TY - JOUR
T1 - Immunogenicity and safety of the bivalent HPV vaccine in female patients with juvenile idiopathic arthritis
T2 - a prospective controlled observational cohort study
AU - Heijstek, M.W.
AU - Scherpenisse, M.
AU - Groot, N.
AU - Tacke, C.E.
AU - Schepp, R.M.
AU - Buisman, A.M.
AU - Berbers, G.A.
AU - van der Klis, F.M
AU - Wulffraat, N.M.
N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
PY - 2014/8
Y1 - 2014/8
N2 - OBJECTIVES: To compare the immunogenicity and safety of the bivalent human papillomavirus (HPV)16/18 vaccine between female patients with juvenile idiopathic arthritis (JIA) and healthy female adolescents.METHODS: 68 patients and 55 healthy girls aged 12-18 years were included in a prospective controlled observational cohort and were vaccinated at 0, 1 and 6 months. Primary outcomes were immunogenicity expressed as seropositivity rate after three vaccine doses at 7 and 12 months and HPV-specific geometric mean antibody concentrations. Secondary outcomes were HPV16/18-specific memory B cell responses in a subset of participants and safety, defined as adverse events and the effect of vaccination on JIA disease activity.RESULTS: All participants were seropositive for HPV16 and HPV18 at 7 months. One patient turned seronegative at 12 months for HPV16/18. No significant differences were found between patients and controls in HPV-specific antibody concentrations; however, antibody concentrations were consistently lower in patients. No effect of methotrexate on HPV16 antibodies (p=0.79) or HPV18 antibodies (p=0.37) was detected. All patients on anti-TNFα treatment were seropositive after vaccination. The kinetics of HPV16/18 memory B cell responses was comparable between patients and controls, but the magnitude of B cell responses at 7 and 12 months appeared lower in patients. No relevant differences in adverse events were found. HPV vaccination did not aggravate JIA disease.CONCLUSIONS: The bivalent HPV16/18 vaccine is immunogenic and well tolerated in JIA patients. However, HPV-specific antibodies and B cell responses tended to be lower in patients compared with healthy controls.CLINICAL TRIAL LISTING: NCT00815282.
AB - OBJECTIVES: To compare the immunogenicity and safety of the bivalent human papillomavirus (HPV)16/18 vaccine between female patients with juvenile idiopathic arthritis (JIA) and healthy female adolescents.METHODS: 68 patients and 55 healthy girls aged 12-18 years were included in a prospective controlled observational cohort and were vaccinated at 0, 1 and 6 months. Primary outcomes were immunogenicity expressed as seropositivity rate after three vaccine doses at 7 and 12 months and HPV-specific geometric mean antibody concentrations. Secondary outcomes were HPV16/18-specific memory B cell responses in a subset of participants and safety, defined as adverse events and the effect of vaccination on JIA disease activity.RESULTS: All participants were seropositive for HPV16 and HPV18 at 7 months. One patient turned seronegative at 12 months for HPV16/18. No significant differences were found between patients and controls in HPV-specific antibody concentrations; however, antibody concentrations were consistently lower in patients. No effect of methotrexate on HPV16 antibodies (p=0.79) or HPV18 antibodies (p=0.37) was detected. All patients on anti-TNFα treatment were seropositive after vaccination. The kinetics of HPV16/18 memory B cell responses was comparable between patients and controls, but the magnitude of B cell responses at 7 and 12 months appeared lower in patients. No relevant differences in adverse events were found. HPV vaccination did not aggravate JIA disease.CONCLUSIONS: The bivalent HPV16/18 vaccine is immunogenic and well tolerated in JIA patients. However, HPV-specific antibodies and B cell responses tended to be lower in patients compared with healthy controls.CLINICAL TRIAL LISTING: NCT00815282.
KW - Adolescent
KW - Antibodies, Viral/blood
KW - Arthritis, Juvenile/immunology
KW - Child
KW - Female
KW - Follow-Up Studies
KW - Human papillomavirus 16/immunology
KW - Human papillomavirus 18/immunology
KW - Humans
KW - Papillomavirus Infections/immunology
KW - Papillomavirus Vaccines/administration & dosage
KW - Prospective Studies
KW - Uterine Cervical Neoplasms/immunology
U2 - 10.1136/annrheumdis-2013-203429
DO - 10.1136/annrheumdis-2013-203429
M3 - Article
C2 - 23723319
SN - 0003-4967
VL - 73
SP - 1500
EP - 1507
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 8
ER -