Table 1.
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