This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
640
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody)
Time frame: 7 months
Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)
Time frame: 7 months
Number of serious adverse events throughout the study
All the serious adverse events throughout the study would be recorded.
Time frame: 7 months
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Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.