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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.