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

NCT03935204 | Completed Phase 2

• 1 other identifier: HPV-PRO-008
• Study Type: interventional
• Target: 627
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical study was designed to evaluate the immunogenicity and 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.

Conditions

Condylomata Acuminata; Cervical Cancer

Keywords

human papillomavirus vaccine

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  month 7

Secondary Outcomes (4)

• Solicited local adverse reactions

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

• Solicited systematic adverse reactions

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

• Unsolicited adverse events

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

• Serious adverse events

  throughout the study period, an average of 7 months

Other Outcomes (2)

• 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)

  month 7

• Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations in a immunogenicity subgroup at Months 1,2 and 7 (type specific neutralizing antibody and IgG antibody)

  month 1,2 and 6

Study Arms (2)

HPV Vaccine,270μg/1.0ml

EXPERIMENTAL

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

Biological: HPV Vaccine,270μg/1.0ml

Placebo

PLACEBO COMPARATOR

Participants in this arm would receive 1.0ml aluminium adjuvant.

Biological: Placebo

Interventions

HPV Vaccine,270μg/1.0ml BIOLOGICAL

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

HPV Vaccine,270μg/1.0ml

Placebo BIOLOGICAL

Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Also known as: aluminium adjuvant

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Health women 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
• Non-pregnant women verified by a urine pregnancy test.

You may not qualify if:

• 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, cardiac disease, diabetes, hyperthyroidism et al.
• Diagnosed coagulant function abnormality or blood coagulation disorder.
• 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.
• 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.

Sponsors & Collaborators

• Xiamen University: lead
• Xiamen Innovax Biotech Co., Ltd: collaborator
• Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Condylomata Acuminata; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Jun Zhang, Master

  Xiamen University

  STUDY CHAIR

• Yue-Mei Hu, Bachelor

  Jiangsu Provincial Centre for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: May 13, 2019
• Primary Completion: October 18, 2019
• Study Completion: April 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (1)