HSCT (haematopoietic stem cell transplantation) is an intense chemotherapy treatment for MS. It aims to stop the damage MS causes by wiping out and then regrowing your immune system, using your stem cells.
Day 0: Stem Cell and New Birthday. Worth Fighting for.
HSCT aims to 'reset' the immune system to stop it attacking the central nervous system. It uses chemotherapy to remove the harmful immune cells and then rebuilds the immune system using a type of stem cell found in your bone marrow. These are the haematopoietic stem cells.
In April, his wife and mother urged him to go to the emergency room for blood work and a CT scan. The results showed stage 4 mantle cell lymphoma, a rare type of non-Hodgkin lymphoma that affects the lymphatic system.
Aetna considers re-vaccination with recombinant herpes zoster vaccine (Shingrix) medically necessary for hematopoietic stem-cell transplant (HSCT) recipients if 24 months have passed since HSCT, the recipient does not have graft-versus-host disease, and member is considered immunocompetent.
Mullane et al (2013) conducted a randomized, double-blind, placebo-controlled, multi-center study on the safety and immunogenicity of heat-treated zoster vaccine (ZVHT). Four doses of ZVHT or placebo were administered approximately 30 days apart to adults with either solid tumor malignancy (STM); hematologic malignancy (HM); human immunodeficiency virus (HIV) with CD4(+)
Lal and associates (2015) stated that in previous phase I and phase II clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. These researchers performed a randomized, placebo-controlled, phase III clinical trial in 18 countries to examine the safety and effectiveness of HZ/su in older adults (greater than or equal to 50 years of age), stratified according to age group (50 to 59, 60 to 69, and greater than or equal to 70 years). Participants received 2 intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to evaluate the effectiveness of the vaccine, as compared with placebo, in reducing the risk of HZ in older adults. A total of 15,411 participants who could be evaluated received either the vaccine (7,698 participants) or placebo (7,713 participants). During a mean follow-up of 3.2 years, HZ was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 versus 9.1 per 1,000 person-years) in the modified vaccinated cohort. Overall vaccine effectiveness against HZ was 97.2 % (95 % CI: 93.7 to 99.0; p
Cunningham and colleagues (2016) noted that a trial involving adults 50 years of age or older (ZOE-50) showed that the HZ subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2 % lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and effectiveness of HZ/su in adults 70 years of age or older (ZOE-70). This randomized, placebo-controlled, phase III clinical trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received 2 doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine effectiveness against HZ and PHN was assessed in subjects from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. In ZOE-70, 13,900 participants who could be evaluated (mean age of 75.6 years) received either HZ/su (6,950 participants) or placebo (6,950 participants). During a mean follow-up period of 3.7 years, HZ occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 versus 9.2 per 1,000 person-years). Vaccine effectiveness against HZ was 89.8 % (95 % CI: 84.2 to 93.7; p
In a Cochrane review, Gagliardi and co-workers (2016) evaluated the safety and effectiveness of vaccination for preventing HZ in older adults. For this 2015 update, these investigators searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), Medline (1948 to the third week of October 2015), Embase (2010 to October 2015), CINAHL (1981 to October 2015) and LILACS (1982 to October 2015). Randomized controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent HZ in older adults (mean age greater than 60 years). Two review authors independently collected and analyzed data using a data extraction form. They also performed "Risk of bias" assessment. These researchers identified 13 studies involving 69,916 participants. The largest study included 38,546 participants. All studies were conducted in high-income countries and included only healthy Caucasian individuals greater than or equal to 60 years of age without immunosuppressive co-morbidities. A total of 10 studies used live attenuated varicella zoster virus (VZV) vaccines; 3 studies tested a new type of vaccine not yet available for clinical use. These researchers judged 5 of the included studies to be at low risk of bias. The incidence of HZ, at up to 3 years of follow-up, was lower in participants who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49; 95 % CI: 0.43 to 0.56, risk difference (RD) 2 %, number needed to treat to benefit (NNTB) 50; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of mild-to-moderate intensity AEs. These date came from 1 large study that included 38,546 people aged 60 years or older. A study including 8,122 participants compared the new vaccine (not yet available) to the placebo; the group that received the new vaccine had a lower incidence of HZ at 3.2 years of follow-up: RR 0.04, 95 % CI: 0.02 to 0.10, RD 3 %, NNTB 33; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of AEs; but most them were of mild-to-moderate intensity. The authors concluded that HZ vaccine is effective in preventing HZ disease and this protection can last 3 years. In general, zoster vaccine is well-tolerated; it produces few systemic AEs and injection site AEs of mild-to-moderate intensity. There are studies of a new vaccine (with a VZV glycoproteic fraction plus adjuvant), which is currently not yet available for clinical use.
Shingrix is a non-live, recombinant subunit vaccine that combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC, 2017) recommended the use of the new Shingrix vaccine (GlaxoSmithKline) over the existing Zostavax vaccine (Merck) for the prevention of shingles in immunocompetent adults 50 years of age and older. The Advisory Committee on Immunization Practices (ACIP) also recommended that adults who previously received Zostavax be given Shingrix. The previous ACIP recommendation applied to adults 60 years of age and older.The FDA approved Shingrix (zoster vaccine recombinant, adjuvanted) on October 20, 2017 for the prevention of herpes zoster (shingles) in adults aged 50 years and older. The approval was based on a comprehensive phase 3 clinical trial program involving 38,000 adults to evaluate the vaccine's efficacy, safety, and immunogenicity.In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of four years. By preventing shingles, Shingrix also reduced the overall incidence of post-herpetic neuralgia (PHN), The Prescribing Information for Shingrix states that it is not indicated for the prevention of primary varicella infection (chickenpox). It is contraindicated in persons with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix. 2ff7e9595c
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