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OpenTrials
Completed

NCT Number: NCT03935204

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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, 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.
  • 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.

Treatment and study plan

HPV Vaccine,270μg/1.0ml

Biological

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

Placebo

Biological

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

Other names: aluminium adjuvant

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)

    Time frame: month 7

    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

Secondary outcomes

  1. Solicited local adverse reactions

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

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

  2. Solicited systematic adverse reactions

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

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

  3. Unsolicited adverse events

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

    Unsolicited adverse reactions occurred within 30 days after each vaccination;

  4. Serious adverse events

    Time frame: throughout the study period, an average of 7 months

    Serious adverse events occurred throughout the study;

Other 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 IgG antibody)

    Time frame: month 7

    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

  2. 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)

    Time frame: month 1,2 and 6

    To detect the anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing and IgG antibody level of a immunogenicity subgroup at month 1,2 and 6.

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

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

Registry information

Official study title

An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
May 2, 2019
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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