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. 2019 Oct 9;12:3169–3188. doi: 10.2147/IDR.S159952

Table 4.

Key Clinical Trials On rLP2086 Vaccine

Richmond 201272
(Australia, Poland And Spain)		 Nissen 201331 (Australia) Marshall 201332 (Australia) Vesikari 201633 (Czech Republic, Denmark, Finland, Germany, Poland, Spain, Sweden)

  1. Study characteristics

Study Design Phase II Phase II Phase II Phase III
Study subjects and age Adolescents
11–18 years		 Children
8–14 years		 Adults
18–40 years		 Adolescents
11–19 years
Dosing schedule 0, 2, and 6 months 0, 1, and 6 months 0, 1, and 6 months 0, 1, and 6 months 0, 2, and 6 months
Sample size (total) 538 127 55 426 414
(II) Immunogenicity endpoints based on strain (variant of fHBP)

  1. Proportion of patients with hSBA titers 1:16

  1. PMB2001 (A56)

  2. PMB80 (A22)

  3. PMB2707 (B44)

  4. PMB2948 (B24)

 95% (20/21)
–
76% (16/21)
–		 ** ** 88% (289/329)
62% (207/332)
30% (101/333)
45% (148/328)		 98% (332/339)
88% (303/344)
59% (194/331)
64% (214/337)
(E) Geometric mean titers

  1. PMB2001 (A56)

  2. PMB80 (A22)

  3. PMB2707 (B44)

  4. PMB2948 (B24)

 ** ** ** 152.9
55.1
40.3
29.1		 159.6
56.3
35.0
25.6
(III) Safety endpoints
Serious AE 5% (1/22) 7% (3/45) ** 3% (12/426) 3% (14/414)
AEs 8% (18/22) 9% (42/45) – 27% (113/426) 28% (115/414)

  1. Pyrexia

  2. Tenderness

 –
–		 7% (3/45)
–		 –
–		 1% (7/426)
1% (6/426)		 <1% (3/414)
<1% (4/414)

Notes: *Dosage at 60 ug per antigen, immunogenicity taken at 1 month after 3rd dose, adverse events until 30 days from 3rd dose; **No disaggregated data available.