Table 2.
Study design and patient population in clinical trials of RZV in immunocompromised populations.
| Autologous HSCT12,13 | HIV 14 | Solid tumor 16 | Hematological malignancy17,18 | Renal transplant 19 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study characteristics | ||||||||||
| Study design and trial registration number | Randomized, phase-3,
placebo-controlled NCT01610414 |
Randomized, phase-1/2,
placebo-controlled NCT01165203 |
Randomized, phase-2/3,
placebo-controlled NCT01798056 |
Randomized, phase-3,
placebo-controlled NCT01767467 |
Randomized, phase-3,
placebo-controlled NCT02058589 |
|||||
| Study location | 28 countries | Germany, USA, UK | Canada, Czech Republic, France, Republic of Korea, Spain, UK | 77 centers worldwide | Belgium, Canada, Czech Republic, Finland, Italy, Panama, Republic of Korea, Spain, Taiwan | |||||
| Age eligibility criterion | ⩾18 years | ⩾18 years | ⩾18 years | ⩾18 years | ⩾18 years | |||||
| Vaccination schedule | Two-dose schedule Dose 1: 50−70 days after transplant Dose 2: 1−2 months after Dose 1 |
Three-dose schedule at Months 0, 2, and 6 | Two-dose schedule Doses administered 1−2 months apart. First dose was given either prior to or at the start of the chemotherapy cycle. Second dose was given with a subsequent chemotherapy cycle. a |
Two-dose schedule Doses administered 1−2 months apart during or after full cancer therapy course b |
Two-dose schedule Dose 1: 4−18 months post-transplant Dose 2: 1−2 months after Dose 1 |
|||||
| Patient characteristics | RZV | Placebo | RZV | Placebo | RZV | Placebo | RZV | Placebo | RZV | Placebo |
| N | 922 | 924 | 74 | 49 | 117 | 115 | 283 | 279 | 132 | 132 |
| Mean age (years) | 54.8 | 55.1 | 46.6 | 45.1 | 57.1 | 58.5 | 56.8 | 57.8 | 52.3 | 52.4 |
| Percentage ⩾50 years | 75.1% | 75.2% | 37.8% | 30.6% | 73.5% | 73.9% | 73.9% | 73.8% | 63.6% | 62.9% |
| Percentage men | 62.9% | 62.6% | 93.2% | 95.9% | 40.2% | 40.0% | 59.7% | 59.1% | 71.2% | 68.9% |
HIV, human immunodeficiency virus; HSCT, hematopoietic stem cell transplant; N, number of participants in the total vaccinated cohort; RZV, recombinant zoster vaccine.
The total vaccinated cohort for safety included all participants with at least one documented dose.
Participants were stratified (4:1) according to the timing of the first RZV or placebo dose with respect to the start of the first (or occasionally second) cycle of a chemotherapy course: first vaccination 8−30 days before the start of a cycle (pre-chemotherapy groups) or first vaccination within 1 day of the start of a cycle (on-chemotherapy groups). Paticipants received their second vaccination with a subsequent chemotherapy cycle.
Participants were vaccinated during a cancer therapy course (each dose at least 10 days before and after any cancer therapy) or after the full cancer therapy course (first dose between 10 days and 6 months after therapy).