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Table 2 Frequency of adverse events at enrolment, and months 1, 2, 6 and 7, by study arm (total visits = 600)

From: Using surrogate vaccines to assess feasibility and acceptability of future HIV vaccine trials in men: a randomised trial in inner-city Johannesburg, South Africa

Type of event Enrolment
(n = 150) n events (%)
Month 1 (pre-vaccination), 2 (post-vaccination)
(n = 141) n events (%)
Month 6 (pre- vaccination), 7 (post- vaccination)
(n = 139) n events (%)
Total
N events (%)
IV (n = 75) DV (n = 75) IV (n = 71) DV (n = 70) IV (n = 71) DV (n = 68)
   Pre Post ‘Pre’ ‘Post’ Pre Post ‘Pre’ ‘Post’
Chills 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (2.7) 3 (4.1) 2 (2.7) 1 (1.3) 1 (1.4) 1 (1.4) 10 (0.7)
Headache 0 (0.0) 2 (2.7) 1 (1.3) 3 (4.0) 3 (4.1) 0 (0.0) 3 (4.0) 0 (0.0) 0 (0.0) 1 (1.4) 13 (1.0)
Nausea 2 (2.7) 1 (1.4) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 0 (0.0) 5 (0.4)
Fatigue 0 (0.0) 0 (0.0) 1 (1.3) 1 (1.3) 1 (1.4) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 0 (0.0) 5 (0.4)
Limited ADLc 0 (0.0) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 2 (0.2)
Dizziness 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.3) 2 (2.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (0.2)
Injection site soreness 0 (0.0) 0 (0.0) 1 (1.3) 3 (4.0) 0 (0.0) 0 (0.0) 0 (0.0) 6 (8.0) 0 (0.0) 0 (0.0) 10 (0.7)
Injection site swelling 0 (0.0) 0 (0.0) 1 (1.3) 1 (1.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (0.2)
Allergic reaction 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)
Otherb 5 (6.7) 4 (5.4) 0 (0.0) 2 (2.7) 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.3) 0 (0.0) 0 (0.0) 11 (0.8)
Total 7 (9.3) 7 (9.3) 5 (7.0) 12 (16.9) 8 (11.4) 3 (4.3) 7 (9.9) 9 (12.7) 1 (1.5) 2 (2.9) 61 (10.2)a
  1. aAEs collected at total of 600 visits; Post-vaccination events in IV arm include events 30 mins or 1 month after vaccination; DV arm ‘pre’ AEs are those recorded at time of visit, and ‘post’ are AEs at visit 1 month later.bOther reported AEs include: cough, nights sweats and tonsillitis; cActivities of daily living. Fisher’s exact test done to compare groups, all P values were >0