This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
4mg/dose, three doses at week 0,4,8
4mg/dose, three doses at week 0,4,8
at week 16
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Occurrence, intensity and relationship to vaccination of local and general adverse events
Time frame: 14-day follow-up after DNA vaccine vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)
Time frame: During the study period (Month 0-20)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)
Time frame: During the study period (Month 0-20)
test HIV specific T cell response by ELISPOT
Time frame: 2wk, 4wk, 14wk, 24wk after rTV vaccination
test HIV specific antibody by ELISA
Time frame: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
Occurrence, intensity and relationship to vaccination of local and general adverse events
Time frame: 28-day follow-up after rTV vaccination
test HIV specific T cell response by ICS
Time frame: 4wk, 8wk, 14wk, 48wk after rTV vaccination
HIV neutralizing antibody test
Time frame: 4wk, 14wk, 48wk after rTV vaccination
vaccinia virus antibody test
Time frame: 2wk, 4wk, 24wk after rTV vaccination
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at week 24
at week 32