Safety of Adjuvanted Recombinant Herpes Zoster Virus Vaccination in Fragile Populations: An Observational Real-Life Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Recombinant Vaccine (RZV)
2.2. Population and Study Design
2.3. Demographic and AEFI Data Collection
2.4. Statistical Analysis
3. Results
3.1. RZV Vaccine Is Safe with Local Mild AEFIs
3.2. Recurrence of AEFIs after First Dose of RZV Is Frequent While Not Threatening
3.3. Females More Frequently Experience Local Skin AEFIs
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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First RZV Dose (n = 271) | Completed RZV (n = 254) | |
---|---|---|
Mean age ± SD, years (range) | 56 ± 13 (20–84) | 56 ± 12 (30–84) |
Males/Females, n (%) | 178 (66)/93 (34) | 165 (65)/89 (35) |
Fragility, n (%) | ||
Type 2 diabetes | 2 (0.7) | 2 (0.8) |
Hematological malignancies | 4 (1.5) | 4 (1.6) |
Hematopoietic stem cell transplant | 10 (3.7) | 9 (3.5) |
Dialysis | 19 (7.0) | 16 (6.3) |
Kidney transplant | 209 (77.1) | 196 (77.2) |
Liver transplant | 13 (4.8) | 13 (5.1) |
HIV infection | 11 (4.1) | 11 (4.3) |
Systemic vasculitis | 1 (0.4) | 1 (0.4) |
Immunocompetent subjects aged ≥65 years | 2 (0.7) | 2 (0.8) |
First RZV Dose (n = 271) | Completed RZV (n = 254) | p Value | |
---|---|---|---|
Incidence, n (incidence rates) | 101 (37) | 105 (41) | 0.34 |
Age ranges, years, n (%) | |||
20–30 | 3 (3.0) | 6 (6) | |
31–40 | 8 (7.9) | 11 (10) | |
41–50 | 18 (17.8) | 22 (21) | |
51–60 | 36 (35.6) | 30 (29) | |
61–70 | 27 (26.7) | 22 (21) | |
≥71 | 9 (9.0) | 14 (13) | |
Total AEFI duration (hours), mean ± SD, | 90 ± 157 | 53 ± 76 | 0.03 |
Local AEFI duration (hours), mean ± SD, (n) | 110 ± 176 (77) | 65 ± 88 (70) | 0.06 |
p value within group | 0.03 | 0.05 | |
Systemic AEFI duration (hours), mean ± SD (n) | 51 ± 57 (46) | 41 ± 33 (58) | 0.27 |
Clinical manifestations, n (%) | |||
Pain at the inoculation site | 61 (60) | 65 (62) | 0.82 |
Fever | 28 (28) | 41 (39) | 0.09 |
Fatigue—Exhaustion | 20 (20) | 20 (19) | 0.89 |
Local skin reactions | 25 (25) | 13 (12) | 0.02 |
Headache | 6 (6) | 8 (8) | 0.63 |
Bone pain | 3 (3) | 9 (9) | 0.09 |
Gastrointestinal symptoms | 4 (4) | 9 (9) | 0.17 |
Paresthesia | 1 (1) | 0 (0) | 0.31 |
Stomatitis | 1 (1) | 0 (0) | 0.31 |
Rash at nose–lips and forehead | 1(1) | 0 (0) | 0.31 |
Cutaneous systemic rash | 1 (1) | 0 (0) | 0.31 |
Flushes | 0 (0) | 1 (1) | 0.33 |
Muscle aches | 0 (0) | 2 (2) | 0.16 |
AEFIs Clinical Manifestations, n (%) | After First Dose (n = 62) | After Second Dose (n = 62) | p Value | After Only Second Dose (n = 43) | p Value |
---|---|---|---|---|---|
Pain at the inoculation site | 36 (58) | 37 (60) | 0.86 | 30 (70) | 0.29 |
Fever | 21 (34) | 22 (35) | 0.85 | 19 (44) | 0.37 |
Fatigue—Exhaustion | 12 (19) | 15 (24) | 0.51 | 5 (12) | 0.11 |
Local skin reactions | 23 (37) | 10 (16) | 0.01 | 4 (9) | 0.31 |
Headache | 6 (10) | 6 (10) | 0.99 | 2 (5) | 0.34 |
Bone pain | 3 (5) | 6 (10) | 0.30 | 2 (5) | 0.34 |
Gastrointestinal symptoms | 2 (3) | 3 (5) | 0.65 | 6(14) | 0.10 |
Paresthesia | 1 (2) | 0 (0) | 0.32 | - | - |
Muscle aches | 0 (0) | 1 (2) | 0.32 | 1 (2) | 0.79 |
Flushes | 0 (0) | 0 (0) | - | 1 (2) | 0.23 |
Total AEFI duration (hours), mean ± SD (n) | 76 ± 125 (78) | 58 ± 87 (74) | 0.31 | 40 ± 33 (54) | 0.15 |
Local AEFI duration (hours), mean ± SD (n) | 97 ± 153 (45) | 72 ± 113 (40) | 0.62 | 51 ± 33.4 (31) | 0.32 |
p value within group | 0.09 | 0.15 | - | 0.20 | - |
Systemic AEFI duration (hours), mean ± SD (n) | 48 ± 62 (33) | 42 ± 33 (34) | 0.40 | 39 ± 34 (23) | 0.74 |
First RZV Dose | Completed RZV | |||||
---|---|---|---|---|---|---|
Females n = 44 | Males n = 57 | p Value | Females n = 45 | Males n = 60 | p Value | |
AEFIs, (%) | 47% | 32% | 0.01 | 51% | 36% | 0.03 |
Clinical manifestations n (%) | ||||||
Pain at the inoculation site | 24 (55) | 38 (67) | 0.22 | 30 (67) | 37 (62) | 0.59 |
Fever | 8 (18) | 20 (35) | 0.06 | 16 (36) | 25 (42) | 0.53 |
Fatigue—Exhaustion | 11 (25) | 9 (16) | 0.25 | 11 (24) | 9 (15) | 0.22 |
Local skin reactions | 16 (36) | 9 (16) | 0.02 | 11 (24) | 2 (3) | 0.01 |
Headache | 4 (9) | 2 (4) | 0.24 | 4 (9) | 4 (7) | 0.67 |
Bone pain | 2 (5) | 1 (2) | 0.41 | 4 (9) | 4 (7) | 0.67 |
Gastrointestinal symptoms | 1 (2) | 3 (5) | 0.45 | 3 (7) | 6 (10) | 0.55 |
Stomatitis | 1 (2) | 0 (0) | 0.25 | 0 (0) | 0 (0) | - |
Cutaneous systemic rash | 1 (2) | 0 (0) | 0.25 | 0 (0) | 0 (0) | - |
Paresthesia | 0 (0) | 1 (2) | 0.38 | 0 (0) | 0 (0) | - |
Muscle aches | 0 (0) | 0 (0) | - | 2 (4) | 0 (0) | 0.10 |
Flushes | 0 (0) | 0 (0) | - | 0 (0) | 1 (2) | 0.38 |
Rash at nose–lips and forehead | 0 (0) | 1 (2) | 0.38 | 0 (0) | 0 (0) | - |
Total AEFI duration (hours), mean ± SD (n) | 82 ± 114 (54) | 93 ± 167 (69) | 0.68 | 56 ± 35 (57) | 51 ± 86 (71) | 0.68 |
Local AEFI duration (hours), mean ± SD, (n) | 92 ± 130 (34) | 120 ± 202 (45) | 0.48 | 64 ± 46 (34) | 60 ± 114 (37) | 0.85 |
p value within group | 0.40 | 0.07 | 0.07 | 0.39 | ||
Systemic AEFI duration (hours), mean ± SD (n) | 65 ± 80 (20) | 42 ± 26 (24) | 0.19 | 44 ± 33 (23) | 42 ± 36 (34) | 0.83 |
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Share and Cite
Costantino, M.; Giudice, V.; Moccia, G.; Longanella, W.; Caruccio, S.; Tremiterra, G.; Sinopoli, P.; Benvenuto, D.; Serio, B.; Malatesta, F.; et al. Safety of Adjuvanted Recombinant Herpes Zoster Virus Vaccination in Fragile Populations: An Observational Real-Life Study. Vaccines 2024, 12, 990. https://doi.org/10.3390/vaccines12090990
Costantino M, Giudice V, Moccia G, Longanella W, Caruccio S, Tremiterra G, Sinopoli P, Benvenuto D, Serio B, Malatesta F, et al. Safety of Adjuvanted Recombinant Herpes Zoster Virus Vaccination in Fragile Populations: An Observational Real-Life Study. Vaccines. 2024; 12(9):990. https://doi.org/10.3390/vaccines12090990
Chicago/Turabian StyleCostantino, Maria, Valentina Giudice, Giuseppina Moccia, Walter Longanella, Simona Caruccio, Giuliana Tremiterra, Pio Sinopoli, David Benvenuto, Bianca Serio, Francesca Malatesta, and et al. 2024. "Safety of Adjuvanted Recombinant Herpes Zoster Virus Vaccination in Fragile Populations: An Observational Real-Life Study" Vaccines 12, no. 9: 990. https://doi.org/10.3390/vaccines12090990