This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
Gent University & Hospital, Center for Vaccinology
Ghent, Belgium
Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever
Time frame: 14-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of fever
Time frame: 21-day follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)
Time frame: 42-day follow-up after each vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)
Time frame: During the study period (Month 0-11)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4)
Time frame: During the study period (Month 0-11)
Occurrence of shedding of recombinant virus
Time frame: During the study period (Month 0-11)
Recombinant virus infectivity
Time frame: During the study period (Month 0-11)
Cell-mediated immune response (CMI)
Time frame: At day 0, 7, 14, 28, 91, 98, 112, 266
Humoral immune response to HIV antigens
Time frame: At day 14, 28, 84, 98, 112, 266.
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