Clinical trial · Interventional
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years
- 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 is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli. The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events. The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
Conditions
Conditions (2)
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 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 30μg HPV | Biological | — | UNRESOLVED |
| 60μg HPV | Biological | — | UNRESOLVED |
| 90μg HPV | Biological | — | UNRESOLVED |
| Hepatitis B vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 30μg HPV
- description
- Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
- interventionNames
- Biological: 30μg HPV
- type
- EXPERIMENTAL
- label
- 60μg HPV
- description
- Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
- interventionNames
- Biological: 60μg HPV
- type
- EXPERIMENTAL
- label
- 90μg HPV
- description
- Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent from the subject prior to enrolment; * Female between, and including, 18 and 25 years of age at the time of enrolment; * Subjects must be free of obvious health problems; * Not pregnant and having no plan for pregnancy; Exclusion Criteria: * Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7); * Previous vaccination against HPV; * Having severe allergic history or other immunodeficiency; * Chemotherapy and other immunosuppressive agents using;
References
Publications (1)
- RESULTWu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19. PMID 26100924