A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults

Figures & data

Figure 1. Disposition of study participants.

Table 1. Patient demographic characteristics^a

		rLP2086 vaccine group
	Control n = 12	60 µg n = 12	120 µg n = 12	200 µg n = 12	Total n = 48
Females, n (%) Males, n (%)	7 (58.3) 5 (41.7)	6 (50.0) 6 (50.0)	6 (50.0) 6 (50.0)	10 (83.3) 2 (16.7)	29 (60.4) 19 (39.6)
Race, n (%) White Black/African American	8 (66.7) 4 (33.3)	10 (83.3) 2 (16.7)	12 (100.0) 0	8 (66.7) 4 (33.3)	38 (79.2) 10 (20.8)
Ethnicity, n (%) Hispanic/Latino Non-Hispanic/Latino	7 (58.3) 5 (41.7)	7 (58.3) 5 (41.7)	9 (75.0) 3 (25.0)	8 (66.7) 4 (33.3)	31 (64.6) 17 (35.4)
Age, years Mean (SD) Median Range	27.2 (5.77) 28.5 19–36	29.3 (7.40) 28.0 19–40	31.0 (7.65) 31.5 18–40	27.8 (6.05) 27.0 20–38	28.8 (6.72) 30.0 18–40

^a Safety population, which includes all randomized subjects who received at least 1 vaccination. SD, standard deviation.

Figure 2. Immunoglobulin G (IgG) geometric mean titers (GMT) specific for LP2086 A and B subfamilies. Anti-rLP2086 IgG antibody binding to the rLP2086 subfamily A (panel A) and subfamily B (panel B) proteins after immunization at three dose levels of rLP2086 or control is shown. GMTs are plotted on a logarithmic scale and shown with 95% confidence intervals (CI). n = Number of subjects with available data.

Table 2. Local reactions reported within 7 days of each immunization by dose

Table 3. Systemic events reported within 7 days of each immunization by dose

Table 4. Subjects reporting fever within 7 days of each immunization by dose