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HPV 16/18 VLP AS04 · 10 trials · 1 indication
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Cervarix | EXPERIMENTAL | Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). |
| Placebo | PLACEBO_COMPARATOR | Subjects who received 3 doses of Placebo (at 0, 1, 6 months). |
| Aimmugen Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule. |
| HPV-16/18 Group | ACTIVE_COMPARATOR | Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA A Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA B Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA C Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA D Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA E Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| HPV-TETRA F Group | EXPERIMENTAL | Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule. |
| Name | Type | Description |
|---|---|---|
| HPV-16/18 VLP/AS04 vaccine (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| Placebo | BIOLOGICAL | Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule. |
| HPV-16/18 L1 VLP AS04 (Cervarix TM) | BIOLOGICAL | Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule. |
| HPV-16/18 L1 VLP AS04 | BIOLOGICAL | - |
| HPV-16/18 L1/AS04 | BIOLOGICAL | - |
| HPV-16/18 vaccine (Cervarix™) | BIOLOGICAL | Intramuscular injection, 3 doses |
| Aimmugen™ | BIOLOGICAL | Intramuscular injection, 3 doses |
| HPV 16/18 L1 AS04 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 1 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 2 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 3 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 4 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 5 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV-16/18/31/45 L1 AS04 Formulation 6 | BIOLOGICAL | 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6. |
| HPV 16/18 VLP AS04 | BIOLOGICAL | - |
Inclusion Criteria: * Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 15 and 25 years of age at the time of the first vaccination. * Written info...
HPV 16/18 VLP AS04 is a vaccine developed for the prevention of infections caused by human papillomavirus types 16 and 18. It is indicated for use in females to prevent HPV-related infections and associated diseases. The vaccine is designed to induce an immune response against these high-risk HPV types.
HPV 16/18 VLP AS04 is developed and manufactured by GSK plc, which trades under the ticker symbol GSK. GSK is a global pharmaceutical company that conducts research and development in vaccines and other therapeutic areas.
HPV 16/18 VLP AS04 is in Phase 3 clinical development. It has been evaluated in multiple completed Phase 3 trials, and no active trials are currently ongoing. The vaccine is investigational and has not been approved by regulatory authorities for commercial use.
HPV 16/18 VLP AS04 has been studied in 10 completed clinical trials, including NCT00485732, NCT00345878, NCT00344032, and NCT00316693. These trials enrolled a total of 6,492 participants and were conducted in countries such as South Korea, Malaysia, India, and Japan.
Yes, HPV 16/18 VLP AS04 is also known as Cervarix. Other alternative names include HPV 16/18 L1 AS04, HPV-16/18 vaccine (Cervarix), HPV-16/18 L1/AS04, and HPV-16/18 VLP/AS04 vaccine. These names refer to the same vaccine developed by GSK.