Table 3.
Vaccine Respondersa by Group and CMV Serostatus
| Response | Group 1 1 mg at 0, 2, and 8 weeks |
Group 2 5 mg at 0, 2, and 8 weeks |
Group 3 5 mg at 0, 3, 7, 28 days |
|||
|---|---|---|---|---|---|---|
| Seronegative (N= 8) N (%) |
Seropositive (N= 8) N (%) |
Seronegative (N= 8) N (%) |
Seropositive (N= 8) N (%) |
Seronegative (N= 6) N (%) |
Seropositive (N= 6) N (%) |
|
| gB antibody | 2 (25.0) |
0 (0.0) |
2 (25.0) |
0 (0.0) |
1 (16.7) |
0 (0.0) |
| pp65 ex vivo IFN-γ ELISPOT |
2 (25.0) |
3 ( 37.5) |
3 (37.5) |
1 (12.5) |
3 (50.0) |
1 (16.7) |
| gB ex vivo IFN-γ ELISPOT |
n.d.b | n.d. | 2 (25) |
n.d. | 2 (33) |
n.d. |
| Total | 3 (37.5) |
3 (37.5) |
4 (50.0) |
1 (12.5) |
3 (50.0) |
1 (16.7) |
Subjects with a vaccine induced antibody or T-cell response prior to or at Week 16 (Day 112) are reported Antibody responders to the cytomegalovirus (CMV) glycoprotein B (gB) are those with sera that were negative in the gB ELISA prior to vaccination and positive in the assay after vaccination or, those with sera that were positive in the assay at baseline, and had a postvaccine increase in gB antibody levels of >4-fold relative to baseline.
Ex vivo gamma interferon (IFN-γ) ELISPOT assay responders to the CMV phosphoprotein 65 (pp65) or gB are those with negative results in the ex vivo IFN-γ ELISPOT assay prior to vaccination and positive results in the assay after vaccination or those with positive results in the ex vivo IFN-γ ELISPOT assay prior to vaccination and a postvaccine increase in pp65 specific IFN-γ secreting T cells of >2.4-fold.
not done