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Table 2 Percentage of participants with rSBA titers above the cut-off and GMTs (ACWY-TT and Men-PS groups)

From: Long-term immunogenicity and safety after a single dose of the quadrivalent meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine in adolescents and adults: 5-year follow-up of an open, randomized trial

Antibody

Estimate

Timing

ACWY-TT

Men-PS

   

N

Value (95 % CI)

N

Value (95 % CI)

MenA

% ≥1:8

Pre

30

6.7 (0.8, 22.1)

19

0 (0.0, 17.6)

Month 1

30

100 (88.4, 100)

19

100 (82.4, 100)

Year 1

30

93.3 (77.9, 99.2)

19

84.2 (60.4, 96.6)

Year 2

99

94.9 (88.6; 98.3)

98

91.8 (84.5; 96.4)

Year 4

312

86.5 (82.2; 90.1)

107

73.8 (64.4; 81.9)

Year 5

299

90.0 (86.0, 93.1)

105

74.3 (64.8, 82.3)

% ≥1:128

Pre

30

6.7 (0.8, 22.1)

19

0 (0.0, 17.6)

Month 1

30

100 (88.4, 100)

19

100 (82.4, 100)

Year 1

30

90.0 (73.5, 97.9)

19

78.9 (54.4, 93.9)

Year 2

99

92.9 (86.0; 97.1)

98

87.8 (79.6; 93.5)

Year 4

312

78.5 (73.5; 83.0)

107

61.7 (51.8; 70.9)

Year 5

299

86.3 (81.9, 90.0)

105

68.6 (58.8, 77.3)

GMT

Pre

30

2.7 (1.7, 4.3)

19

2.0 (2.0, 2.0)

Month 1

30

4231.2 (2730.7, 6556.2)

19

1463.2 (886.5, 2415.0)

Year 1

30

1066.9 (472.4, 2409.6)

19

218.0 (71.0, 669.6)

Year 2

99

807.1 (559.5; 1164.2)

98

385.8 (259.4; 573.9)

Year 4

312

278.6 (219.7; 353.2)

107

105.4 (67.6; 164.4)

Year 5

299

303.9 (248.2, 372.0)

105

103.6 (67.8, 158.3)

MenC

% ≥1:8

Pre

30

10.0 (2.1, 26.5)

18

0.0 (0.0, 18.5)

Month 1

30

100 (88.4, 100)

18

100 (81.5, 100)

Year 1

30

96.7 (82.8, 99.9)

17

94.1 (71.3, 99.9)

Year 2

100

98.0 (93.0; 99.8)

99

86.9 (78.6; 92.8)

Year 4

312

88.5 (84.4; 91.8)

107

84.1 (75.8; 90.5)

Year 5

299

79.3 (74.2, 83.7)

104

71.2 (61.4, 79.6)

% ≥1:128

Pre

30

3.3 (0.1, 17.2)

18

0.0 (0.0, 18.5)

Month 1

30

100 (88.4, 100)

18

100 (81.5, 100)

Year 1

30

83.3 (65.3, 94.4)

17

94.1 (71.3, 99.9)

Year 2

100

86.0 (77.6; 92.1)

99

79.8 (70.5; 87.2)

Year 4

312

81.4 (76.6; 85.6)

107

73.8 (64.4; 81.9)

Year 5

299

69.2 (63.7, 74.4)

104

65.4 (55.4, 74.4)

GMT

Pre

30

3.1 (1.7, 5.6)

18

2.0 (2.0, 2.0)

Month 1

30

6886.0 (4473.9, 10598.7)

18

8070.7 (4896.6, 13302.2)

Year 1

30

462.7 (239.2, 895.2)

17

1956.8 (731.8, 5232.7)

Year 2

100

304.4 (232.0; 399.5)

99

286.3 (181.8; 450.9)

Year 4

312

273.6 (220.6; 339.4)

107

315.0 (196.8; 504.1)

Year 5

299

114.0 (90.5, 143.5)

104

142.4 (85.3, 237.6)

MenW

% ≥1:8

Pre

30

3.3 (0.1, 17.2)

18

11.1 (1.4, 34.7)

Month 1

30

96.7 (82.8, 99.9)

17

76.5 (50.1, 93.2)

Year 1

30

93.3 (77.9, 99.2)

18

66.7 (41.0, 86.7)

Year 2

100

84.0 (75.3; 90.6)

100

24.0 (16.0; 33.6)

Year 4

312

74.0 (68.8; 78.8)

107

25.2 (17.3; 34.6)

Year 5

299

71.6 (66.1, 76.6)

105

24.8 (16.9, 34.1)

% ≥1:128

Pre

30

0.0 (0.0, 11.6)

18

5.6 (0.1, 27.3)

Month 1

30

96.7 (82.8, 99.9)

17

76.5 (50.1, 93.2)

Year 1

30

90.0 (73.5, 97.9)

18

61.1 (35.7, 82.7)

Year 2

100

80.0 (70.8; 87.3)

100

19.0 (11.8; 28.1)

Year 4

312

68.6 (63.1; 73.7)

107

20.6 (13.4; 29.5)

Year 5

299

64.9 (59.2, 70.3)

105

21.0 (13.6, 30.0)

GMT

Pre

30

2.1 (1.9, 2.5)

18

3.3 (1.6, 7.0)

Month 1

30

9571.6 (4649.0, 19706.4)

17

881.6 (150.8, 5154.0)

Year 1

30

1659.2 (728.5, 3778.7)

18

120.3 (23.6, 614.5)

Year 2

100

257.8 (161.8; 410.7)

100

6.5 (4.2; 10.0)

Year 4

312

175.1 (131.5; 233)

107

11.3 (7.8; 16.3)

Year 5

299

170.2 (124.7, 232.4)

105

11.7 (7.9, 17.1)

MenY

% ≥1:8

Pre

28

28.6 (13.2, 48.7)

11

9.1 (0.2, 41.3)

Month 1

27

100 (87.2, 100)

12

100 (73.5, 100)

Year 1

28

96.4 (81.7, 99.9)

12

50.0 (21.1, 78.9)

Year 2

100

86.0 (77.6; 92.1)

100

44.0 (34.1; 54.3)

Year 4

309

82.8 (78.2; 86.9)

107

43.9 (34.3; 53.9)

Year 5

299

84.3 (79.7, 88.2)

105

44.8 (35.0, 54.8)

% ≥1:128

Pre

28

17.9 (6.1, 36.9)

11

9.1 (0.2, 41.3)

Month 1

27

100 (87.2, 100)

12

100 (73.5, 100)

Year 1

28

89.3 (71.8, 97.7)

12

33.3 (9.9, 65.1)

Year 2

100

82.0 (73.1; 89.0)

100

36.0 (26.6; 46.2)

Year 4

309

78.6 (73.6; 83.1)

107

34.6 (25.6; 44.4)

Year 5

299

80.9 (76.0, 85.2)

105

41.9 (32.3, 51.9)

GMT

Pre

28

9.3 (3.5, 24.5)

11

3.4 (1.2, 9.7)

Month 1

27

3659.5 (2193.4, 6105.6)

12

2663.0 (1821.9, 3892.4)

Year 1

28

1157.7 (572.2, 2342.3)

12

22.3 (3.4, 146.2)

Year 2

100

367.1 (232.2; 580.2)

100

19.4 (11.4; 33.0)

Year 4

309

350.5 (268.9; 456.7)

107

26.0 (16.6; 40.7)

Year 5

299

306.0 (236.3, 396.3)

105

29.6 (18.7, 46.7)

  1. Percentage of participants with rSBA antibody titers ≥1:8 and ≥1:128 and geometric mean titers in the ACWY-TT and the Men-PS groups at pre-vaccination, Month 1 and Year 1 (subset of participants from the ATP cohort for persistence Year 2 with samples tested by rSBA at the PHE laboratory) and at Years 2 (ATP cohort for persistence Year 2), 4 (ATP cohort for persistence Year 4) and 5 (Total Cohort Year 5)
  2. ACWY-TT = group of participants who received one dose of MenACWY-TT at Month 0
  3. Men-PS = group of participants who received one dose of MenACWY-PS at Month 0
  4. ATP = according to protocol
  5. Pre = pre-vaccination; Month 1 = 1 month post-vaccination, Year 1, 2, 4 and 5 = 1, 2, 4 and 5 years post-vaccination
  6. N = number of participants with available results
  7. % = percentage of participants with titers within the specified range
  8. GMT = geometric mean titer
  9. 95 % CI = 95 % confidence interval
  10. Bold: 95 % CI on group difference or GMT ratio excluding equality between the ACWY-TT and Men-PS groups
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BMC Infectious Diseases

ISSN: 1471-2334

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