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A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

Primary Purpose

HPV Infections

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HPV Vaccine
Placebo
Sponsored by
Shanghai Zerun Biotechnology Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV Infections focused on measuring Human Papilloma Virus, Papillomavirus vaccines, Cervical Cancer, Genital Warts

Eligibility Criteria

9 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy females, 9 to 45 years old (inclusive).
  • 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
  • Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
  • 18 to 45 years old participants: able to prove their legal identities.
  • 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
  • Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period.

Exclusion Criteria:

  • History of cervical cancer or genital warts.
  • History HPV vaccination or history of participation in HPV vaccine trial.
  • History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
  • Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
  • History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination.
  • Medical history of epilepsy, convulsions, seizures , or family history of mental illness.
  • Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination.
  • History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy.
  • Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy
  • Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder
  • Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days.
  • Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination.
  • Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination.
  • Fever before vaccine administration with axillary temperature higher than 37.0°C.
  • Currently breastfeeding, and being pregnant including pregnancy test positive.
  • History of hypertension: Participants of 13 to 45 years of age have their respective systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg; or participants of 9 to 12 years of age demonstrate their respective systolic blood pressure higher than 120 mmHg and/or diastolic blood pressure higher than 80 mmHg.
  • Exhibits of abnormal lab test parameters.
  • Any other factors which might affect any individual to be enrolled in the study according to the investigator's judgment.

Sites / Locations

  • Sichuan Provincial Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPV vaccine

Placebo

Arm Description

Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.

Outcomes

Primary Outcome Measures

Percentage of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Percentage of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Secondary Outcome Measures

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT

Full Information

First Posted
March 28, 2019
Last Updated
April 12, 2023
Sponsor
Shanghai Zerun Biotechnology Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03900572
Brief Title
A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
Official Title
A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zerun Biotechnology Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infections
Keywords
Human Papilloma Virus, Papillomavirus vaccines, Cervical Cancer, Genital Warts

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPV vaccine
Arm Type
Experimental
Arm Description
Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
Intervention Type
Biological
Intervention Name(s)
HPV Vaccine
Intervention Description
Intramuscular injection, 3 doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection, 3 doses
Primary Outcome Measure Information:
Title
Percentage of Subjects Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Time Frame
During a 8-day period (Day 0-7) following each vaccination
Title
Percentage of Subjects Reporting Solicited General Symptoms
Description
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Time Frame
During a 8-day period (Day 0-7) following each vaccination
Title
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
Description
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Time Frame
Within 31 days (Day 0-30) after any vaccination
Title
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Description
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
Throughout the study period (up to Month 12)
Secondary Outcome Measure Information:
Title
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Time Frame
30 days after the third dose (Month 7)
Title
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
Description
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT
Time Frame
30 days after the third dose (Month 7)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy females, 9 to 45 years old (inclusive). 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information. Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants 18 to 45 years old participants: able to prove their legal identities. 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form. Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period. Exclusion Criteria: History of cervical cancer or genital warts. History HPV vaccination or history of participation in HPV vaccine trial. History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock. Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars. History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination. Medical history of epilepsy, convulsions, seizures , or family history of mental illness. Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination. History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy. Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days. Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination. Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination. Fever before vaccine administration with axillary temperature higher than 37.0°C. Currently breastfeeding, and being pregnant including pregnancy test positive. History of hypertension: Participants of 13 to 45 years of age have their respective systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg; or participants of 9 to 12 years of age demonstrate their respective systolic blood pressure higher than 120 mmHg and/or diastolic blood pressure higher than 80 mmHg. Exhibits of abnormal lab test parameters. Any other factors which might affect any individual to be enrolled in the study according to the investigator's judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuecheng LIU, BS
Organizational Affiliation
Sichuan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan Provincial Center for Disease Prevention and Control
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

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