Table 2 Adverse events

From: Immunogenicity phase II study evaluating booster capacity of nonadjuvanted AKS-452 SARS-Cov-2 RBD Fc vaccine

Symptomsa

Number of Eventsb

Local (related to AKS-452 dose)

 Injection site pain

1

2%

 Injection site reaction (both redness and swelling)

30 + 2*

68%

 Injection site swelling

3

6%

 Injection site redness

6 + 1*

15%

 Painful arm

3 + 1*

9%

 TOTAL

47

 

General (related to AKS-452 dose)

 Fatigue

1 + 1* + 1c

38%

 Muscle ache

1

13%

 General malaise

1

13%

 Common cold

1

13%

 Headache

1

13%

 Papular rash

1c*

13%

 TOTAL

8

 
  1. aAll AEs were collected in a solicited manner during days 0 to 273 after receiving the AKS-452 dose. All AEs were deemed “mild” and all were “Possibly, Probably, or Definitely” Related to Vaccination with AKS-452 except the occurrence of COVID-19. Note that 50 of the 71 total subjects showed AEs related to AKS-452 dosing. There were no Serious Adverse Events (SAE’s) reported in the study.
  2. bAEs appeared within 7 days of AKS-452 dose and resolved within 7 days of appearance unless designated with “*“ in which case the AE resolved >11 and < 52 days.
  3. cAEs appeared between 12 and 15 days of AKS-452 dose.