Summary of clinical safety.

Statistical significance was set at p<0.05.
*Moderate local reactions occurred in 3 TC vaccinated healthy individuals and included erythema at D1 in one volunteer and erythema at D3 in another one. The third volunteer experienced erythema and swelling at D1 and erythema at D3. No local reactions occurred in IM vaccinated subjects.
**Three moderate systemic reactions were recorded for cohort I subjects. The subject receiving IM vaccination experienced pain while breathing after sport accident on D7 and D14. Only volunteer experienced vomiting at D28 after TC vaccination. Axillary adenopathy occurred in one TC vaccinated subject at D7 and D14 and was the only systemic event, which was considered as related to the mode of administration by the investigator.
#Moderate local reactions occurred in 6 TC vaccinated HIV-infected individuals and included erythema at D3 in one volunteer, erythema at D14 in another volunteer as well as itching at D1 and D3 in two subjects. One volunteer experienced Itching at D1 followed by erythema at D3, D7, D14 and D21. One erythema and desquamation in D14, D21 and D28. No local reactions occurred in IM vaccinated subjects.
##Two moderate systemic reactions were recorded for cohort II subjects. Only volunteer reported an upper respiratory tract infection at D28 after IM vaccination. One TC vaccinated individual experienced malaise and myalgia at D1 after vaccination.