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

Primary Purpose

Condylomata Acuminata, Cervical Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HPV Vaccine,135μg/0.5ml

HPV Vaccine,270μg/1.0ml

About this trial

This is an interventional prevention trial for Condylomata Acuminata focused on measuring human papillomavirus vaccine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Health people aged between 18 and 45 years.
Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
Able to comply with the requests of the study.
Written informed consent obtained from the participants.
Axillary temperature not higher than 37.0°C
Men, or non-pregnant women verified by a urine pregnancy test.

Exclusion criteria:

Pregnant or breastfeeding or plan to be pregnant within 7 months.
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.
Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
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.
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.
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.
Having the plan to participate another clinical trial during the study period.
Received another HPV vaccine.
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).
History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.
Having serious disease of internal medicine, such as hypertension(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al.
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.

Sites / Locations

Jiangsu Provincial Centre for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HPV Vaccine,135μg/0.5ml

HPV Vaccine,270μg/1.0ml

Arm Description

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

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

Outcomes

Primary Outcome Measures

Solicited local adverse reactions

Solicited local adverse reactions occurred within 7 days after each vaccination;

Solicited systematic adverse reactions

Solicited systematic adverse reactions occurred within 7 days after each vaccination;

Unsolicited adverse events

Unsolicited adverse reactions occurred within 30 days after each vaccination;

Serious adverse events

Serious adverse events occurred throughout the study;

Secondary Outcome Measures

Clinically Relevant Abnormalities in Blood Biochemistry

Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase basophils, total bilirubin, direct bilirubin, indirect bilirubin, creatinine, urea nitrogen. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

Clinically Relevant Abnormalities in Hematological Parameters

Hematological Parameters assessed in blood samples include platelets, red blood cell, hemoglobin and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

Full Information

NCT ID

NCT03813940

First Posted

January 9, 2019

Last Updated

April 7, 2021

Sponsor

Xiamen University

Collaborators

Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03813940

Brief Title

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

Official Title

An Open-Label, Single-Center Phase I Clinical Trial to Estimate Safety of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 3, 2019 (Actual)

Primary Completion Date

August 18, 2019 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xiamen University

Collaborators

Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Condylomata Acuminata, Cervical Cancer

Keywords

human papillomavirus vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPV Vaccine,135μg/0.5ml

Arm Type

Experimental

Arm Description

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

Arm Title

HPV Vaccine,270μg/1.0ml

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

HPV Vaccine,135μg/0.5ml

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

HPV Vaccine,270μg/1.0ml

Intervention Description

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

Primary Outcome Measure Information:

Title

Solicited local adverse reactions

Description

Solicited local adverse reactions occurred within 7 days after each vaccination;

Time Frame

During the 7-day (Day 0-6) period following each vaccination

Title

Solicited systematic adverse reactions

Description

Solicited systematic adverse reactions occurred within 7 days after each vaccination;

Time Frame

During the 7-day (Day 0-6) period following each vaccination

Title

Unsolicited adverse events

Description

Unsolicited adverse reactions occurred within 30 days after each vaccination;

Time Frame

Within 30 days (Day 0-29) after any vaccination

Title

Serious adverse events

Description

Serious adverse events occurred throughout the study;

Time Frame

throughout the study period, an average of 7 months

Secondary Outcome Measure Information:

Title

Clinically Relevant Abnormalities in Blood Biochemistry

Description

Time Frame

Before and the second day after the first and third vaccination

Title

Clinically Relevant Abnormalities in Hematological Parameters

Description

Time Frame

Before and the second day after the first and third vaccination

Other Pre-specified Outcome Measures:

Title

Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody)

Description

To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level on day 0 (before the 1st dose) and one month after dose 3

Time Frame

month 7

Title

Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)

Description

To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level on day 0 (before the 1st dose) and one month after dose 3

Time Frame

month 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Health people aged between 18 and 45 years. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations. Able to comply with the requests of the study. Written informed consent obtained from the participants. Axillary temperature not higher than 37.0°C Men, or non-pregnant women verified by a urine pregnancy test. Exclusion criteria: Pregnant or breastfeeding or plan to be pregnant within 7 months. 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. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. 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. 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. 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. Having the plan to participate another clinical trial during the study period. Received another HPV vaccine. 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). History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years. Having serious disease of internal medicine, such as hypertension(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, Master

Organizational Affiliation

Xiamen University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Yue-Mei Hu, Bachelor

Organizational Affiliation

Jiangsu Provincial Centre for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jiangsu Provincial Centre for Disease Control and Prevention

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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