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. 2021 Jun 11;44(7):811–823. doi: 10.1007/s40264-021-01076-w

Table 1.

Study overview

Populations (study abbreviation) NCT number Phase First dose No. of doses (months)a Placebo TVCb References
RZV Placebo
18–49 ≥ 50 18–49 ≥ 50
Autologous hematopoietic cell transplant recipients (auto-HSCT[III]) NCT01610414 III After transplantation 2 (month 0, 2) Sucrose reconstituted with saline 230 692 229 695 [42]
Hematologic malignancies (HM) NCT01767467 III During or after therapy 2 (month 0, 2) Sucrose reconstituted with saline 74 209 73 206 [43]
Renal transplant recipients (RT) NCT02058589 III After therapy 2 (month 0, 2) Sucrose reconstituted with saline 48 84 49 83 [45]
Patients with solid tumors (ST) NCT01798056 II/III During or after therapy 2 (month 0, 2) Sucrose reconstituted with saline 31 86 30 85 [46]
Autologous hematopoietic cell transplant recipients (auto-HSCT[I/II]) NCT00920218 I/II After transplantation 2a (month 1, 3) Saline 4 25 [47]
3a (month 0, 1, 3) 10 20 4 26
HIV-infected participants (HIV) NCT01165203 I/II At study initiation 3 (month 0, 2, 6) Saline 46 28 34 15 [48]

HIV human immunodeficiency virus, RZV adjuvanted recombinant zoster vaccine, TVC total vaccinated cohort

aStudy participants in the auto-HSCT(III), RT, HM, and ST studies received two intramuscular doses of either RZV or saline placebo, with the second dose administered 1–2 months after the first vaccination. Participants in the auto-HSCT(I/II) study were stratified into four groups. One group received three doses of glycoprotein E/AS01E, and was not included in the analyses presented in this manuscript. The subgroups included in this manuscript received two doses of RZV (at months 1 and 3), three doses of RZV (at months 0, 1, and 3), or three doses of placebo (at months 0, 1, and 3). Participants in the HIV study received three doses of RZV or placebo at months 0, 2, and 6

bAll data are reported for the total vaccinated cohort consisting of all participants who received at least one dose of RZV or placebo