Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus
vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may
partly result of the need to propagate A (H3N2) virus into egg components for the preparation
of the vaccine. Other factors that may also contribute to the reduction of efficacy against A
(H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of
this particular virus subtype and the modification of the immune response to the vaccine
secondary of prior infection or vaccination.
Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza
vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant
to evaluate the safety of the vaccine in this population as well as the possibility of
reactivation of the rheumatologic disease itself. The objectives of this study are to:
Evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented
influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore /
INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus] in patients
with two systemic autoimmune rheumatic diseases (Systemic Lupus Erythematosus - Adult
and Juvenile, Primary Sjögren's Syndrome).
Assess the safety of immunization with the inactivated influenza vaccine [A / Michigan /
45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like
virus; B / Phuket / 3073/2013-like virus] in these patients with systemic autoimmune
rheumatic diseases.
Evaluate the possible association between vaccinal immunogenicity with: demographic
data, clinical and laboratorial activity of the disease, and treatment of patients with
these rheumatic diseases.
Patients with diagnosis of adult and juvenile systemic lupus erythematosus (SLE and JSLE)
(n=100) and Sjogren syndrome (SSp) (n=30) according to the classification criteria
established for these diseases will be prospectively evaluated at the Hospital das Clínicas
of the University of São Paulo (HC-FMUSP).
The control group will consist of 120 healthy individuals who will be recruited into the
vaccination campaign paired for age and sex. The juvenile control group will be composed of
50 healthy children who will be recruited in the vaccination campaign paired for age and sex.
Patients and healthy controls will be vaccinated with one dose of the inactivated and
fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore /
INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus].
At study entry (D0) and after 30-45 days, blood sample will be collected from patients (SLE,
SLE and SSp) and controls.
At entry (D0) and end of study (between D30-D45), patients will be assessed for clinical and
laboratory disease activity through specific disease indexes of inflammatory activity: SLE:
SLEDAI (lab: blood count, anti-dsDNA, complement, urine I and prot / creat ratio + 1 dry tube
for H3N2 serology); SSp: EULAR Sjogren's syndrome disease activity index (Lab: PCR, anti-Ro /
SS-A and anti-La / SS-B + 1 dry tube for H3N2 serology).
Patients and healthy controls are advised on possible side effects of the vaccine. In
addition, patients and controls are instructed to note in a standardized diary symptoms
during study period, such as pruritus, local pain, erythema, induration at the site of the
vaccine, fever, chills, headache, myalgia, arthralgia and diarrhea. Signs of airway
infections (cough, sputum, sore throat, nasal congestion or expectoration), fever (axillary
temperature> 37.8 °C), need for hospitalizations, severity of infections, sick days,
absenteeism at work, and treatment received for infections. Serious adverse events will be
defined as those resulting in hospitalization or death. A contact telephone number for
patients and controls is provided for guidance on moderate to severe adverse events.
Patients and controls are advised to contact the investigators in case of flu symptoms up to
6 months after vaccination to be evaluated clinically and with nasal swab collection for
respiratory virus.