Table 1.
Study timepoints for vaccination schedule and immunogenicity assessments.
| D 0 | W 6 | W 10 | M 6 | M 7 | M 12 | M 18 | M 24 | |
|---|---|---|---|---|---|---|---|---|
| Vaccination (AS04-HPV-16/18 or 4vHPV) | Dose 1 | Dose 2 | – | Dose 3 | – | – | – | – |
| HPV-16/18 humoral response | PBNA | – | – | – | PBNA | – | – | – |
| ELISA | ELISA | ELISA | – | ELISA | ELISA | ELISA | ELISA | |
| HPV-16/18 cell-mediated immunity* | ELISPOT | ELISPOT | ELISPOT | – | ELISPOT | ELISPOT | – | – |
| ICS | ICS | ICS | – | ICS | ICS | – | – | |
| cervico-vaginal secretions⁎⁎ | ELISA | ELISA | ELISA | – | ELISA | ELISA | – | ELISA |
D: day; ELISA: Enzyme-linked Immunosorbent Assay; ELISPOT: Enzyme-linked Immunospot; HPV: human papillomavirus; ICS: Intracellular Cytokine Staining; M: month; PBNA: Pseudovirion-Based Neutralization Assay; W: week.
⁎
Memory B-cells by ELISPOT and CD4/CD8 T cells by ICS.
⁎⁎
Immunoglobulin G and anti-HPV16/18 by ELISA in cervico-vaginal secretion samples.