Immunogenicity and safety of vaccinations in PaedRD
| Vaccine | Studies (abstract) | Patients (juvenile)/healthy controls | LoE | Immunogenicity (LoE) | Safety (LoE) |
|---|---|---|---|---|---|
| BCG* | 10 (0) | 16124 (16063)/65 | 2B–4 | Lower responses to PPD in 115 JIA patients and 20 SLE patients several years after BCG (2B) | Local inflammation at BCG site in 8169 Kawasaki disease patients (3) |
| HAV/HBV | 9 (2) | 432 (49)/56 | 2B–3 | Good immunogenicity HAV in 10 patients (3) and HBV in 344 patients (2B)Lower responses HBV in 44 RA patients (3), and in 40 SpA patients on anti-TNFα (3) | HAV safe; no worsening of disease in 10 patients (3) HBV safe; similar disease activity as non-vaccinated patients in 44 patients (2B), no worsening of disease in 77 patients (3), no severe AE in 293 patients (3) |
| Hib | 2 (0) | 85 (0)/0 | 3 | Good immunogenicity in 85 patients (3) | Safe; no worsening of disease in 85 patients (3) |
| HPV | 1 (1) | 22 (22)/0 | 4 | NA | Safe; no serious AE in 22 patients (4) |
| Flu | 41 (4) | 2551 (131)/901 | 1B–3 | Good immunogenicity in 1035 patients (1B–3)Good immunogenicity, but lower GMC or lower responses to 1 strain in 408 patients (1B–3)Lower responses on immunosuppressive drugs in 760 patients (1B–3)Lower responses in 206 patients (1B–2B) | Safe; similar disease activity as non- vaccinated patients in 429 patients (1B–2B), no worsening of disease in 871 patients (3), similar AE as HC in 177 patients (2B) |
| Meningococcal | 1 (0) | 234 (234)/0 | 3 | Good immunogenicity in 234 patients (NeisVac-C), despite lower GMC in patients on immunosuppressive drugs (3) | Safe; no worsening of disease in 234 patients (NeisVac-C) (3) |
| MMR* | 7 (0) | 321 (229)/22 | 2B–3 | Good immunogenicity in 98 patients (3) | Safe; no worsening of disease in 222 patients (3)Case reports of flares of JIA and ITP (4) |
| Pneumococcal | 23 (1) | 1889 (63)/142 | 1B–3 | Good immunogenicity PPV in 557 patients (2A) and PCV7 in 63 JIA patients, including 31 on anti-TNFα (2B)Lower responses to PPV in 311 patients (2B), 20 patients on anti-TNFα (2A) and to PCV7 in 10 patients on anti-TNFα (3) | PPV safe; similar disease activity as non-vaccinated patients in 117 patients (1B), no worsening of disease in 157 patients (3), similar AE as HC in 131 patients (3), no serious AE in 40 patients (3)PCV safe; no worsening of disease, no severe AE in 63 JIA patients (3) |
| Polio* | 1 (0) | 115 (0)/0 | 3 | NA | Four flares after IPV/OPV vaccination in 73 SLE patients vs no flares in 37 SLE controls (3) |
| TDaP/TD/TT | 10 (1) | 501 (138)/156 | 2B–3 | Good immunogenicity TT in 316 patients, also 6 months after rituximab, and on anti-TNFα (2B)Good immunogenicity TD in 34 patients (3)Good immunogenicity TT, but lower GMC in 92 patients (3) and in 41 patients on anti-CD11a (2B)Poor responders to TT among 29 SLE patients (3) | TT safe; no worsening of disease in 113 patients, no severe AE in 103 patients (3) |
| Travellers' vaccines† | 1 (0) | 1 (0)/0 | 4 | NA | Transverse myelitis reported 3 months after rabies vaccination (4) |
| VZV* | 3 (1) | 86 (30)/47 | 2B–3 | Good immunogenicity to zoster in 55 patients (3)Responses within range of controls in 25 patients, but trend towards lower response (2B)Five of 6 IBD patients had positive immunity (4) | Safe; no worsening of disease in 86 patients (3–4), no serious AE in 31 patients (3–4), similar AE as HC in 55 patients (3)VZV-like rash in 20% of patients (4) |
| YFV* | 2 (0) | 91 (0)/15 | 2B–3 | Trend to lower GMC, 1 non-responder of 17 patients on anti-TNFα and methotrexate (2B) | Safe; similar AE as HC in 91 patients (3) |
↵* Live-attenuated vaccines, both non-live as live-attenuated OPV are available.
↵† Cholera, Japanese encephalitis, rabies, tickborne encephalitis (FSME), typhoid fever.
AE, adverse events; BCG, bacillus Calmette–Guérin; GMC, geometric mean antibody concentrations; HAV, hepatitis A virus vaccine; HBV, hepatitis B virus vaccine; HC, healthy controls; Hib, Haemophilus influenzae type B vaccine; HPV, human papillomavirus vaccine; IBD, inflammatory bowel disease; IPV, inactivated poliovirus; ITP, idiopathic thrombocytopenic purpura; JIA, juvenile idiopathic arthritis; LoE, level of evidence; MMR, measles, mumps, rubella vaccine; NA, not applicable; NeisVac-C, meningococcal serogroup C conjugate vaccine; OPV, oral poliovirus vaccines; PaedRD, paediatric patients with rheumatic diseases; PCV7, 7-valent pneumococcal conjugate vaccine; PPD, purified protein derivative of tuberculin; PPV, pneumococcal polysaccharide vaccine; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; SpA, spondylarthropathy patients; TD, tetanus-diphtheria vaccine; TDaP, tetanus-diphtheria-acellular pertussis vaccines; TNF, tumour necrosis factor; TT, tetanus toxoid vaccine; VZV, varicella zoster virus vaccine; YFV, yellow fever virus vaccines.