Table 2.
Ocurrence of AEFV in JDM patients and HC after each qHPV vaccine dose
| After the first dose | After the second dose | After the third dose | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| JDM | HC | p-valueb | JDM | HC | p-valueb | JDM | HC | p-valueb | JDM | HC | p-valueb | |
| Vaccinated patients during the study, n | 42 | 39 | NA | 44 | 38 | NA | 42 | 35 | NA | 128 | 112 | NA |
| Completed diaries after vaccine dose, n (%) | 40 (95.2) | 38 (97.4) | NA | 41 (93.2) | 38 (100) | NA | 40 (95.2) | 35 (100) | NA | 121 (94.5) | 111 (99.1) | NA |
| Local AEFV, n (%) | ||||||||||||
| Redness | 5 (12.5) | 4 (10.5) | 1.000 | 2 (4.9) | 3 (7.9) | 0.667 | 0 (0.0) | 2 (5.7) | 0.214 | 7 (5.8) | 9 (8.1) | 0.601 |
| Bruise | 0 (0.0) | 0 (0.0) | 1.000 | 1 (2.4) | 1 (2.6) | 1.000 | 0 (0.0) | 5 (14.3) | 0.019 | 1 (0.8) | 6 (5.4) | 0.058 |
| Edema | 5 (12.5) | 5 (13.2) | 1.000 | 4 (9.8) | 8 (21.1) | 0.215 | 1 (2.5) | 8 (22.9) | 0.010 | 10 (8.3) | 21 (18.9) | 0.021 |
| Induration | 6 (15.0) | 9 (23.7) | 0.396 | 4 (9.8) | 4 (10.5) | 1.000 | 4 (10.0) | 5 (14.3) | 0.726 | 14 (11.6) | 18 (16.2) | 0.346 |
| Pain | 22 (55.0) | 23 (60.5) | 0.653 | 19 (46.3) | 23 (60.5) | 0.261 | 16 (40.0) | 19 (54.3) | 0.252 | 57 (47.1) | 65 (58.6) | 0.115 |
| Systemic AEFV, n (%) | ||||||||||||
| Fever | 1 (2.5) | 0 (0.0) | 1.000 | 1 (2.4) | 0 (0.0) | 1.000 | 0 (0.0) | 1 (2.9) | 0.467 | 2 (1.7) | 1 (0.9) | 1.000 |
| New cutaneous abnormalitiesa | 2 (5.0) | 0 (0.0) | 0.494 | 1 (2.4) | 0 (0.0) | 1.000 | 1 (2.5) | 0 (0.0) | 1.000 | 4 (3.3) | 0 (0.0) | 0.052 |
| Itchiness | 1 (2.5) | 1 (2.6) | 1.000 | 3 (7.3) | 1 (2.6) | 0.616 | 7 (17.5) | 0 (0.0) | 0.013 | 11 (9.1) | 2 (1.8) | 0.020 |
| Headache | 9 (22.5) | 10 (26.3) | 0.794 | 10 (24.4) | 10 (26.3) | 1.000 | 6 (15.0) | 7 (20.0) | 0.761 | 25 (20.7) | 27 (24.3) | 0.534 |
| Nausea | 9 (22.5) | 1 (2.6) | 0.014 | 1 (2.4) | 2 (5.3) | 0.606 | 2 (5.0) | 4 (11.4) | 0.409 | 12 (9.9) | 7 (6.3) | 0.346 |
| Vomiting | 2 (5.0) | 0 (0.0) | 0.494 | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 2 (1.7) | 0 (0.0) | 0.498 |
| Fatigue | 6 (15.0) | 7 (18.4) | 0.767 | 4 (9.8) | 7 (18.4) | 0.338 | 4 (10.0) | 5 (14.3) | 0.726 | 14 (11.6) | 19 (17.1) | 0.263 |
| Fainting | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 |
| Initial or worsened muscular pain | 2 (5.0) | 1 (2.6) | 1.000 | 2 (4.9) | 1 (2.6) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 4 (3.3) | 2 (1.8) | 0.685 |
| Initial or worsened articular pain | 1 (2.5) | 0 (0.0) | 1.000 | 1 (2.4) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 2 (1.7) | 0 (0.0) | 0.499 |
| Severe AEFV, n (%) | ||||||||||||
| WHO definition | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 | 0 (0.0) | 0 (0.0) | 1.000 |
JDM juvenile dermatomyositis, HC healthy controls, AEFV adverse events following vaccination, qHPV quadrivalent human papillomavirus vaccine, NA Not applicable, WHO World Health Organization
aPatients described new rash on face or on body, that subsided in a maximum of 4 days
bStatistical significance was defined as a p-value < 0.05