Table 2 Adverse events after doses 1 and 2 of ARCT-154 and placebo in phases 1, 2 and 3a combined, and phase 3b (Safety Set, as treated)

From: Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials

  

Phases 1, 2 and 3a

Phase 3b

N = first dose / second dose

ARCT-154 (N = 748a / 732)

Placebo (N = 253a / 245)

ARCT-154 (N = 8059 / 7867c)

Placebo (N = 8041b / 7822c)

Any solicited adverse event,d n (%)

Dose 1

670 (89.6)

136 (53.8)

4732 (59.7)

2768 (35.1)

Dose 2

582 (79.5)

104 (42.4)

3833 (49.8)

2006 (26.3)

Local reactions, n (%)

Dose 1

586 (78.3)

51 (20.2)

3474 (43.8)

858 (10.9)

Dose 2

452 (61.7)

28 (11.4)

2401 (31.2)

585 (7.7)

Systemic adverse events, n (%)

Dose 1

557 (74.5)

120 (47.4)

3816 (48.1)

2499 (31.7)

Dose 2

506 (69.1)

93 (38.0)

3214 (41.7)

1796 (23.5)

Any adverse event within 28 dayse

Dose 1

177 (23.7)

71 (28.1)

1125 (14.0)

1101 (13.7)

Dose 2

124 (16.9)

45 (18.4)

1096 (13.9)

1241 (15.9)

Related adverse event within 28 days, n (%)

Dose 1

27 (3.6)

11 (4.3)

202 (2.5)

184 (2.3)

Dose 2

19 (2.6)

5 (2.0)

130 (1.7)

107 (1.4)

Severe adverse event within 28 days, n (%)

Dose 1

1 (0.1)

0

10 (0.1)

18 (0.2)

Dose 2

0

0

13 (0.2)

17 (0.2)

Serious adverse event (SAE) to switch-overf

n (%)

14 (1.9)

16 (6.3)

118 (1.5)

201 (2.5)

Related serious adverse event

0

2 (0.8)

10 (0.1)

5 (0.1)

SAE leading to discontinuation

0

2 (0.8)

8 (0.1)

15 (0.2)

Medically-attended adverse event to switch-overf

n (%)

114 (15.2)

57 (22.5)

975 (12.1)

1178 (14.6)

Related medically-attended adverse event

5 (0.7)

4 (1.6)

91 (1.1)

63 (0.8)

Death

n (%)

0

0

5 (0.1)

16 (0.2)

  1. aIn Phase 1/2/3a 1 participant randomized to ARCT-154 who erroneously received placebo was included in the placebo group for safety analysis.
  2. bIn Phase 3b, 7 “placebo” participants did not receive placebo and were excluded from safety analysis.
  3. cEight participants (2 ARCT-154 and 6 placebo) received incorrect study product as Dose 2 and were excluded from the safety analysis post-Dose 2.
  4. dSolicited adverse events occurring within 7 days of vaccination.
  5. eAdverse events reported within 28 days of each vaccination.
  6. fSerious and medically-attended adverse events recorded from Day 1 to Day 92 (before switch-over).
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