Exploratory clinical studies of a synthetic HIV-1 Tat epitope vaccine in asymptomatic treatment-naïve and antiretroviral-controlled HIV-1 infected subjects plus healthy uninfected subjects

Figures & data

Figure 1. CONSORT subject disposition chart.

Table 1. Baseline demographics and injection related adverse reactions

	Treatment Groups (dose TUTI-16)
	Placebo	30 μg	100 μg	600 μg
Age (years)
Mean (SD)	51 (5)	44 (10)	48 (9)	41 (8)
Range	47–60	29–56	38–61	31–54
Gender
Male	5	6	7*	5*
Female	0	0	0	1
Race
Caucasian	4	5	4	5
Latino/Hispanic	0	1	1	1
Black	0	0	2	0
Asian	1	0	0	0
Injection Related Reactions
Local**	1	1	1	4
Systemic***	0	2	0	1

* One subject in each group was discontinued early for failed entry criterion and non-compliance (went to Australia), respectively; ** Redness, tenderness, pain, or induration, all mild; ***Fatigue, weakness, one mild one moderate, plus one subject with mild nausea.

Figure 2. Mean changes from baseline of anti-Tat antibody concentrations following TUTI-16 immunization. Treatment naïve HIV subjects (solid lines): placebo red circle, 30 μg TUTI-16 blue circle, 100 μg TUTI-16 brown square, 600 μg TUTI-16 plum diamond. Healthy HIV seronegative subjects (dashed lines): 200 μg TUTI-16 orange hexagonal, 1.0 mg TUTI-16 orange square; ART controlled HIV subjects: 200 μg TUTI-16 magenta diamond. Treatment naïve HIV randomized study immunizations at 0, 4 and 12 weeks; open label immunizations at 0 and 3 weeks.

Figure 3. Baseline log HIV viral counts (mean ± SEM).

Figure 4. Mean changes from baseline of log viral count during the 5 mo following the initial immunization. Each point represents the mean of 6 determinations from a single subject. ⁺⁺pc0.01

Figure 5. Baseline CD4 T cell counts (mean ± SEM).

Figure 6. Mean change from baseline of CD4 T cell counts in each treatment group during the 5 mo following the first immunization.