Three Phase 3 trials evaluated live-attenuated and recombinant subunit shingles vaccines.
Oxman et al., NEJM 2005
| Criterion | Met |
|---|---|
| Control Group | ✅ |
| Randomized | ✅ |
| Double-Blind | ✅ |
| Placebo-Controlled | ✅ |
| Large Sample (1,000+) | ✅ |
| Long Follow-up (1yr+) | ✅ |
| Independent Funding | ✅ |
| Peer-Reviewed | ✅ |
| Results Reproduced | ✅ |
Efficacy waned below 50% by years 6–7. Zostavax no longer recommended over Shingrix.
Lal et al., NEJM 2015
| Criterion | Met |
|---|---|
| Control Group | ✅ |
| Randomized | ✅ |
| Double-Blind | ✅ |
| Placebo-Controlled | ✅ |
| Large Sample (1,000+) | ✅ |
| Long Follow-up (1yr+) | ✅ |
| Independent Funding | ❌ |
| Peer-Reviewed | ✅ |
| Results Reproduced | ✅ |
Higher reactogenicity than typical vaccines: arm soreness, fever, fatigue in ~80% of recipients.
Dagnew et al., NEJM 2022
| Criterion | Met |
|---|---|
| Control Group | ✅ |
| Randomized | ✅ |
| Double-Blind | ✅ |
| Placebo-Controlled | ✅ |
| Large Sample (1,000+) | ✅ |
| Long Follow-up (1yr+) | ❌ |
| Independent Funding | ❌ |
| Peer-Reviewed | ✅ |
| Results Reproduced | ✅ |
Substantially lower efficacy in immunocompromised populations vs. healthy adults.
| Criterion | Zostavax | Shingrix Phase 3 | Shingrix in Immunocompromised Adults |
|---|---|---|---|
| Control Group | ✅ | ✅ | ✅ |
| Randomized | ✅ | ✅ | ✅ |
| Double-Blind | ✅ | ✅ | ✅ |
| Placebo-Controlled | ✅ | ✅ | ✅ |
| Large Sample (1,000+) | ✅ | ✅ | ✅ |
| Long Follow-up (1yr+) | ✅ | ✅ | ❌ |
| Independent Funding | ✅ | ❌ | ❌ |
| Peer-Reviewed | ✅ | ✅ | ✅ |
| Results Reproduced | ✅ | ✅ | ✅ |
| Total score | 9/9 | 8/9 | 7/9 |