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Table 1 In vitro infectivity to a hepatocyte line (HC-04) (potency) and sporozoite membrane integrity (viability) of the two lots of PfSPZ Challenge

From: Direct venous inoculation of Plasmodium falciparum sporozoites for controlled human malaria infection: a dose-finding trial in two centres

A) Tübingen

Release date

Potency ± standard deviation (No. of parasites expressing PfMSP-1/well)

Viability ± standard deviation

Fresh*

32.7 ± 1.5 parasites

98.2%

Release**

29.3 ± 3.1 parasites

87.4% ± 5.9%

3 months

27.3 ± 0.6 parasites

84.6% ± 1.9%

6 months

26.7 ± 1.5 parasites

83.6% ± 5.5%

9 months

26.3 ± 2.5 parasites

86.3% ± 6.5%

12 months

27.3 ± 0.6 parasites

86.2% ± 1.3%

Post last clinical dose Tübingen

24.0 ± 1.7 parasites

81.7% ± 2.6%

B) Barcelona

Release date

Potency ± standard deviation (No. of parasites expressing PfMSP-1/well)

Viability ± standard deviation

Fresh*

28.3 ± 1.5 parasites

95.5%

Release**

25.3 ± 1.5 parasites

89% ± 2.2%

3 months

21.7 ± 1.5 parasites

85% ± 3.3%

6 months

25.0 ± 5.3 parasites

86% ± 4.8%

Post last clinical dose Barcelona

19.0 ± 1.0 parasites

85% ± 4.4%

  1. *Fresh refers to the aseptic, purified PfSPZ of this lot before they were cryopreserved. Data from all other time points were generated on thawed PfSPZ Challenge.
  2. **Release refers to the data generated within a few weeks of manufacture that were used to demonstrate that PfSPZ Challenge met quality control “release” specifications. All other data are from the formal stability programme.