Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study

Grein, Ingrid Herta Rotstein; Pinto, Natalia Balera Ferreira; Groot, Noortje; Martins, Camila Bertini; Lobo, Aline; Aikawa, Nadia Emi; Barbosa, Cassia; Terreri, Maria Teresa; da Fraga, Aline Coelho Moreira; de Oliveira, Sheila Knupp Feitosa; Sztajnbok, Flavio; Paim Marques, Luciana B.; Islabão, Aline Garcia; Appenzeller, Simone; Bica, Blanca; de Oliveira Sato, Juliana; Magalhães, Claudia Saad; Ferriani, Virgínia; Pasmans, Hella; Schepp, Rutger; van der Klis, Fiona; de Roock, Sytze; Wulffraat, Nico; Pileggi, Gecilmara Salviato

doi:10.1186/s12969-020-00479-w

Pediatric Rheumatology

Table 2 Ocurrence of AEFV in JDM patients and HC after each qHPV vaccine dose

From: Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study

	After the first dose			After the second dose			After the third dose			Total
	JDM	HC	p-value^b	JDM	HC	p-value^b	JDM	HC	p-value^b	JDM	HC	p-value^b
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 abnormalities^a	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

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