Clinical trial · Interventional
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) | Biological | — | UNRESOLVED |
| Octavalent HPV with 120 mcg IMX / AAHS | Biological | — | UNRESOLVED |
| Octavalent HPV with 15 mcg IMX / AAHS | Biological | — | UNRESOLVED |
| Octavalent HPV with 30 mcg IMX / AAHS | Biological | — | UNRESOLVED |
| Octavalent HPV with 60 mcg IMX / AAHS | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- qHPV (GARDASIL™) - Phase A Control
- description
- 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.
- interventionNames
- Biological: Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
- type
- EXPERIMENTAL
- label
- Octavalent HPV with 15 mcg IMX / AAHS
- description
- 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.
- interventionNames
- Biological: Octavalent HPV with 15 mcg IMX / AAHS
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 24 Years
Show eligibility criteria text
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 has a history of recent or ongoing alcohol or drug abuse * Participant is immunocompromised or has an autoimmune condition * Participant has received immunosuppressive therapy within a year of screening * Participant has previously received an HPV vaccine * Participant is pregnant * Participant has a history of external genital/vaginal warts * Participant is currently enrolled in a clinical trial * Participant has a history of a severe allergic reaction that required medical attention
References
Publications (0)
Data not yet available