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Table 2 Serious adverse events (SAE) (phase I primary end point)

From: Intradermal injection of a Tat Oyi-based therapeutic HIV vaccine reduces of 1.5 log copies/mL the HIV RNA rebound median and no HIV DNA rebound following cART interruption in a phase I/II randomized controlled clinical trial

Volunteers

Groups (µg)

Events

Timea

Due to vaccine

No 2

11

Facial neuralgia

M11

Possible

No 24

99

Diarrhea

M3

Doubtful

No 36

99

Tuberculosis

M3

Doubtful

No 41

33

Hernia hiatus repair

M9

Not possible

No 47

33

Haemorrhoids

D-7

Not possible

  1. aTime is expressed in months (M) after the first injection or in days (D) before the first injection