NCT02405520

Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine

A Phase I Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Jun Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Condylomata Acuminata

Interventions

Type	Name	Description
BIOLOGICAL	low dosage HPV Vaccine	Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
BIOLOGICAL	medium dosage HPV Vaccine	Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
BIOLOGICAL	high dosage HPV Vaccine	Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
BIOLOGICAL	Aluminium Adjuvant	Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.

Timeline

• Start date: 2015-03-26
• Primary completion: 2019-06-05
• Completion: 2022-05-20
• First posted: 2015-04-01
• Last updated: 2022-05-24