The effectiveness of PENBRAYA was assessed in Study 1 by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA). For serogroups A, C, W, and Y, one strain was utilized per group. For serogroup B, four meningococcal serogroup B strains expressing different fHbp variants that represent the A and B subfamilies of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe were utilized. The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed.
Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received PENBRAYA at 0 and 6 months or Trumenba at 0 and 6 months and MenACWY-CRM at 0 months. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine -naïve and MenACWY conjugate vaccine-exposed participants were part of the study.
Seroresponse for serogroups A, B, C, W, and Y and composite response for serogroup B following 2 doses of PENBRAYA in Study 1 are presented in Tables 3 and 4.
Among both ACWY-naïve and ACWY-exposed participants, seroresponse rates to serogroups A, C, W, and Y following 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse rates following a single dose of MenACWY-CRM. Seroresponse and composite response rates to serogroup B primary strains among participants who received 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse and composite response rates following 2 doses of Trumenba.
| Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. | |||
| Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. | |||
| Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer. | |||
Serogroup | PENBRAYA % | Trumenba + MenACWY-CRM % | PENBRAYA – MenACWY-CRM Difference‡ |
N=439-451 (Naïve) N=376-387 (Exposed) | N=244-254 (Naïve) N=222-227 (Exposed) | Difference % (95% CI) | |
A | |||
ACWY-naïve | 97.8 | 95.3 | 2.5 (-0.2, 6.0) |
ACWY-exposed | 93.8 | 96.9 | -3.2 (-6.5, 0.5) |
C | |||
ACWY-naïve | 93.3 | 52.4 | 41.0 (34.4, 47.5) |
ACWY-exposed | 93.8 | 94.7 | -0.9 (-4.6, 3.3) |
W | |||
ACWY- naïve | 97.3 | 73.0 | 24.3 (18.8, 30.4) |
ACWY-exposed | 97.1 | 96.4 | 0.7 (-2.2, 4.3) |
Y | |||
ACWY- naïve | 94.4 | 70.6 | 23.8 (18.0, 30.1) |
ACWY-exposed | 93.0 | 93.7 | -0.7 (-4.6, 3.8) |
| Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. | |||
| Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. | |||
| Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer. | |||
PENBRAYA % | Trumenba + MenACWY-CRM % | PENBRAYA – Trumenba Difference | |
Serogroup B Variant | N=755-845 | N=383-419 | Difference % (95% CI) |
Seroresponse‡ | |||
A22 | 83.0 | 79.0 | 4.0 (-0.7, 8.9) |
A56 | 95.9 | 94.5 | 1.4 (-1.0, 4.3) |
B24 | 68.1 | 57.2 | 10.9 (5.2, 16.6) |
B44 | 86.5 | 79.2 | 7.3 (2.9, 11.9) |
Composite§ | |||
Pre-Dose 1 | 1.2 | 2.0 | - |
Post-Dose 2 | 78.3 | 68.7 | 9.6 (4.2, 15.2) |
The effectiveness of PENBRAYA was assessed in Study 1 by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA). For serogroups A, C, W, and Y, one strain was utilized per group. For serogroup B, four meningococcal serogroup B strains expressing different fHbp variants that represent the A and B subfamilies of meningococcal serogroup B strains causing invasive disease in the U.S. and Europe were utilized. The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed.
Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received PENBRAYA at 0 and 6 months or Trumenba at 0 and 6 months and MenACWY-CRM at 0 months. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine -naïve and MenACWY conjugate vaccine-exposed participants were part of the study.
Seroresponse for serogroups A, B, C, W, and Y and composite response for serogroup B following 2 doses of PENBRAYA in Study 1 are presented in Tables 3 and 4.
Among both ACWY-naïve and ACWY-exposed participants, seroresponse rates to serogroups A, C, W, and Y following 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse rates following a single dose of MenACWY-CRM. Seroresponse and composite response rates to serogroup B primary strains among participants who received 2 doses of PENBRAYA were demonstrated to be non-inferior to seroresponse and composite response rates following 2 doses of Trumenba.
| Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. | |||
| Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. | |||
| Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer. | |||
Serogroup | PENBRAYA % | Trumenba + MenACWY-CRM % | PENBRAYA – MenACWY-CRM Difference‡ |
N=439-451 (Naïve) N=376-387 (Exposed) | N=244-254 (Naïve) N=222-227 (Exposed) | Difference % (95% CI) | |
A | |||
ACWY-naïve | 97.8 | 95.3 | 2.5 (-0.2, 6.0) |
ACWY-exposed | 93.8 | 96.9 | -3.2 (-6.5, 0.5) |
C | |||
ACWY-naïve | 93.3 | 52.4 | 41.0 (34.4, 47.5) |
ACWY-exposed | 93.8 | 94.7 | -0.9 (-4.6, 3.3) |
W | |||
ACWY- naïve | 97.3 | 73.0 | 24.3 (18.8, 30.4) |
ACWY-exposed | 97.1 | 96.4 | 0.7 (-2.2, 4.3) |
Y | |||
ACWY- naïve | 94.4 | 70.6 | 23.8 (18.0, 30.1) |
ACWY-exposed | 93.0 | 93.7 | -0.7 (-4.6, 3.8) |
| Abbreviations: CI = confidence interval; hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of quantitation; LOD = limit of detection; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine; Trumenba= meningococcal serogroup B factor H binding protein. | |||
| Note: The LLOQ is an hSBA titer = 1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. | |||
| Note: Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥ LOD and < LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥ LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer. | |||
PENBRAYA % | Trumenba + MenACWY-CRM % | PENBRAYA – Trumenba Difference | |
Serogroup B Variant | N=755-845 | N=383-419 | Difference % (95% CI) |
Seroresponse‡ | |||
A22 | 83.0 | 79.0 | 4.0 (-0.7, 8.9) |
A56 | 95.9 | 94.5 | 1.4 (-1.0, 4.3) |
B24 | 68.1 | 57.2 | 10.9 (5.2, 16.6) |
B44 | 86.5 | 79.2 | 7.3 (2.9, 11.9) |
Composite§ | |||
Pre-Dose 1 | 1.2 | 2.0 | - |
Post-Dose 2 | 78.3 | 68.7 | 9.6 (4.2, 15.2) |
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