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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dosage HPV Vaccine | Experimental | Participants in this arm would receive low dosage of HPV vaccines. |
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| medium dosage HPV Vaccine | Experimental | Participants in this arm would receive medium dosage of HPV vaccines. |
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| high dosage HPV Vaccine | Experimental | Participants in this arm would receive high dosage of HPV vaccines. |
|
| Placebo | Placebo Comparator | Participants in this arm would receive placebo (Aluminium Adjuvant). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dosage HPV Vaccine | Biological | Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure adverse reactions/events throughout the study | With composite measure: Measure solicited local/systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure blood, liver and kidney function changes pre- and 2 days post vaccination; Measure serious adverse events occurred throughout the study | 10 month |
| Measure | Description | Time Frame |
|---|---|---|
| Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations. | 7 month |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, Master | Xiamen University | Study Chair |
| Zhao-Jun Mo, Master | Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control | Principal Investigator |
| Ting Wu, Ph. D | Xiamen University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40221095 | Derived | 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. | |
| 35834812 | Derived | 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. |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| medium dosage HPV Vaccine | Biological | Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. |
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| high dosage HPV Vaccine | Biological | Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. |
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| Aluminium Adjuvant | Biological | Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses. |
|
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |