Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

NCT ID: NCT03813940

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2021-04-01

Brief Summary

This phase I clinical study was designed to evaluate the safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Detailed Description

The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the participants would be actively monitored for adverse reactions/events for 1 month after each injection. SAE during the trial were followed up. And blood, liver and kidney function changes will be monitored before and 2 days after the first and third vaccination. Serum samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity as exploratory analysis.

Conditions

Condylomata Acuminata; Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HPV Vaccine,135μg/0.5ml

Participants in this arm would receive 135μg/0.5ml HPV vaccines

Group Type: EXPERIMENTAL

HPV Vaccine,135μg/0.5ml

Intervention Type: BIOLOGICAL

HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule

HPV Vaccine,270μg/1.0ml

Participants in this arm would receive 270μg/1.0ml HPV vaccines.

Group Type: EXPERIMENTAL

HPV Vaccine,270μg/1.0ml

Intervention Type: BIOLOGICAL

HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule

Interventions

HPV Vaccine,135μg/0.5ml

HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule

Intervention Type: BIOLOGICAL

HPV Vaccine,270μg/1.0ml

HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Health people aged between 18 and 45 years.

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

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

4. Written informed consent obtained from the participants.

5. Axillary temperature not higher than 37.0°C

6. Men, or non-pregnant women 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 or plan to use within 7 months.

5. Administration of any attenuated live vaccines within 21 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 , 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. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.

12. Having serious disease of internal medicine, such as hypertension(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al.

13. Diagnosed coagulant function abnormality or blood coagulation disorder. 14) The results of blood routine test and blood biochemical test were abnormal. The grade was 2 or above.

15) 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.

16) Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or hve a tendency to commit suicide in the past 5 years.

17) 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: 45 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

Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang, Master

Role: STUDY_CHAIR

Xiamen University

Yue-Mei Hu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Centre for Disease Control and Prevention

Locations

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Countries

China

References

Chu K, Bi ZF, Huang WJ, Li YF, Zhang L, Yang CL, Jiang HM, Zang X, Chen Q, Liu DL, Pan HX, Huang Y, Zheng FZ, Zhang QF, Sun G, Su YY, Huang SJ, Pan HR, Wu T, Hu YM, Zhang J, Zhu FC, Xia NS. Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial. Lancet Reg Health West Pac. 2023 Mar 13;34:100731. doi: 10.1016/j.lanwpc.2023.100731. eCollection 2023 May.

Reference Type: DERIVED

PMID: 37283969 (View on PubMed)

Other Identifiers

HPV-PRO-007

Identifier Type: -

Identifier Source: org_study_id