Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the participants would be actively monitored for adverse reactions/events for 1 month after each injection. SAE during the trial were followed up. And blood, liver and kidney function changes will be monitored before and 2 days after the first and third vaccination. Serum samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity as exploratory analysis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Vaccine,135μg/0.5ml | Experimental | Participants in this arm would receive 135μg/0.5ml HPV vaccines |
|
| HPV Vaccine,270μg/1.0ml | Experimental | Participants in this arm would receive 270μg/1.0ml HPV vaccines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine,135μg/0.5ml | Biological | HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local adverse reactions | Solicited local adverse reactions occurred within 7 days after each vaccination; | During the 7-day (Day 0-6) period following each vaccination |
| Solicited systematic adverse reactions | Solicited systematic adverse reactions occurred within 7 days after each vaccination; | During the 7-day (Day 0-6) period following each vaccination |
| Unsolicited adverse events | Unsolicited adverse reactions occurred within 30 days after each vaccination; | Within 30 days (Day 0-29) after any vaccination |
| Serious adverse events | Serious adverse events occurred throughout the study; | throughout the study period, an average of 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Relevant Abnormalities in Blood Biochemistry | Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase basophils, total bilirubin, direct bilirubin, indirect bilirubin, creatinine, urea nitrogen. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below". |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) | To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3 | month 7 |
Inclusion Criteria:
Exclusion criteria:
15) Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.
16) Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.
17) Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, Master | Xiamen University | Study Chair |
| Yue-Mei Hu, Bachelor | Jiangsu Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Centre for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37283969 | Derived | Chu K, Bi ZF, Huang WJ, Li YF, Zhang L, Yang CL, Jiang HM, Zang X, Chen Q, Liu DL, Pan HX, Huang Y, Zheng FZ, Zhang QF, Sun G, Su YY, Huang SJ, Pan HR, Wu T, Hu YM, Zhang J, Zhu FC, Xia NS. Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial. Lancet Reg Health West Pac. 2023 Mar 13;34:100731. doi: 10.1016/j.lanwpc.2023.100731. eCollection 2023 May. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HPV Vaccine,270μg/1.0ml | Biological | HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule |
|
| Before and the second day after the first and third vaccination |
| Clinically Relevant Abnormalities in Hematological Parameters | Hematological Parameters assessed in blood samples include platelets, red blood cell, hemoglobin and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below". | Before and the second day after the first and third vaccination |
| Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) |
To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3 |
| month 7 |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |