% (CIN3+) at 3.6y | 17% (CIN2+) at 3.7y | NSD from quadrivalent | |
| Cross-protection | Efficacy in preventing CIN2 lesions associated with HPV types 31, 33, 45, 52, 58 | 31.5% at 3.6y (all women) 51.3% at 4y (HPV-naïve, and only 31,33,45) | NS$ | N/A |
| Immunogenicity | Vaccine-specific HPV types | 100% at 3.6y 99% at 4.5y | 100% (HPV16) at 3y 76% (HPV18) at 3y | NSD from quadrivalent at 7m |
| HPV 16/18 change in prevalence pre- and post-vaccination | 19.1% → 6.5% in 16–18 y/o | 11.5% → 5.1% in 14–19 y/o | N/A | |
| Commonly reported adverse events | Injection site reaction Fatigue Headache Myalgia | Injection site reaction SyncopeDizziness Nausea Headache Fever | Injection site reaction Headache Fever DizzinessNausea Fatigue |
HPV-naïve in the bivalent vaccine efficacy trial included women who were naïve to 14 high-risk HPV types, including 16 and 18, at start of study in this analysis. HPV-naïve in the quadrivalent vaccine efficacy trial included women who were naïve to HPV 16/18 at start of study in this analysis. HPV-naïve in the nonavalent vaccine efficacy trial included women who were naïve to HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59.
Follow-up data at median 3.6 y is from industry-funded efficacy study designed for FDA approval.
Follow-up data at median 3.7 y is from industry-funded efficacy study designed for FDA approval.
Follow-up data up to maximum of 54 months is from industry-funded study designed to show non-inferiority to quadrivalent vaccine for FDA approval.
When lesions co-infected with HPV 16 and 18 are excluded.