Table 2 Ebola glycoprotein-specific antibody concentrations (in log10 ELISA units/mL) in each trial from 7 days after the second vaccination to study completion.

From: Prediction of long-term humoral response induced by the two-dose heterologous Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola

 

Phase I trials

Phase II trials

 

EBL1001

EBL1003

EBL1004

EBL2001

EBL2002

EBL3001

 

(n = 14)a

(n = 15)a

(n = 15)a

(n = 71)a

(n = 137)b

(n = 235)c

Day 64 (7 days after the 2nd vaccination, MVA-BN-Filo)

Number Part.

14

15

15

   

Positive Part.d

14 (100%)

15 (100%)

15 (100%)

   

Missing data

0 (0%)

0 (0%)

0 (0%)

   

Mean [IQR]

3.19 [2.99; 3.48]

3.33 [2.90; 3.73]

3.09 [2.55; 3.58]

   

Day 78 (21 days after the 2nd vaccination, MVA-BN-Filo)

Number Part.

14

15

15

70

137

231

Positive Part.d

14 (100%)

15 (100%)

15 (100%)

70 (100%)

137 (100%)

231 (100%)

Missing data

0 (0%)

0 (0%)

0 (0%)

1 (1%)

0 (0%)

4 (2%)

Mean [IQR]

3.88 [3.64; 4.10]

4.21 [3.96; 4.45]

4.03 [3.80; 4.31]

4.00 [3.79; 4.43]

3.88 [3.62; 4.16]

3.60 [3.34; 3.88]

Day 156 (155 days after the 1st vaccination, Ad26.ZEBOV)

Number Part.

     

42e

Positive Part.d

     

42 (100%)

Missing data

     

1 (2%)

Mean [IQR]

     

2.73 [2.54; 3.00]

Day 180 (179 days after the 1st vaccination, Ad26.ZEBOV)

Number Part.

12

15

15

 

23f

 

Positive Part.d

12 (100%)

15 (100%)

15 (100%)

 

23 (100%)

 

Missing data

2 (14%)

0 (0%)

0 (0%)

   

Mean [IQR]

3.47 [3.29; 3.60]

3.00 [2.67; 3.20]

2.97 [2.71; 3.25]

 

2.70 [2.47; 2.85]

 

Day 240 (239 days after the 1st vaccination, Ad26.ZEBOV)

Number Part.

13

15

15

   

Positive Part.d

13 (100%)

15 (100%)

15 (100%)

   

Missing data

1 (7%)

0 (0%)

0 (0%)

   

Mean [IQR]

3.35 [3.20; 3.41]

2.66 [2.22; 2.93]

2.83 [2.56; 3.09]

   

Day 360/365 (1 year after the 1st vaccination, Ad26.ZEBOV)

Number Part.

12

15

15

51

134

207

Positive Part.d

12 (100%)

15 (100%)

15 (100%)

51 (100%)

134 (100%)

205 (99%)

Missing data

2 (14%)

0 (0%)

0 (0%)

20 (28%)

3 (2%)

28 (12%)

Mean [IQR]

3.24 [3.09; 3.33]

2.61 [2.40; 2.96]

2.74 [2.46; 3.06]

3.07 [2.89; 3.28]

2.54 [2.26; 2.78]

2.44 [2.11; 2.68]

Day 540 (539 days after the 1st vaccination, Ad26.ZEBOV)

Number Part.

     

33e

Positive Part.d

     

33 (100%)

Missing data

     

10 (23%)

Mean [IQR]

     

2.43 [2.15; 2.68]

Day 720 (2 years after the 1st vaccination, Ad26.ZEBOV)

Number Part.

     

190

Positive Part.d

     

184 (97%)

Missing data

     

45 (19 %)

Mean [IQR]

     

2.45 [2.19; 2.69]

  1. IQR: Interquartile range = 75% confidence intervals, Part.: Participants.
  2. aParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 1 day.
  3. bParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 3 days.
  4. cParticipants receiving the 2nd vaccination in the protocol-defined window of 57 ± 1 week.
  5. dRefers to the number of participants with antibody concentration above the lower limit of quantification (LLOQ), expressed as n/N (%) where n is the number of participants with a concentration above the LLOQ (i.e., 36.11 EU/mL for Battelle lab, 26.22 EU/mL for Focus lab and 36.11 EU/mL for Q2 Solutions lab) at that timepoint and N is the total number of participants with data at the first and the second vaccination and at that time point.
  6. eRefers only to 43 participants enrolled in a substudy to receive a third dose (Ad26.ZEBOV) 2 years after the first vaccination.
  7. fRefers to participants enrolled in EBL 2002 having an additional timepoint, initially scheduled for participants who do not receive a second vaccination because of a study pause.
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