Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17

NCT02888418 | Unknown Phase 1

• 1 other identifier: cycdc2016-4
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Keywords

vaccine; safety; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Evaluate the Rate of Adverse reactions of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17

  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.

  30 days

Secondary Outcomes (1)

• Evaluate the seroconversion rate of HPV antibodies in serum after vaccination.

  30 days

Study Arms (6)

One dose of HPV vaccine in women aged 18 to 30

EXPERIMENTAL

One dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women aged 18 to 30.

Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)

Placebo in women aged 18 to 30

PLACEBO COMPARATOR

Placebo in women aged 18 to 30.

Biological: placebo

One dose of HPV vaccine in women aged 9 to 17

EXPERIMENTAL

One dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women aged 9 to 17.

Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)

Placebo in women aged 9 to 17

PLACEBO COMPARATOR

Placebo in women aged 9 to 17.

Biological: placebo

One dose of HPV vaccine in men aged 9 to 17

EXPERIMENTAL

One dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in men aged 9 to 17.

Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)

Placebo in men aged 9 to 17

PLACEBO COMPARATOR

Placebo in men aged 9 to 17.

Biological: placebo

Interventions

Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) BIOLOGICAL

Injection vaccine produced by Beijing institute of biological products co., LTD, containing HPV antigen protein, 120μg/0.5ml/bottle

One dose of HPV vaccine in men aged 9 to 17; One dose of HPV vaccine in women aged 18 to 30; One dose of HPV vaccine in women aged 9 to 17

placebo BIOLOGICAL

Placebo in men aged 9 to 17; Placebo in women aged 18 to 30; Placebo in women aged 9 to 17

Eligibility Criteria

• Age: 9 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• People with fever before vaccination, axillary temperature higher than 37.0 ℃.
• Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant.
• People with abnormal laboratory index. (slight abnormity is except if judged with no clinical significance by doctors.)
• People has gotten HPV vaccine before; people has used or plans to use other vaccine or unregistered products (drugs or vaccines) within 30 days before the first dose; people plans to participate in other clinical trials within 6 months after this clinical trial.
• According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials.

Sponsors & Collaborators

• Beijing Chaoyang District Centre for Disease Control and Prevention: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 5, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 5, 2016

Record last verified: 2016-08