Key result
Non-adjuvanted H1N1 vaccination achieves similar seroprotection in mixed connective tissue disease versus healthy controls.
Why the study?
The immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with mixed connective tissue disease compared to healthy controls was unclear.
Does the non-adjuvanted influenza A H1N1 vaccine provide adequate immunogenicity in patients with mixed connective tissue disease compared to healthy controls?
Cohort (n=138)
Does the non-adjuvanted influenza A H1N1 vaccine provide adequate immunogenicity in patients with mixed connective tissue disease compared to healthy controls?
Absolute Event Rate: 75.4% vs 71%
p-value: p=0.7
The non-adjuvanted influenza A/H1N1 vaccine is safe and elicits an adequate immune response in patients with mixed connective tissue disease, comparable to healthy controls.
Supports comparable immunogenicity in mixed connective tissue disease; leaves open need for randomized trials to confirm protection.
OBJECTIVE: To assess the potential acute effects regarding the immunogenicity and safety of non-adjuvanted influenza A H1N1/2009 vaccine in patients with mixed connective tissue disease and healthy controls. METHODS: Sixty-nine mixed connective tissue disease patients that were confirmed by Kasukawa's classification criteria and 69 age- and gender-matched controls participated in the study; the participants were vaccinated with the non-adjuvanted influenza A/California/7/2009 (H1N1) virus-like strain. The percentages of seroprotection, seroconversion, geometric mean titer and factor increase in the geometric mean titer were calculated. The patients were clinically evaluated, and blood samples were collected pre- and 21 days post-vaccination to evaluate C-reactive protein, muscle enzymes and autoantibodies. Anti-H1N1 titers were determined using an influenza hemagglutination inhibition assay. ClinicalTrials.gov: NCT01151644. RESULTS: Before vaccination, no difference was observed regarding the seroprotection rates (p = 1.0) and geometric mean titer (p = 0.83) between the patients and controls. After vaccination, seroprotection (75.4% vs. 71%, (p = 0.7), seroconversion (68.1% vs. 65.2%, (p = 1.00) and factor increase in the geometric mean titer (10.0 vs. 8.0, p = 0.40) were similar in the two groups. Further evaluation of seroconversion in patients with and without current or previous history of muscle disease (p = 0.20), skin ulcers (p = 0.48), lupus-like cutaneous disease (p = 0.74), secondary Sjogren syndrome (p = 0.78), scleroderma-pattern in the nailfold capillaroscopy (p = 1.0), lymphopenia #1000/mm³ on two or more occasions (p = 1.0), hypergammaglobulinemia $1.6 g/d (p = 0.60), pulmonary hypertension (p = 1.0) and pulmonary fibrosis (p = 0.80) revealed comparable rates. Seroconversion rates were also similar in patients with and without immunosuppressants. Disease parameters, such as C-reactive protein (p = 0.94), aldolase (p = 0.73), creatine phosphokinase (p = 0.40) and ribonucleoprotein antibody levels (p = 0.98), remained largely unchanged pre and post-vaccination. No severe side effects were reported. CONCLUSIONS: The non-adjuvanted influenza A/H1N1 vaccination immune response in mixed connective tissue disease patients is adequate and does not depend on the disease manifestations and therapy.
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Miossi et al. (2013) conducted a cohort in Mixed connective tissue disease (n=138). Non-adjuvanted influenza A/California/7/2009 (H1N1) vaccine vs. Healthy controls was evaluated on Seroprotection (p=0.7). Non-adjuvanted influenza A/H1N1 vaccination produced similar seroprotection rates in patients with mixed connective tissue disease compared to healthy controls (75.4% vs. 71.0%; p=0.7).
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