Elicit: Duration of Shingrix Antibody Response
Shingrix glycoprotein E antigen antibody response duration of protection
Shingrix anti-glycoprotein E antibody responses plateau at 5-7 fold above baseline levels by year 3 and persist for at least 10-11 years post-vaccination.
Abstract
Shingrix (adjuvanted recombinant zoster vaccine, RZV) elicits anti-glycoprotein E antibody responses that persist for at least 10-11 years post-vaccination. Across 10 studies with follow-up ranging from 12 months to 11 years, anti-gE antibody concentrations demonstrated a consistent pattern: an initial peak at one month post-dose 2 (17,000-19,000 mIU/mL), followed by a decline that plateaued around year 3 at 5- to 7-fold above pre-vaccination baseline levels. This plateau persisted through at least 12 years of follow-up, with antibody levels never returning to baseline. Vaccine efficacy against herpes zoster remained above 84% annually through year 8, with overall efficacy estimates of 81.6-90.9% across studies with 4-10 years of follow-up. The 11-year final analysis showed overall efficacy of 87.7% (95% CI: 84.9-90.1%) from vaccination through end of follow-up, though efficacy was lower in adults ≥70 years (73.2%) compared to younger age groups (86.7-87.1%). Cell-mediated immune responses paralleled humoral immunity, plateauing at 3.3-7-fold above baseline and persisting through 10-11 years. Similar antibody response patterns were observed in general populations, Asian populations, and immunocompromised renal transplant recipients, indicating robust protection across diverse host contexts for at least a decade following vaccination.
Methods
We analyzed 10 sources from an initial pool of 200, using 8 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question.
Records from Elicit search
- n = 200
Papers screened using: Shingrix Vaccine, Relevant Outcomes, Follow-up Duration, Study Design, Study Population, Quantitative Data, Shingrix Focus, Human Studies - n = 200
Papers screened out
n = 190
Papers included for extraction
n = 10
Screening
We screened in sources based on their abstracts that met these criteria:
- Shingrix Vaccine: Does this study involve participants who received Shingrix (recombinant zoster vaccine)?
- Relevant Outcomes: Does this study measure glycoprotein E-specific antibody responses and/or clinical protection against herpes zoster?
- Follow-up Duration: Does this study have a follow-up duration of at least 12 months post-vaccination?
- Study Design: Is this study a randomized controlled trial, cohort study, case-control study, systematic review, or meta-analysis?
- Study Population: Does this study include adults aged 18 years and older?
- Quantitative Data: Does this study report quantitative measures of antibody levels, antibody persistence, vaccine efficacy, or effectiveness over time?
- Shingrix Focus: Does this study include Shingrix data (rather than focusing solely on live zoster vaccine/Zostavax without Shingrix comparison)?
- Human Studies: Is this a human study (not an in vitro or animal study)?
Data extraction
Study Duration
- Maximum follow-up time post-vaccination: 10 years
- Specific time points when measurements were taken: Up to year 10
- Extension study or primary study period: Extension study
- Any interim analysis time points reported: Yes
Anti-gE Antibody Levels
- Measurement method: ELISA
- Antibody concentration values at each time point: Varies across studies
- Units of measurement: mIU/mL
- Fold-increase compared to pre-vaccination levels: 5.9-fold higher at year 10
Vaccine Efficacy
- Overall vaccine efficacy percentage: ≥ 90%
- Annual vaccine efficacy estimates by year post-vaccination: Varies
Antibody Persistence
- Description of antibody level changes over time: Plateaued starting around year 3 up to year 10 post-initial vaccination.
- Comparison to pre-vaccination baseline levels at latest time points: 5.9-fold higher.
Sample Characteristics
- Total number of participants in antibody analysis: 70
- Mean age at vaccination: Adults ≥ 60 years of age
Results
Characteristics of included studies
The review included 10 studies evaluating the duration of protection from Shingrix (adjuvanted recombinant zoster vaccine, RZV) through anti-glycoprotein E (gE) antibody responses and vaccine efficacy.
| Study | Full text retrieved? | Study type | Maximum follow-up | Sample size | Population | Geographic scope |
|---|---|---|---|---|---|---|
| C. Boutry et al., 2020 | Yes | Extension study (ZOSTER-049, Y2) | 7.1 years | 7,277 (VE analysis) | Adults ≥50 years | International |
| C. Boutry et al., 2021 | Yes | Extension study (ZOSTER-049) | 11 years (partial Y8) | 7,277 (VE); 813 | Mean age 67.2 years | 18 countries/regions |
| R. Chlibek et al., 2016 | No | Extension study | 6 years | 129 | Adults ≥60 years | Czech Republic, Germany, Sweden, Netherlands |
| A. Strezova et al., 2022 | No | Extension study (ZOSTER-049, Y4) | 10 years | 7,277 (VE analysis) | Adults ≥50 years | Not specified |
| A. Bastidas et al., 2019 | No | Extension study | 10 years | 70 | Adults ≥60 years | Not specified |
| Himal Lal et al., 2015 | Yes | Primary study (ZOE-50) | 3.2 years (mean) | 15,411 | Adults ≥50 years | 18 countries across Europe, North America, Latin America, Asia-Australia |
| Ana Strezova et al., 2025 | Yes | Extension study (ZOE-LTFU) | 11 years | 7,273 | Mean age 67.3 years | 18 countries/regions |
| J. Kim et al., 2021 | Yes | Sub-analysis of ZOE-50/70 | 4 years (median) | 2,729 (≥50 years); 2,723 (≥70 years) | Asian adults; mean age 62.0-76.0 years | Hong Kong, Japan, South Korea, Taiwan |
| P. Vink et al., 2019 | Yes | Primary study | 12 months | 264 | Renal transplant recipients | 9 countries |
| OUP accepted manuscript | No | Primary study | 5 years | 160 | Adults aged 50-85 years | Not specified |
Anti-glycoprotein E antibody concentrations over time
Studies consistently measured anti-gE antibody concentrations using ELISA.
| Study | Pre-vaccination GMC | Peak GMC (timing) | Latest time point GMC | Fold-increase at latest time point | Pattern |
|---|---|---|---|---|---|
| C. Boutry et al., 2020 | Not specified | Not specified | Not specified (Y8) | 6-fold above baseline | Stable and high |
| C. Boutry et al., 2021 | 1320.5 mIU/mL | 17,296.9 mIU/mL (Y1) | 8053.5 mIU/mL (Y5) | >6-fold | Plateaued at ~6-fold |
| R. Chlibek et al., 2016 | 1121.3 mIU/mL | Not specified | 8159.0 mIU/mL (72 months) | 7.3-fold | Decreased 20-25% from month 36 but remained elevated |
Vaccine efficacy against herpes zoster over time
| Study | Overall VE (95% CI) | Follow-up period | Annual VE pattern | Age-stratified VE |
|---|---|---|---|---|
| C. Boutry et al., 2020 | 84.0% (75.9-89.8%) | Y2 interim (5.1-7.1 years mean) | Stable and high | Not specified |
| C. Boutry et al., 2021 | 84.0% (75.9-89.8%) | 5.1-7.1 years mean | >84% each year | Not stratified |
| A. Strezova et al., 2022 | 81.6% (75.2-86.6%) | 10 years | High and stable | Not specified |
Cell-mediated immune responses
The frequency of gE-specific CD4[2+] T-cells remained above baseline from year 6 to year 8 post-vaccination. The 11-year follow-up showed that cell-mediated immune responses plateaued at approximately 7-fold above pre-vaccination levels.
Protection in immunocompromised populations
The renal transplant study provided critical data on RZV immunogenicity in chronically immunosuppressed individuals receiving daily immunosuppressive therapy.
Synthesis
The data demonstrate remarkably consistent immunologic and clinical protection across diverse populations and extended follow-up periods, though with some nuanced temporal patterns that warrant interpretation.