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Octavalent HPV with IMX/ AAHS · 1 trial · 5 indications
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
| Arm | Type | Description |
|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | ACTIVE_COMPARATOR | Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A. |
| Octavalent HPV with 15 mcg IMX / AAHS | EXPERIMENTAL | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX. |
| Octavalent HPV with 30 mcg IMX / AAHS | EXPERIMENTAL | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. |
| qHPV (GARDASIL™) - Phase B Control | ACTIVE_COMPARATOR | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B. |
| Octavalent HPV with 60 mcg IMX / AAHS | EXPERIMENTAL | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. |
| Octavalent HPV with 120 mcg IMX / AAHS | EXPERIMENTAL | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. |
| Name | Type | Description |
|---|---|---|
| Octavalent HPV with 15 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 30 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 60 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Octavalent HPV with 120 mcg IMX / AAHS | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
| Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) | BIOLOGICAL | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
Inclusion Criteria: * Participant is in good physical health * Participant has had a lifetime history of 0 to 4 sexual partners * Females between 18-to-24 years Exclusion Criteria: * Participant has a history of abnormal Pap test * Participant has a history of positive test for HPV * Participant ...
Octavalent HPV with IMX/ AAHS is an investigational vaccine being developed by Merck & Company, Inc. for the prevention of Human Papilloma Virus (HPV) infections. It is designed to target multiple HPV types and is currently in Phase 1 clinical development. The vaccine is being studied in healthy female volunteers aged 18 years and older.
Octavalent HPV with IMX/ AAHS is being developed for the prevention of Human Papilloma Virus (HPV) infections, which can lead to cervical cancer, vulvar cancer, vaginal cancer, and genital warts. The vaccine is intended to provide broad protection against multiple HPV types and is currently in Phase 1 clinical trials.
Octavalent HPV with IMX/ AAHS is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in Phase 1 clinical development for the prevention of Human Papilloma Virus infections.
Octavalent HPV with IMX/ AAHS is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is being studied for safety and immunogenicity in healthy female volunteers.
Octavalent HPV with IMX/ AAHS has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT00851643. The trial, titled 'Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)', enrolled 158 healthy female participants aged 18 years and older and was designed to evaluate the vaccine's safety and immune response.
Octavalent HPV with IMX/ AAHS is a distinct investigational vaccine developed by Merck & Company, Inc. It is designed to target eight HPV types, which is broader than some existing HPV vaccines. However, it is not yet approved and is still in clinical development, so it is not the same as currently marketed HPV vaccines.