5 research outputs found
Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT).
Herpes zoster (HZ) can have a substantial impact on quality of life (QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on patients' QoL. Autologous HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1 month, and 1 year postdose 2 and during suspected HZ episodes with the Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of illness and burden of interference scores was estimated. The 2 scores were calculated from the area under the curve (days 0 to 182) of the ZBPI worst pain and ZBPI activities of daily living scores, respectively, assuming a score of 0 for patients not having a confirmed HZ episode. The ZBPI maximum worst pain score was significantly lower in the RZV than placebo group (mean: 5.8 versus 7.1, P = .011). Consequently, the VE estimates for HZ burden of illness (82.5%; 95% CI, 73.6 to 91.4) and burden of interference (82.8%; 95% CI, 73.3 to 92.3) were higher than the HZ VE estimate (ie, 68.2%). RZV showed significantly better QoL scores than placebo 1 week following rash onset among patients with confirmed HZ. In addition to reducing the risk of HZ and its complications, RZV significantly reduced the impact of HZ on patients' QoL in those who developed breakthrough disease
Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT)
Herpes zoster (HZ) can have a substantial impact on quality of life
(QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV)
was 68.2\% (95\% confidence interval {[}CI], 55.6\% to 77.5\%) in a
phase 3 study in adult autologous hematopoietic stem cell transplant
(HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on
patients' QoL. Autologous HSCT recipients were randomized 1:1 to receive
2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured
by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1
month, and 1 year postdose 2 and during suspected HZ episodes with the
Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of
illness and burden of interference scores was estimated. The 2 scores
were calculated from the area under the curve (days 0 to 182) of the
ZBPI worst pain and ZBPI activities of daily living scores,
respectively, assuming a score of 0 for patients not having a confirmed
HZ episode. The ZBPI maximum worst pain score was significantly lower in
the RZV than placebo group (mean: 5.8 versus 7.1, P = .011).
Consequently, the VE estimates for HZ burden of illness (82.5\%; 95\%
CI, 73.6 to 91.4) and burden of interference (82.8\%; 95\% CI, 73.3 to
92.3) were higher than the HZ VE estimate (ie, 68.2\%). RZV showed
significantly better QoL scores than placebo 1 week following rash onset
among patients with confirmed HZ. In addition to reducing the risk of HZ
and its complications, RZV significantly reduced the impact of HZ on
patients' QoL in those who developed breakthrough disease. (C) 2019
American Society for Transplantation and Cellular Therapy. Published by
Elsevier Inc
Effect of recombinant zoster vaccine on incidence of Herpes zoster after autologous stem cell transplantation : a randomized clinical trial
IMPORTANCE Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster.
OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients.
DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT.
INTERVENTIONS Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n=922) or placebo (n=924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter.
MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster cases.
RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P<.001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P=.02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P=.02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P=.01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points.
CONCLUSIONS AND RELEVANCE Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0161041
Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial
IMPORTANCE Herpes zoster, a frequent complication following autologous
hematopoietic stem cell transplantation (HSCT), is associated with
significant morbidity. A nonlive adjuvanted recombinant zoster vaccine
has been developed to prevent posttransplantation zoster.
OBJECTIVE To assess the efficacy and adverse event profile of the
recombinant zoster vaccine in immunocompromised autologous HSCT
recipients.
DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded
study conducted in 167 centers in 28 countries between July 13, 2012,
and February 1, 2017, among 1846 patients aged 18 years or older who had
undergone recent autologous HSCT.
INTERVENTIONS Participants were randomized to receive 2 doses of either
recombinant zoster vaccine (n=922) or placebo (n=924) administered into
the deltoid muscle; the first dose was given 50 to 70 days after
transplantation and the second dose 1 to 2 months thereafter.
MAIN OUTCOMES AND MEASURES The primary end point was occurrence of
confirmed herpes zoster cases.
RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688
[37%] women) who received 1 vaccine or placebo dose, 1735 (94%)
received a second dose and 1366 (74%) completed the study. During the
21-month median follow-up, at least 1 herpes zoster episode was
confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94
per 1000 person-years, respectively), an incidence rate ratio (IRR) of
0.32 (95% CI, 0.22-0.44; P<.001), equivalent to 68.2% vaccine
efficacy. Of 8 secondary end points, 3 showed significant reductions in
incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR,
0.1; 95% CI, 0.00-0.78; P=.02) and of other prespecified herpes
zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22;
95% CI, 0.04-0.81; P=.02) and in duration of severe worst herpes
zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days;
hazard ratio, 0.62; 95% CI, 0.42-0.89; P=.01). Five secondary
objectives were descriptive. Injection site reactions were recorded in
86% of vaccine and 10% of placebo recipients, of which pain was the
most common, occurring in 84% of vaccine recipients (grade 3: 11%).
Unsolicited and serious adverse events, potentially immune-mediated
diseases, and underlying disease relapses were similar between groups at
all time points.
CONCLUSIONS AND RELEVANCE Among adults who had undergone autologous
HSCT, a 2-dose course of recombinant zoster vaccine compared with
placebo significantly reduced the incidence of herpes zoster over a
median follow-up of 21 months.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0161041
Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial
IMPORTANCE Herpes zoster, a frequent complication following autologous
hematopoietic stem cell transplantation (HSCT), is associated with
significant morbidity. A nonlive adjuvanted recombinant zoster vaccine
has been developed to prevent posttransplantation zoster.
OBJECTIVE To assess the efficacy and adverse event profile of the
recombinant zoster vaccine in immunocompromised autologous HSCT
recipients.
DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, observer-blinded
study conducted in 167 centers in 28 countries between July 13, 2012,
and February 1, 2017, among 1846 patients aged 18 years or older who had
undergone recent autologous HSCT.
INTERVENTIONS Participants were randomized to receive 2 doses of either
recombinant zoster vaccine (n=922) or placebo (n=924) administered into
the deltoid muscle; the first dose was given 50 to 70 days after
transplantation and the second dose 1 to 2 months thereafter.
MAIN OUTCOMES AND MEASURES The primary end point was occurrence of
confirmed herpes zoster cases.
RESULTS Among 1846 autologous HSCT recipients (mean age, 55 years; 688
{[}37\%] women) who received 1 vaccine or placebo dose, 1735 (94\%)
received a second dose and 1366 (74\%) completed the study. During the
21-month median follow-up, at least 1 herpes zoster episode was
confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94
per 1000 person-years, respectively), an incidence rate ratio (IRR) of
0.32 (95\% CI, 0.22-0.44; P<.001), equivalent to 68.2\% vaccine
efficacy. Of 8 secondary end points, 3 showed significant reductions in
incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR,
0.1; 95\% CI, 0.00-0.78; P=.02) and of other prespecified herpes
zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22;
95\% CI, 0.04-0.81; P=.02) and in duration of severe worst herpes
zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days;
hazard ratio, 0.62; 95\% CI, 0.42-0.89; P=.01). Five secondary
objectives were descriptive. Injection site reactions were recorded in
86\% of vaccine and 10\% of placebo recipients, of which pain was the
most common, occurring in 84\% of vaccine recipients (grade 3: 11\%).
Unsolicited and serious adverse events, potentially immune-mediated
diseases, and underlying disease relapses were similar between groups at
all time points.
CONCLUSIONS AND RELEVANCE Among adults who had undergone autologous
HSCT, a 2-dose course of recombinant zoster vaccine compared with
placebo significantly reduced the incidence of herpes zoster over a
median follow-up of 21 months.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0161041