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

Phase 1

Completed

• Conditions: Condylomata Acuminata
• Interventions: Biological: Aluminium Adjuvant; Biological: high dosage HPV Vaccine; Biological: low dosage HPV Vaccine; Biological: medium dosage HPV Vaccine

• Registration Number: NCT02405520
• Lead Sponsor: Jun Zhang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study Start: 2015-03-26
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-01
• Primary Completion: 2019-06-05
• Status Verified: 2022-05
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Aluminium Adjuvant	Participants in this arm would receive placebo (Aluminium Adjuvant).
high dosage HPV Vaccine	high dosage HPV Vaccine	Participants in this arm would receive high dosage of HPV vaccines.
low dosage HPV Vaccine	low dosage HPV Vaccine	Participants in this arm would receive low dosage of HPV vaccines.
medium dosage HPV Vaccine	medium dosage HPV Vaccine	Participants in this arm would receive medium dosage of HPV vaccines.

Primary Outcome Measures

Name	Time	Method
Measure adverse reactions/events throughout the study	10 month	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

Secondary Outcome Measures

Name	Time	Method
Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations.	7 month