drugset / Trial / NCT02405520
Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
Phase 1
Completed
145 enrolled
Jun Zhang
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. · collabXiamen Innovax Biotech Co., Ltd · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This phase I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.
Timeline
- Start
- 2015-03-26
- Primary completion
- 2019-06-05
- Completion
- 2022-05-20
Publications
- Calvin Devadasan JD, Nithyanandhan K, Fletcher GJ, Kannangai R, Abraham P. HPV vaccines - A game changer for preventing HPV-related cancers. Indian J Med Microbiol. 2025 May-Jun;55:100847. doi: 10.1016/j.ijmmb.2025.100847. Epub 2025 Apr 10.
- Mo ZJ, Bi ZF, Sheng W, Chen Q, Huang T, Li MQ, Cui XL, Wangjiang YH, Lin BZ, Zheng FZ, Sun G, Li YF, Zheng Y, Zhuang SJ, Su YY, Pan HR, Huang SJ, Wu T, Zhang J, Xia NS. Safety and immunogenicity of an Escherichia coli-produced bivalent human papillomavirus type 6/11 vaccine: A dose-escalation, randomized, double-blind, placebo-controlled phase 1 trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2092363. doi: 10.1080/21645515.2022.2092363. Epub 2022 Jul 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HPV 6/11 bivalent vaccine | Vaccine | 30 ug | Intramuscular |
| Subject | HPV 6/11 bivalent vaccine | Vaccine | 60 ug | Intramuscular |
| Subject | HPV 6/11 bivalent vaccine | Vaccine | 90 ug | Intramuscular |