Random, Double Blind, Placebo Controlled Phase I Clinical Trials to Estimate the Safety and Preliminary Immunogenicity of Tetravalent Recombinant Human Papilloma Virus Vaccine (6,11,16,18 Type)(Hansenula Polymorpha) in Women of 9 to 30 Years Old and Men of 9 to 17 Years Old
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Enrollment
- 135
- Primary Endpoint
- Evaluate the Rate of Adverse reactions of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17
- Last Updated
- 9 years ago
Overview
Brief Summary
This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17 years old and preliminarily explore the immunogenicity.
135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15 women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30 women and 30 men in vaccine group and 15 women and 15 men in placebo group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Requirements of age: males of 9 to 17 years old, females of 9 to 30 years old.
- •Willing to provide the statutory certificate of identity.
- •For subjects of 18 to 30 years old, they should be able to understand the clinical trials and agreed to sign the informed consent; for subjects of 9 to 17 years old, their guardian should be able to understand the clinical trial, and sign informed consent together with subjects.
- •Female subjects have no pregnancy and birth plans in the 7 months after being enrolled, and agree to take effective contraception during this period.
Exclusion Criteria
- •People with history of cervical cancer or HPV infection related diseases such as condyloma
- •People with a history of severe allergic reactions requiring medical intervention (such as garget, difficult breathing, hypotension or shock)
- •People with a history of serious side effects after vaccination or severe allergic reaction to food or drugs
- •People with epilepsy or a history of mental illness
- •People in immune deficiency or diagnosed with 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, people with immunosuppressive therapy in the past six months.
- •People with serious liver or kidney disease, cardiovascular disease, severe hypertension, diabetes, cancer, all kinds of infectious disease and acute disease or in acute attack period of chronic diseases
- •Asplenia, functional asplenia, and any situation leading to asplenia or splenectomize.
- •People diagnosed by doctors with coagulation dysfunction (such as the lack of clotting factors, disorders of blood coagulation and blood platelet disorders), apparent bruises or blood coagulation disorders;
- •People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination.
- •People get any vaccine within 14 days before the trial.
Outcomes
Primary Outcomes
Evaluate the Rate of Adverse reactions of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17
Time Frame: 30 days
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
Secondary Outcomes
- Evaluate the seroconversion rate of HPV antibodies in serum after vaccination.(30 days)