Table 2.
Adverse reaction | PLWH group (n = 46) |
Control group (n = 38) |
P value | ||
---|---|---|---|---|---|
First dose | |||||
Total adverse reactions | 14 (30.4) | 12 (31.6) | 0.91 | ||
Systemic reactions | 5 (10.9) | 2 (5.3) | 0.35 | ||
Coughing | 1 (2.2) | 2 (5.3) | 0.45 | ||
Diarrhea | 0 | 0 | – | ||
Fatigue | 4 (8.7) | 0 | 0.06 | ||
Fever | 0 | 0 | |||
Headache | 0 | 0 | – | ||
Nausea and vomiting | 0 | 0 | – | ||
Pruritus (non-inoculated site) | 0 | 0 | – | ||
Local reactions | 14 (30.4) | 11 (28.9) | 0.88 | ||
Itching | 0 | 0 | - | ||
Pain | 11 (23.9) | 9 (23.7) | 0.98 | ||
Redness | 1 (2.2) | 1 (2.6) | 0.89 | ||
Swelling | 2 (4.3) | 1 (2.6) | 0.67 | ||
Rash | 0 | 0 | – | ||
Second dose | |||||
Total adverse reactions | 5 (10.9) | 9 (23.7) | 0.12 | ||
Systemic reactions | 1 (2.2) | 3 (7.9) | 0.22 | ||
Coughing | 0 | 2 (5.3) | 0.12 | ||
Diarrhea | 0 | 0 | – | ||
Fatigue | 1 (2.2) | 1 (2.6) | 0.89 | ||
Fever | 0 | 0 | |||
Headache | 0 | 0 | – | ||
Nausea and vomiting | 0 | 0 | – | ||
Pruritus (non-inoculated site) | 0 | 0 | – | ||
Local reactions | 4 (8.7) | 6 (13.8) | 0.32 | ||
Itching | 0 | 0 | - | ||
Pain | 4 (8.7) | 5 (13.2) | 0.51 | ||
Redness | 0 | 1 (2.6) | 0.27 | ||
Swelling | 0 | 0 | – | ||
Rash | 0 | 0 | – |
Data are shown as No. of participants with the event (%). A participant was only counted once in the specific reaction category even though a participant could have more than 1 adverse reaction. P value calculated using Chi-square test or Fisher’s exact test