Table 2.
Outcomes, by Assigned Treatment Group and Treatment Group Differences (95% Confidence Intervals)
| Outcomes | Triplex Group (N=51) |
Placebo Group (N=51) |
Hazard Ratio or Risk Difference (95% Cl) |
P Value |
|---|---|---|---|---|
| Primary Outcomes | ||||
| Non-relapse mortality at 100 days post-HCT– no. pts. (%) | 0 (0) | 2(3.9) | RD: −3.9 (−11, 3.4) | 0.50 |
| Severe (grade 3-4) acute GVHD – no. pts. (%) | 8(15.7) | 4(7.8) | RD: 7.8 (−6.5, 22) | 0.23 |
| Grade 3-4 adverse events1 – no. pts. (%) | 0 (0) | 1 (2.0) | RD: −2.0 (−7.7, 3.8) | 1.0 |
| CMV events2 through day 100 post-HCT – no. pts. (%) | 5 (9.8) | 10 (19.6) | HR: 0.46 (0.16, 1.4) | 0.075 |
| Secondary Outcomes | ||||
| Any CMV event from injection to study end – no. pts. (%) | 10 (19.6) | 14 (27.5) | HR: 0.63 (0.28, 1.4) | 0.26 |
| Recurrence of CMV events through study end3 – no. events | 21 | 17 | HR: 1.2 (0.64,2.28) | 0.57 |
| Duration of viremia4 – mean days (range) | 11.8 (0, 154) | 7.8 (0, 75) | NA | 0.49 |
| Use of antivirals – no. pts. (%) | 10(19.6) | 13 (25.5) | RD −5.9 (−24, 12) | 0.64 |
| Grade 2-4 acute GVHD – no. pts. (%) | 16 (31.4) | 15 (29.4) | HR 1.05 (0.52, 2.13) | 0.88 |
| Chronic GVHD - no. pts. (%) | 23 (45.1) | 26 (51.0) | RD −5.9 (−27, 15) | 0.27 |
| Relapse – no. pts. (%) | 11 (21.6) | 8 (15.7) | HR 1.36 (0.55, 3.38) | 0.51 |
| Non-relapse mortality – no. pts. (%) | 4 (7.8) | 5 (9.8) | HR 0.80 (0.22,2.93) | 0.73 |
| All-cause mortality – no. pts. (%) | 8 (15.7) | 8 (15.7) | HR 0.96 (0.36,2.56) | 0.93 |
| Infections – no. pts. (%) | 7 (13.7) | 7 (13.7) | RD 0 (−13, 13) | 1.0 |
| Grade 3-4 adverse events5 – no. pts. (%) | 2(3.9) | 4 (7.8) | RD −3.9 (−7.1, 15) | 0.68 |
| Cellular immunity (see Figure 3) | ||||
Based on Common Terminology Criteria for Adverse Events (CTCAE, v4.3), at least probably or definitely related (detail are found in Table S2) to vaccination within 2 weeks from first and second injection
CMV reactivation >1250 CMV DNA IU/mL; CMV viremia prompting antiviral therapy, or CMV disease prior to day 100 post-HCT
Andersen-Gill method (30) was used to compare hazard of initial and recurrent CMV events in patients receiving Triplex or placebo over the entire study period
Medians are zero, p-value from rank-sum test
AEs (CTCAE, version 4.3) at least possibly related to vaccination (details are found in Table S2) within 2 weeks from first and second injection; RD denotes Risk Difference, GVHD graft-versus-host disease, HR hazard ratio, pts. Patients, NA not applicable.