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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule
HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China
Solicited local adverse reactions
Solicited local adverse reactions occurred within 7 days after each vaccination;
Time frame: 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;
Time frame: During the 7-day (Day 0-6) period following each vaccination
Unsolicited adverse events
Unsolicited adverse reactions occurred within 30 days after each vaccination;
Time frame: Within 30 days (Day 0-29) after any vaccination
Serious adverse events
Serious adverse events occurred throughout the study;
Time frame: throughout the study period, an average of 7 months
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".
Time frame: 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".
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Time frame: Before and the second day after the first and third vaccination