Immune Persistence Following a Single Dose of Varicella Vaccine: 5-Year and 8-Year Follow-Up of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants
2.3. Vaccines
2.4. Immunogenicity Assessment
2.5. Sample Size Determination and Statistical Analysis
3. Results
3.1. Study Participants
3.2. Immunogenicity and Immune Persistence in Overall Population
3.2.1. 5-Year Immune Persistence Analysis
3.2.2. 8-Year Immune Persistence Analysis
3.2.3. Full Series Immune Persistence Analysis
3.3. Immunogenicity and Immune Persistence in Different Age Subgroups
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Analysis Dataset | Variable | VarV Group (N = 247) | Placebo Group (N = 240) | Total (N = 487) | p-Value |
---|---|---|---|---|---|
IPS | N | 247 | 240 | 487 | |
Age of vaccination (years, mean ± SD) | 6.5 ± 2.8 | 6.2 ± 2.8 | 6.3 ± 2.8 | 0.2898 | |
Gender (male, %) | 51.4% | 48.8% | 50.1% | 0.5562 | |
IPS2 | N | 218 | 204 | 422 | |
Age of vaccination (years, mean ± SD) | 6.3 ± 2.7 | 6.0 ± 2.8 | 6.1 ± 2.7 | 0.2185 | |
Gender (male, %) | 51.8% | 49.5% | 50.7% | 0.6331 |
Time Point | Variable | 1–4 Years Old | 5–8 Years Old | 9–12 Years Old | ||||||
---|---|---|---|---|---|---|---|---|---|---|
VarV Group | Placebo Group | p-Value | VarV Group | Placebo Group | p-Value | VarV Group | Placebo Group | p-Value | ||
Before vaccination | N | 51 | 63 | 141 | 126 | 55 | 51 | |||
Seropositive (≧1:4) rate % (95%CI) | 39.22 (25.84, 53.89) | 47.62 (34.88, 60.59) | 0.3686 | 79.43 (71.82, 85.77) | 74.60 (66.08, 81.93) | 0.3481 | 89.09 (77.75, 95.89) | 90.20 (78.59, 96.74) | 0.8521 | |
Seropositive (≧1:8) rate % (95%CI) | 29.41 (17.49, 43.83) | 38.10 (26.15, 51.20) | 0.3312 | 53.90 (45.31, 62.32) | 57.94 (48.82, 66.67) | 0.5074 | 67.27 (53.29, 79.32) | 84.31 (71.41, 92.98) | 0.0416 | |
GMT (1:) (95%CI) | 3.44 (2.79, 4.25) | 4.23 (3.36, 5.31) | 0.1998 | 7.50 (6.25, 9.01) | 7.21 (5.98, 8.68) | 0.7586 | 9.79 (7.43, 12.90) | 14.75 (10.78, 20.18) | 0.0508 | |
30 days after vaccination | Seropositive (≧1:4) rate % (95%CI) | 100.00 (93.02, 100.00) | 52.38 (39.41, 65.12) | <0.0001 | 100.00 (97.42, 100.00) | 74.60 (66.08, 81.93) | <0.0001 | 100.00 (93.51, 100.00) | 90.20 (78.59, 96.74) | 0.0548 |
Seropositive (≧1:8) rate % (95%CI) | 96.08 (86.54, 99.52) | 42.86 (30.46, 55.95) | <0.0001 | 95.74 (90.97, 98.42) | 61.11 (52.02, 69.66) | <0.0001 | 98.18 (90.28, 99.95) | 84.31 (71.41, 92.98) | 0.0271 | |
GMT (1:) (95%CI) | 23.09 (18.83, 28.32) | 4.82 (3.77, 6.18) | <0.0001 | 48.36 (38.94, 60.07) | 7.66 (6.34, 9.25) | <0.0001 | 66.47 (47.26, 93.48) | 16.00 (11.41, 22.43) | <0.0001 | |
5 years after vaccination | Seropositive (≧1:4) rate % (95%CI) | 100.00 (93.02, 100.00) | 77.78% (65.54, 87.28) | 0.0003 | 100.00 (97.42, 100.00) | 82.54 (74.77, 88.72) | <0.0001 | 100.00 (93.51, 100.00) | 80.39 (66.88, 90.18) | 0.0004 |
Seropositive (≧1:8) rate % (95%CI) | 88.24 (76.13, 95.56) | 60.32% (47.20, 72.43) | 0.0009 | 87.94 (81.40, 92.82) | 65.08 (56.08, 73.35) | <0.0001 | 92.73 (82.41, 97.98) | 66.67 (52.08, 79.24) | 0.0008 | |
GMT (1:) (95%CI) | 10.79 (9.01, 12.91) | 6.93 (5.55, 8.66) | 0.0025 | 13.60 (11.81, 15.68) | 7.61 (6.47, 8.95) | <0.0001 | 17.26 (13.71, 21.72) | 9.04 (6.71, 12.19) | 0.0008 | |
8 years after vaccination | N | 47 | 60 | 128 | 106 | 43 | 38 | |||
Seropositive (≧1:4) rate % (95%CI) | 100 (92.45, 100.00) | 86.67 (75.41, 94.06) | 0.0088 | 99.22 (95.72, 99.98) | 92.45 (85.67, 96.69) | 0.0123 | 100 (91.78, 100.00) | 92.11 (78.62, 98.34) | 0.0989 | |
Seropositive (≧1:8) rate % (95%CI) | 87.23 (74.26, 95.17) | 63.33 (49.90, 75.41) | 0.0052 | 86.72 (79.59, 92.07) | 76.42 (67.18, 84.12) | 0.0409 | 95.35 (84.19, 99.43) | 86.84 (71.91, 95.59) | 0.2440 | |
GMT (1:) (95%CI) | 11.74 (8.84, 15.59) | 8.48 (6.60, 10.88) | 0.0866 | 13.17 (11.29, 15.35) | 9.80 (8.30, 11.56) | 0.0103 | 17.07 (13.29, 21.91) | 13.09 (9.80, 17.49) | 0.1628 |
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Wang, Y.; Lei, X.; Huang, L.; Ma, Y.; Yuan, H.; Zhao, D.; Meng, F. Immune Persistence Following a Single Dose of Varicella Vaccine: 5-Year and 8-Year Follow-Up of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Vaccines 2025, 13, 1024. https://doi.org/10.3390/vaccines13101024
Wang Y, Lei X, Huang L, Ma Y, Yuan H, Zhao D, Meng F. Immune Persistence Following a Single Dose of Varicella Vaccine: 5-Year and 8-Year Follow-Up of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Vaccines. 2025; 13(10):1024. https://doi.org/10.3390/vaccines13101024
Chicago/Turabian StyleWang, Yanxia, Xiangling Lei, Lili Huang, Yuehong Ma, Hongxue Yuan, Dongyang Zhao, and Fanhong Meng. 2025. "Immune Persistence Following a Single Dose of Varicella Vaccine: 5-Year and 8-Year Follow-Up of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial" Vaccines 13, no. 10: 1024. https://doi.org/10.3390/vaccines13101024
APA StyleWang, Y., Lei, X., Huang, L., Ma, Y., Yuan, H., Zhao, D., & Meng, F. (2025). Immune Persistence Following a Single Dose of Varicella Vaccine: 5-Year and 8-Year Follow-Up of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. Vaccines, 13(10), 1024. https://doi.org/10.3390/vaccines13101024