Table 3.
Reduction of HBV and HCV by the manufacturing process of Haemate P/Humate‐P [76].
| HBV | HCV* | ||
|---|---|---|---|
| Study 1 | Study 2 | ||
| Spiked starting material | |||
| Theoretical infectivity in starting material – assuming no virus reduction (CID50) | 5.6 log10 | 5.6 log10 | 5.5 log10 |
| Number of chimpanzees | 2 | 2 | 2 |
| Volume of inoculum (mL) | 1 | 1 | 1 |
| Seropositive chimpanzees following infection [HBsAg, α‐HBs or α‐HBc] | 2 | 2 | nd |
| First signs of infection (weeks) | 19, 26 | 24, 27 | 10, 15 |
| Intermediate before pasteurization | |||
| Number of chimpanzees | 4 | nd | nd |
| Volume of inoculum (mL) | 1 | nd | nd |
| Seropositive chimpanzees following infection [HBsAg, α‐HBs or α‐HBc] | 4 | nd | nd |
| First signs of infection (weeks) | 9, 12, 13, 25 | nd | nd |
| Final product | |||
| Number of chimpanzees | 4 | 3 | 4 |
| Volume of inoculum (mL) | 1 | 1 | 1 or 24 (2 chimpanzees each) |
| Seropositive chimpanzees following infection [HBsAg, α‐HBs or α‐HBc] | 0 | 0 | nd |
| Signs of infection at close of study (weeks) | None (28–41) | None (38) | None (22) |
| Overall virus reduction factor (CID50) | >5.6 log10 | >5.6 log10 | >5.5 log10 |
HBV, hepatitis B virus; HCV, hepatitis C virus; nd, not determined.
*HCV: at the time of experiments, this virus was known as non‐A, non‐B hepatitis virus.
CID50 is defined as the dose that is necessary to initiate infection in 50% of chimpanzees.
α‐HBs are antibodies directed against the hepatitis B virus surface antigen.
α‐HBc is an antibody directed against the hepatitis B virus core antigen.