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Cervical CancerPhase 1NCT02888418

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

A Phase 1 study testing Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in people with Cervical Cancer, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
No sites listed yet
Study dates
Oct 2016to Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 40Show fewer
  • 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.
  • The exclusion criteria for the second and third dose：
  • Urine pregnancy test are positive before vaccination.
  • Receiving blood products or other studied drugs after enrollment.
  • Suffering from serious illness or with serious adverse events that require continuous treatment.
  • Situations need to be excepted according to the judgement of researchers or the confirmation of Ethics Committee.
  • Newly occurred or discovered people that does not meet exclusion criteria of first dose after the first vaccination.
  • Delayed immunization:
  • Acute infectious disease, temperature being over 37.0 ℃or acute attack of chronic disease before inoculation.
  • Physical examination is abnormal on the day of vaccination.
  • Researchers think that the subjects belong to other temporary contraindications of vaccination.
  • Withdrawal criteria:
  • Any situation in exclusion criteria after enrollment.
  • People who suffers from diseases that need to be treated by immune inhibitors should be dropped out, in case of the harm of diseases that need to be treated by immune inhibitors.
  • Serious adverse events: events that need or prolong hospitalization, disability, threatening lives or death. Researchers decide whether to quit the trial.
  • Against the plan and deviation from the plan:
  • against the plan events
  • no appropriate informed consent for the subjects;
  • the subjects get into the research while do not meet the inclusion criteria or meet the exclusion criteria.
  • subjects use the vaccines that are not preserved as requested.
  • serious adverse event (SAE) does not be reported or timely reported.
  • subjects proactively use forbidden drugs (anti-allergic drug, antipyretic and analgesic, accepting systemic corticosteroids more than 2 mg/kg/day by intramuscular injection, oral or intravenous administration, continuing more than 14 days, or other immune inhibitors).
  • deviation from the plan
  • exceeding the Window of supervision.
  • the blood sample of subjects does not be collected or sample quantity is not enough to finish the test.
  • no enough interval with other vaccines.

About this study

Official title: 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

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
Being tested
Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha), placebo
Keywords
vaccine, safety, immunogenicity
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • placeboBiological

Study groups in NCT02888418
Study groupRoleWhat they receive
One dose of HPV vaccine in women aged 18 to 30ExperimentalOne dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women aged 18 to 30.
Receives: Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)
Placebo in women aged 18 to 30Placebo comparatorPlacebo in women aged 18 to 30.
Receives: Biological: placebo
One dose of HPV vaccine in women aged 9 to 17ExperimentalOne dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women aged 9 to 17.
Receives: Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)
Placebo in women aged 9 to 17Placebo comparatorPlacebo in women aged 9 to 17.
Receives: Biological: placebo
One dose of HPV vaccine in men aged 9 to 17ExperimentalOne dose of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in men aged 9 to 17.
Receives: Biological: Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)
Placebo in men aged 9 to 17Placebo comparatorPlacebo in men aged 9 to 17.
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (1)

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

    The seroconversion rate will be evaluated at 30 days after vaccination.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888418
Sponsor's protocol ID
cycdc2016-4
Status last verified
Aug 2016
First submitted
11 Aug 2016
Last updated
5 Sep 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in people with Cervical Cancer, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02888418.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.

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