We live in times when it seems that some of its worst prophecies have been led to the extreme. In retrospect, the early SF literature may look outdated and naïve. Many of us have experienced, while letting ourselves be captured by SF novels, a thrill of wonder and displacement, the comfortable discomfort of dwelling for a while in some of these weird worlds. More recently, science fiction has channeled our longing for infinity into a flowering of possible worlds, which can be in turn dramatic, grotesque, dystopic, prophetic, disturbing or consolatory. Preliminary data suggests that RZV induces humoral immune responses in patients with CLL.Since modern science replaced the certainties of ancient theology with systematic doubt, human imagination has been pushed to venture through the gates of an unknown universe. Compared to previously reported toxicities in the healthy population, no increase in frequency or severity of AEs were observed. RZV administration appears to be safe in CLL patients that are treatment naïve or receiving treatment with a BTK-I. Preliminary analysis of 3-month samples (n = 43) shows early evidence of increasing titers after the first dose of RZV. All patients (n = 7) achieved ≥ 2.2-fold rise in VZV anti-gE titers at 6-months. Serologic responses were observed in 3 (43%) patients. Seven subjects have completed the primary endpoint and have had serologic response assessment at 6-months. All AEs resolved or returned to baseline within 7 days of vaccine administration. All adverse reactions were grade 1-2, except for 2 (4%) grade 3 reactions. The most frequent local and systemic AEs were injection site pain (67%), injection site reaction (32%) and generalized myalgias (25%) (Table 1). Safety data are available on 57 subjects who received at least one vaccine dose. The data reported herein are as of July 12 th 2019 updated results will be presented at the meeting. All subjects completed an adverse event (AE) diary documenting any local (injection site) or systemic AE that started within 7 days after receiving the first and second vaccine dose. Additionally, serologic response was analyzed 3 months following the first vaccine administration to study the kinetics of the humoral vaccine response. Based on results of prior published studies, serologic response was defined as a ≥ four-fold rise in VZV anti-glycoprotein E (anti-gE) blood IgG serum titer after completing the RZV vaccine series. Subjects were followed for 6 months and received assessment of serologic response at 3- and 6-months. In this phase II open-label study (NCT03702231), patients with CLL who were either treatment naïve or receiving treatment with a Bruton's tyrosine kinase inhibitor (BTK-I) (ibrutinib or acalabrutinib) received 2 doses of RZV via intramuscular injection at 0- and 3-months. We report preliminary safety and efficacy of RZV in treated and untreated CLL patients. RZV is proven to reduce the risks of herpes zoster and postherpetic neuralgia in healthy adults ≥ 50 years of age, however its efficacy in immunocompromised individuals, including CLL, remains unknown. A new recombinant (non-live) adjuvanted shingles vaccine (SHINGRIX RZV) has the potential to reduce VZV reactivation, without the risk of giving a live vaccine to immunocompromised individuals. Patients with CLL are at increased risk of developing varicella zoster virus (VZV) reactivation (shingles) due to their advanced age and immunocompromised status. Immune dysregulation is a hallmark of CLL, making these patients particularly vulnerable to infectious complications.
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