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

NCT ID: NCT02710851

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-24
• Study Completion Date: 2023-12-30

Brief Summary

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.

Conditions

Condylomata Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

low dosage HPV Vaccine(1:1)

Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio.

Group Type: EXPERIMENTAL

low dosage HPV Vaccine(1:1)

Intervention Type: BIOLOGICAL

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.

low dosage HPV Vaccine(1:2)

Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:2 ratio.

Group Type: EXPERIMENTAL

low dosage HPV Vaccine(1:2)

Intervention Type: BIOLOGICAL

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.

high dosage HPV Vaccine(1:1)

Participants in this arm would receive high dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio.

Group Type: EXPERIMENTAL

high dosage HPV Vaccine(1:1)

Intervention Type: BIOLOGICAL

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.

Hepatitis E vaccine,Hecolin®

Participants in this arm would receive Hepatitis E vaccine,Hecolin®

Group Type: PLACEBO_COMPARATOR

Hepatitis E vaccine,Hecolin®

Intervention Type: BIOLOGICAL

Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.

Interventions

low dosage HPV Vaccine(1:1)

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.

Intervention Type: BIOLOGICAL

low dosage HPV Vaccine(1:2)

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.

Intervention Type: BIOLOGICAL

high dosage HPV Vaccine(1:1)

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.

Intervention Type: BIOLOGICAL

Hepatitis E vaccine,Hecolin®

Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Participants aged between 18 and 55 years.

2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.

3. Written informed consent obtained from the participants.

4. Able to comply with the requests of the study.

5. Axillary temperature not higher than 37.0°C

6. Non-pregnancy verified by a urine pregnancy test.

Exclusion Criteria

1. Pregnant or breastfeeding or plan to be pregnant within 7 months.

2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.

3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.

4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine.

5. Administration of any attenuated live vaccines within 30 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.

6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.

7. Having the plan to participate another clinical trial during the study period.

8. Received another HPV vaccine.

9. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).

10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.

11. Having serious disease of internal medicine, such as hypertension, cardiac disease, diabetes, hyperthyroidism et al.

12. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.

13. Diagnosed coagulant function abnormality (i.e., clotting factors absent, clotting hemorrhagic disease, abnormal platelet function) or blood coagulation disorder.

14. Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years.

15. Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or h a tendency to commit suicide.

16. Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jun Zhang

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jun Zhang, Master

Role: STUDY_CHAIR

Xiamen University

Yuemei Hu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu center for Disease Prevention and Control

Other Identifiers

HPV-PRO-005

Identifier Type: -

Identifier Source: org_study_id