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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
145
Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
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
Time frame: 10 month
Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations.
Time frame: 7 month
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Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.