BACKGROUND: The adjuvanted recombinant zoster vaccine (Shingrix) can prevent 
herpes zoster in older adults and autologous haemopoietic stem cell transplant 
recipients. We evaluated the safety and immunogenicity of this vaccine in adults 
with haematological malignancies receiving immunosuppressive cancer treatments.
METHODS: In this phase 3, randomised, observer-blind, placebo-controlled study, 
done at 77 centres worldwide, we randomly assigned (1:1) patients with 
haematological malignancies aged 18 years and older to receive two doses of the 
adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or 
after immunosuppressive cancer treatments, and stratified participants according 
to their underlying diseases. The co-primary objectives of the study were the 
evaluation of safety and reactogenicity of the adjuvanted recombinant zoster 
vaccine compared with placebo from the first vaccination up to 30 days after 
last vaccination in all participants; evaluation of the proportion of 
participants with a vaccine response in terms of anti-glycoprotein E humoral 
immune response to the adjuvanted recombinant zoster vaccine at month 2 in all 
participants, excluding those with non-Hodgkin B-cell lymphoma and chronic 
lymphocytic leukaemia; and evaluation of the anti-glycoprotein E humoral immune 
responses to the vaccine compared with placebo at month 2 in all participants, 
excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic 
leukaemia. We assessed immunogenicity in the per-protocol cohort for 
immunogenicity and safety in the total vaccinated cohort. The study is 
registered with ClinicalTrials.gov, number NCT01767467, and with the EU Clinical 
Trials Register, number 2012-003438-18.
FINDINGS: Between March 1, 2013, and Sept 10, 2015, we randomly assigned 286 
participants to adjuvanted recombinant zoster vaccine and 283 to placebo. 283 in 
the vaccine group and 279 in the placebo group were vaccinated. At month 2, 119 
(80·4%, 95% CI 73·1-86·5) of 148 participants had a humoral vaccine response to 
adjuvanted recombinant zoster vaccine, compared with one (0·8%, 0·0-4·2) of 130 
participants in the placebo group, and the adjusted geometric mean 
anti-glycoprotein E antibody concentration was 23 132·9 mIU/mL (95% CI 
16 642·8-32 153·9) in the vaccine group and 777·6 mIU/mL (702·8-860·3) in the 
placebo group (adjusted geometric mean ratio 29·75, 21·09-41·96; p<0·0001) in 
all patients, excluding those with non-Hodgkin B-cell lymphoma and chronic 
lymphocytic leukaemia. Humoral and cell-mediated immune responses persisted 
above baseline until month 13 in all strata and, as expected, vaccine was more 
reactogenic than placebo (within 7 days after vaccination pain was reported by 
221 [79·5%] of 278 vaccine group participants and 45 [16·4%] of 274 placebo 
group participants; fatigue was reported by 162 [58·3%] of 278 vaccine group 
participants and 102 [37·2%] of 274 placebo group participants). Incidences of 
unsolicited or serious adverse events, potential immune-mediated diseases, 
disease-related events, and fatal serious adverse events were similar between 
the groups.
INTERPRETATION: The immunocompromised adult population with haematological 
malignancies is at high risk for herpes zoster. The adjuvanted recombinant 
zoster vaccine, which is currently licensed in certain countries for adults aged 
50 years and older, is likely to benefit this population.
FUNDING: GlaxoSmithKline Biologicals SA.