Table 1 Summary of demographic and baseline characteristics by stage and vaccination arm

From: Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

 

Stage 1: mRNA-1273 (50 µg)

Enrollment 30 March–6 May 2022

Stage 2: BNT162b2 (30 µg)

Enrollment 12–27 May 2022

Stage 3: pre-S DTM ASO3 (5 µg)

Enrollment 8–17 June 2022

Arm 1: 1 dose prototype (n = 99)

Arm 2: 1 dose Beta + Omicron BA.1 (n = 100)

Arm 3: 2 dose Beta + Omicron BA.1 (n = 102)

Arm 4: 1 dose Delta + Omicron BA.1 (n = 101)

Arm 5: 1 dose Omicron BA.1 (n = 100)

Arm 6: 1 dose Omicron BA.1 + prototype (n = 100)

Total (n = 602)

Arm 7: 1 dose wild type (n = 51)

Arm 8: 1 dose Beta + Omicron BA.1 (n = 52)

Arm 9: 1 dose Omicron BA.1 (n = 54)

Arm 10: 1 dose Beta (n = 51)

Arm 11: 1 dose Beta + wild type (n = 52)

Arm 12: 1 dose Omicron BA.1 + wild type (n = 53)

Total (n = 313)

Arm 13: 1 dose prototype (n = 49)

Arm 14: 1 dose Beta (n = 51)

Arm 15: 1 dose Beta + wild type (n = 53)

Total (n = 153)

Age

 Median age, yr (range)

55 (22–79)

54.5 (19–81)

53.5 (24–80)

53 (19–76)

51 (21–85)

52.5 (18–78)

53 (18–85)

49 (22–76)

47 (20–81)

45 (21–83)

52 (22–77)

41.5 (25–81)

48 (20–82)

47 (20–83)

38 (18–76)

47 (26–79)

43 (19–79)

45 (18–79)

 18–64 years, n (%)

64 (65)

65 (65)

66 (65)

65 (64)

65 (65)

66 (66)

391 (65)

36 (71)

36 (69)

38 (70)

36 (71)

35 (67)

38 (72)

219 (70)

39 (80)

40 (78)

43 (81)

122 (80)

 ≥65 years, n (%)

35 (35)

35 (35)

36 (35)

36 (36)

35 (35)

34 (34)

211 (35)

15 (29)

16 (31)

16 (30)

15 (29)

17 (33)

15 (28)

94 (30)

10 (20)

11 (22)

10 (19)

31 (20)

Sex, n (%)

 Men

49 (49)

43 (43)

45 (44)

49 (49)

46 (46)

51 (51)

283 (47)

27 (53)

25 (48)

24 (44)

23 (45)

24 (46)

22 (42)

145 (46)

16 (33)

21 (41)

26 (49)

63 (41)

 Women

50 (51)

57 (57)

57 (56)

52 (51)

54 (54)

49 (49)

319 (53)

24 (47)

27 (52)

30 (56)

28 (55)

28 (54)

31 (58)

168 (54)

33 (67)

30 (59)

27 (51)

90 (59)

Ethnicity, n (%)

 Not Hispanic or Latino

94 (95)

90 (90)

100 (98)

94 (93)

93 (93)

95 (95)

566 (94)

46 (90)

46 (88)

45 (83)

49 (96)

49 (94)

52 (98)

287 (92)

41 (84)

46 (90)

49 (92)

136 (89)

 Hispanic or Latino

5 (5)

10 (10)

2 (2)

7 (7)

7 (7)

5 (5)

36 (6)

4 (8)

6 (12)

9 (17)

2 (4)

3 (6)

1 (2)

25 (8)

8 (16)

5 (10)

4 (8)

17 (11)

 Not reported

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (2)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Race, n (%)

 American Indian or Alaska Native

0 (0)

2 (2)

0 (0)

0 (0)

0 (0)

0 (0)

2 (0)

1 (2)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (0)

0 (0)

0 (0)

0 (0)

0 (0)

 Asian

5 (5)

6 (6)

8 (8)

6 (6)

7 (7)

9 (9)

41 (7)

5 (10)

9 (17)

9 (17)

5 (10)

6 (12)

6 (11)

40 (13)

9 (18)

4 (8)

4 (8)

17 (11)

 Native Hawaiian or other Pacific Islander

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

 Black

12 (12)

8 (8)

6 (6)

6 (6)

4 (4)

10 (10)

46 (8)

6 (12)

2 (4)

3 (6)

5 (10)

5 (10)

2 (4)

23 (7)

3 (6)

9 (18)

4 (8)

16 (10)

 White

79 (80)

82 (82)

87 (85)

81 (80)

86 (86)

79 (79)

494 (82)

38 (75)

39 (75)

39 (72)

39 (76)

38 (73)

44 (83)

237 (76)

35 (71)

38 (75)

38 (72)

111 (73)

 Multiracial

2 (2)

1 (1)

1 (1)

8 (8)

2 (2)

1 (1)

15 (2)

1 (2)

2 (4)

3 (6)

2 (4)

3 (6)

1 (2)

12 (4)

0 (0)

0 (0)

6 (11)

6 (4)

 Unknown race

1 (1)

1 (1)

0 (0)

0 (0)

1 (1)

1 (1)

4 (1)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

2 (4)

0 (0)

1 (2)

3 (2)

History of prior infection, n (%)

 Self-report

15 (15)

14 (15)

15 (15)

15 (15)

15 (15)

15 (15)

89 (15)

11 (22)

12 (23)

13 (24)

12 (24)

12 (23)

13 (25)

73 (23)

15 (31)

15 (29)

15 (28)

45 (29)

 Positive nucleocapsid antibody

20 (20)

16 (16)

19 (19)

15 (15)

23 (23)

18 (18)

111 (18)

17 (33)

18 (35)

18 (33)

16 (31)

14 (27)

16 (30)

99 (32)

22 (45)

18 (35)

19 (36)

59 (39)

 Self-report or positive nucleocapsid antibody

21 (21)

18 (18)

21 (21)

17 (17)

23 (23)

20 (20)

120 (20)

17 (33)

18 (35)

18 (33)

18 (35)

15 (29)

18 (34)

104 (33)

22 (45)

20 (39)

20 (38)

62 (41)

Prior SARS-CoV-2 vaccination regimen, n (%)

 mRNA primary, mRNA boost

95 (96)

93 (95)

97 (95)

95 (94)

95 (96)

96 (97)

571 (95)

51 (100)

52 (100)

54 (100)

50 (98)

52 (100)

51 (96)

310 (99)

46 (94)

50 (98)

51 (96)

147 (96)

 Ad26 primary, mRNA boost

4 (4)

5 (5)

4 (4)

5 (5)

4 (4)

1 (1)

23 (4)

0 (0)

0 (0)

0 (0)

1 (2)

0 (0)

2 (4)

3 (1)

2 (4)

0 (0)

2 (4)

4 (3)

 Ad26 primary, Ad26 boost

0 (0)

0 (0)

1 (1)

1 (1)

0 (0)

2 (2)

4 (1)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (2)

1 (2)

0 (0)

2 (1)

Days since most recent known SARS-CoV-2 antigenic exposure, median days (range)

 Most recent COVID-19 vaccine

170.0 (113–333)

164.0 (112–244)

176.5 (120–239)

167.0 (114–258)

174.0 (114–261)

170.0 (114–238)

170.0 (112–333)

198.0 (125–262)

200.0 (110–284)

203.0 (106–333)

209.0 (131–269)

206.0 (139–276)

202.0 (115–267)

202.0 (106–333)

209.0 (123–295)

202.0 (79–253)

211.0 (108–359)

209.0 (79–359)

 Most recent self-reported COVID-19 infection

475.0 (118–719)

250.5 (117–675)

227.0 (116–770)

218.0 (119–744)

493.0 (115–773)

243.0 (110–760)

395.0 (110–773)

170.0 (122–641)

246.5 (116–873)

163.0 (130–526)

156.0 (113–531)

141.5 (121–782)

141.0 (117–732)

148.0 (113–873)

156.0 (123–723)

211.0 (130–461)

152.0 (117–817)

156.5 (117–817)

 Most recent COVID-19 vaccine or self-reported COVID-19 infection

164.0 (113–333)

162.0 (112–244)

173.5 (116–239)

165.0 (114–258)

172.0 (114–261)

169.0 (110–238)

168.0 (110–333)

192.0 (122–262)

193.0 (110–284)

194.5 (106–333)

201.0 (113–269)

199.5 (121–276)

202.0 (115–267)

198.0 (106–333)

199.0 (123–295)

188.0 (79–253)

201.0 (108–359)

197.0 (79–359)

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