TABLE 1.
Viral load and gB genotypes detected in clinical samples from placebo recipients and gB/MF59 vaccinees using different sequencing methodologies
| No. | Virus genotype |
Antibody titer |
Viral load by anatomic compartment (log10 range [n])a |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Sanger seq gB (subtype) | NGS full gB ORF | SNAPP gB | Endpoint gB (log10) | Neutralizing (log2) | Blood | Urine | Saliva | Vaginal fluid | |
| Placebo | |||||||||
| 1 | 4 (D2) | 4, 5 | 1, 4, 5 | 3.99 | 6 | —b | <2 (2) | — | 2.91–3.25 (2) |
| 2 | 3 (C1) | 3 | 1, 3 | 4.15 | 8 | — | 2.48 (1) | — | 4.50 (1) |
| 3 | 3 (C1) | 3 | 1, 3 | 4.27 | 8 | — | — | 3.05 (1) | |
| 4 | 1 (B2gaa) | 1 | 1, 5 | 4.40 | 8 | <2 (1) | <2–2.13 (2) | <2 (2) | <23.66 (2) |
| 5 | 2 (A1) | 2 | 1, 2, 5 | 3.24 | 3 | <2 (1) | <2 (1) | <2 (1) | 3.74 (1) |
| 6 | 3 (C1) | — | 1c | 4.06 | 7 | — | <2 (1) | — | — |
| 7 | 2 (A1) | — | 2 | 4.27 | 7 | — | 3.02 (1) | 2.25 (1) | — |
| 8 | 1 (B2gga) | 1 | 1 | 4.53 | 8 | <2 (3) | <2 (2) | <2–2.13 (2) | <2 (2) |
| 9 | 1 (B2gaa) | 1 | — | 3.68 | 6 | <2 (2) | <2 (2) | <2 (2) | <2–2.49 (2) |
| 10 | 1 (B2gaa) | 1 | — | 3.94 | 7 | <2 (2) | <2–2.63 (2) | <2–2.09 (2) | <2–3.87 (2) |
| 11 | 4, 1 (D2, B2gaa) | 4,1 | 4,1 | 4.29 | 4 | <2 (3) | <2 (2) | <2 (2) | <2 (2) |
| 12 | 1 (B2gga) | 1 | 1 | 4.56 | 7 | <2–2.78 (3) | 2.93–4.93 (4) | 3.15–4.07 (3) | 3.23–3.61 (2) |
| 13 | 1 (B1gga) | — | — | 3.00 | 1 | <2 (3) | <2 (2) | ||
| 14 | 1 (B2gaa) | 1 | 1 | 4.51 | 8 | <2 (2) | <2 (2) | <2 (2) | <2 (2) |
| 15 | 5 (E) | 5 | 1, 5 | 4.27 | 7 | — | <2 (3) | <2–4.23 (6) | <2 (1) |
| 16 | 5 (E) | — | — | 3.77 | 6 | — | <2 (1) | <2–3.83 (2) | 3.74–3.85 (2) |
| 17 | 5 (E) | 5 | 5 | 3.80 | 5 | <2 (2) | <2 (1) | 2.66 (1) | 4.69 (1) |
| 18 | 5 (E) | — | — | 2.30–3.22 (2) | 2.89 (1) | — | 3.15 (1) | ||
| 19 | 5 (E) | — | — | 3.87 | 3 | <2–2.47 (4) | 2.70–2.97 (2) | — | <2–4.27 (2) |
| 20 | 5 (E) | — | — | 4.21 | 8 | <2 (2) | 2.24 (1) | <2 (1) | 3.03 (1) |
| 21 | 5 (E) | — | — | 4.46 | 8 | <2 (1) | <2 (2) | <2–3.02 (2) | <2–3.22 (2) |
| gB/MF59 vaccinee | |||||||||
| 22 | 3 (C1) | 3 | 1, 3, 5 | 4.97 | 7 | — | 3.02 (1) | <2 (1) | 3.31 (1) |
| 23 | 5, 1 (E, B2gaa) | — | — | 4.99 | 6 | — | <2 (4) | <2 (5) | <2 (2) |
| 24 | 1 (B1gga) | — | — | 5.81 | 9 | <2 (1) | <2–2.47 (2) | <2 (2) | <2–2.90 (2) |
| 25 | 1 (B2gga) | 5c | 1 | 5.27 | 9 | <2 (2) | <2 (2) | <2–2.74 (2) | <2 (2) |
| 26 | 1 (B2gga) | — | — | 5.07 | 7 | <2 (2) | <2 (2) | <2–2.31 (2) | <2 (2) |
| 27 | 3 (C2) | 3 | 1, 3 | 5.59 | 10 | — | <2–2.16 (3) | <2–2.54 (2) | 2.52 (1) |
| 28 | 5 (E) | — | — | 5.15 | 8 | <2 (3) | 2.16–3.32 (2) | <2 (1) | <2–4.02 (2) |
| 29 | 5 (E) | — | — | 5.43 | 7 | — | 2.18–2.31 (2) | <2 (1) | — |
| 30 | 5 (E) | 5 | 1, 5 | 5.76 | 10 | <2–2.35 (2) | — | <2 (1) | — |
| 31 | 5 (E) | — | — | 4.75 | 8 | <2–2.71 (4) | <2 (2) | <2 (1) | <2–3.53 (2) |
| 32 | 5 (E) | 5 | 1, 5 | 6.52 | 10 | <2–2.34 (3) | <2–3.04 (2) | <2 (1) | <2–2.94 (3) |
a
Quantitative PCR limit of detection is 2 log10 copies/ml.
b
—, data omitted due to lack of available sample for given subject/anatomic compartment.
c
Sequence discrepant with Sanger sequencing. Result could not be confirmed due to sample limitation.