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news.SciClone and its partner, Sigma-Tau have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis.
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According to the company, Zadaxin treatment given with the H1N1 vaccine led to a significant (p value < 0.01) increase in the percentage of subjects who seroconverted at 21 days after vaccination, when compared to those who received the H1N1 vaccine alone.
The randomized, three-arm open label study has a planned duration of six months and hence is still ongoing. It is being conducted in patients with end-stage renal disease who are on chronic dialysis. One cohort of patients received the H1N1 vaccine only, while the other two groups received either two 3.2mg injections of thymalfasin (one seven days prior to vaccination and the second on the day of vaccination with Focetria), or two 6.4mg injections of thymalfasin (one seven days prior to vaccination and the second on the day of vaccination with Focetria). Dosing regimens were based on preclinical results obtained in ferret and mouse models conducted in Europe and the US earlier this year.
The ongoing study is designed to evaluate efficacy based on the proportion of patients achieving seroconversion – a significant rise in specific antibody titers against H1N1 influenza. According to investigators, at 21 days following vaccination, 89% of patients in the low-dose Zadaxin arm achieved seroconversion as did 88% of patients in the high-dose Zadaxin arm, compared to only 56% of patients in the vaccine-only arm of the study. All patients are being followed for six months, to measure the durability of the protective titers, the second key parameter for the assessment of the immunogenicity of a vaccination. A higher seroconversion rate is indicative of the robustness of the immune response and may lead to more durable protection.
Trevor Jones, group R&D director at Sigma-Tau, said: “We believe the rapid achievement of full enrollment in this study indicates the need for safe and effective vaccine enhancers to help protect immune compromised and elderly patients from H1N1 influenza. Given the complexities in treating those with compromised or weakened immune systems, we believe these are the patients most in need of protection from life-threatening virus infections such as H1N1.”