Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial

Figures & data

Figure 1. Trial flow diagram.

Table 1. Baseline characteristics of the participants classified by age.

	Younger adults (18–59)				Elder adults (≥60)
	10 μg (n = 24)	25 μg (n = 24)	50 μg (n = 24)	Placebo (n = 18)	10 μg (n =24)	25 μg (n = 24)	50 μg (n = 24)	Placebo (n = 18)
Age (y)
Mean (SD)	40.0 (9.2)	41.6 (12.1)	44.5 (10.6)	40.7 (11.3)	65.8 (4.4)	65.0 (2.9)	65.9 (4.0)	64.8 (4.4)
Ethnicity (%)
Han Chinese	24 (100)	24 (100)	24 (100)	18 (100)	24 (100)	24 (100)	24 (100)	18 (100)
Sex (%)
Male	6 (25.00)	11 (45.83)	14 (58.33)	10 (55.56)	16 (66.67)	20 (83.33)	19 (79.17)	18 (100.00)
Female	18 (75.00)	13 (54.17)	10 (41.67)	8 (44.44)	8 (33.33)	4 (16.67)	5 (20.83)	0 (0.00)
BMI (kg/m^2)
Mean (SD)	23.2 (3.0)	22.9 (2.6)	24.5 (2.1)	23.1 (2.5)	22.9 (2.4)	22.6 (3.1)	23.1 (2.3)	23.2 (2.7)

Note: Data are presented as mean (SD) or n (%). BMI = body-mass index.

Table 2. AEs in Phase 1 trial.

	Younger adults (18–59)					Elder adults (≥60)
AEs	10 μg (n = 24)	25 μg (n = 24)	50 μg (n = 24)	Placebo (n = 18)	P value	10 μg (n = 24)	25 μg (n =24)	50 μg (n = 24)	Placebo (n = 18)	P value
Overall AEs within 30 d
Any^a	16 (66.67)	17 (70.83)	19 (79.17)	13 (72.22)	0.8153	13 (54.17)	13 (54.17)	15 (62.50)	7 (38.89)	0.5328
Vaccination-related^b	7 (29.17)	9 (37.5)	10 (41.67)	5 (27.78)	0.7787	2 (8.33)	4 (16.67)	7 (29.17)	2 (11.11)	0.2760
Grade ≥3	0	0	0	0	1.0000	0	0	0	0	1.0000
Solicited local adverse reactions
Pain	2 (8.33)	2 (8.33)	4 (16.67)	4 (22.22)	0.5182	0	0	1 (4.17)	0	1.0000
Induration	0	0	0	0	1.0000	0	0	0	0	1.0000
Swelling	0	0	0	0	1.0000	0	0	0	0	1.0000
Rash	0	0	0	0	1.0000	0	0	0	0	1.0000
Redness	0	0	0	0	1.0000	0	0	0	0	1.0000
Pruritus	1 (4.17)	0	0	0	1.0000	0	0	0	0	1.0000
Solicited systemic adverse reactions
Fever	2 (8.33)	1 (4.17)	1 (4.17)	0	0.9026	0	0	0	0	1.0000
Diarrhoea	0	0	0	0	1.0000	0	0	0	0	1.0000
Constipation	0	0	0	0	1.0000	0	0	0	0	1.0000
Dysphagia	0	0	0	0	1.0000	0	0	0	0	1.0000
Anorexia	2 (8.33)	1 (4.17)	1 (4.17)	0	0.9026	0	0	0	0	1.0000
Vomiting	1 (4.17)	0	0	0	1.0000	0	0	0	0	1.0000
Nausea	2 (8.33)	0	0	1 (5.56)	0.2449	0	0	0	0	1.0000
Muscle pain	0	0	2 (8.33)	1 (5.56)	0.2793	0	0	0	0	1.0000
Arthralgia	0	0	0	1 (5.56)	0.2000	0	0	0	0	1.0000
Headache	1 (4.17)	0	0	1 (5.56)	0.5685	0	0	2 (8.33)	0	0.2449
Cough	0	0	1 (4.17)	1 (5.56)	0.5685	0	1 (4.17)	0	0	1.0000
Dyspnoea	0	0	0	0	1.0000	0	0	0	0	1.0000
Pruritus	0	0	0	1 (5.56)	0.2000	0	0	0	0	1.0000
Abnormal skin or mucosa	0	0	0	0	1.0000	0	0	0	0	1.0000
Acute allergic reaction	0	0	0	0	1.0000	0	0	0	0	1.0000
Fatigue	2 (8.33)	2 (8.33)	3 (12.50)	3 (16.67)	0.8832	0	1 (4.17)	3 (12.50)	0	0.2431
Unsolicited adverse reactions
Any	15 (62.50)	15 (62.50)	147 (70.83)	11 (61.11)	0.9102	12 (50.00)	12 (50.00)	15 (62.50)	7 (38.89)	0.5165
Vaccination-related	5 (20.83)	5 (20.83)	4 (16.67)	1 (5.56)	0.5269	2 (8.33)	3 (12.50)	6 (25.00)	2 (11.11)	0.4809

Notes: Data are presented as n (%). P values are calculated with Fisher’s exact test.

^a Any means the total number of AEs within 30days regardless of the causal relationship between the adverse events and vaccination.

^b Vaccination-related means adverse events within 30days was correlated with vaccination judged by the investigators.

Figure 2. Humoral immune responses in phase I trials. GMTs (A) and seroconversion rates (B) of neutralizing antibodies at different timepoints after first vaccination in phase 1. GMTs (C) and seroconversion rates (D) of RBD-binding antibodies at different timepoints after first vaccination in phase 1. Error bars represent 95% CIs of geomeans. The horizontal dashed lines in panels A and C indicate the limit of detection. RBD: receptor-binding domain.

Figure 3. Correlation of live virus neutralizing antibodies and anti-RBD IgG binding antibody response. Scatter plots of log₁₀ transformed live SARS-COV-2 neutralizing antibody responses and anti-RBD IgG binding antibody responses at day 21 (immediately before the second dose), day 28 (1 week after the second vaccination), day 35 and day 49 in the 10 (A), 25 (B), and 50 μg (C) V-01 group.