AzTrials
AzTrials

Condylomata AcuminataPhase 1NCT03813940

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

A Phase 1 study testing HPV Vaccine,135μg/0.5ml and HPV Vaccine,270μg/1.0ml in people with Condylomata Acuminata and Cervical Cancer, run by Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I clinical study was designed to evaluate the 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Condylomata Acuminata, Cervical Cancer
What is being tested?
HPV Vaccine,135μg/0.5ml and HPV Vaccine,270μg/1.0ml
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
3 Jan 2019to 1 Apr 2021
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Health people 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
  • Men, or non-pregnant women verified by a urine pregnancy test.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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(systolic blood pressure > 140mmHg or diastolic blood pressure >90mmHg), cardiac disease, diabetes, hyperthyroidism et al.
  • Diagnosed coagulant function abnormality or blood coagulation disorder. 14) The results of blood routine test and blood biochemical test were abnormal. The grade was 2 or above.
  • 15) 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.
  • 16) 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.
  • 17) 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Centre for Disease Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: An Open-Label, Single-Center Phase I Clinical Trial to Estimate Safety 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

This phase I clinical study was designed to evaluate the 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.

Read the detailed description

The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the participants would be actively monitored for adverse reactions/events for 1 month after each injection. SAE during the trial were followed up. And blood, liver and kidney function changes will be monitored before and 2 days after the first and third vaccination. Serum samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity as exploratory analysis.

Being tested
HPV Vaccine,135μg/0.5ml, HPV Vaccine,270μg/1.0ml
Keywords
human papillomavirus vaccine
Medical subject headings
Condylomata Acuminata, Uterine Cervical Neoplasms

What participants receive

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

  • HPV Vaccine,135μg/0.5mlBiological

    HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule

  • HPV Vaccine,270μg/1.0mlBiological

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

Study groups in NCT03813940
Study groupRoleWhat they receive
HPV Vaccine,135μg/0.5mlExperimentalParticipants in this arm would receive 135μg/0.5ml HPV vaccines
Receives: Biological: HPV Vaccine,135μg/0.5ml
HPV Vaccine,270μg/1.0mlExperimentalParticipants in this arm would receive 270μg/1.0ml HPV vaccines.
Receives: Biological: HPV Vaccine,270μg/1.0ml

What is being measured

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

  1. Solicited local adverse reactions

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

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

  2. Solicited systematic adverse reactions

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

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

  3. Unsolicited adverse events

    Unsolicited adverse reactions occurred within 30 days after each vaccination;

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

  4. Serious adverse events

    Serious adverse events occurred throughout the study;

    Measured: throughout the study period, an average of 7 months

Secondary outcomes (2)

  1. Clinically Relevant Abnormalities in Blood Biochemistry

    Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase basophils, total bilirubin, direct bilirubin, indirect bilirubin, creatinine, urea nitrogen.

    Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

    Measured: Before and the second day after the first and third vaccination

  2. Clinically Relevant Abnormalities in Hematological Parameters

    Hematological Parameters assessed in blood samples include platelets, red blood cell, hemoglobin and white blood cells.

    Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

    Measured: Before and the second day after the first and third vaccination

Timeline

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

  1. First posted23 Jan 2019
  2. Study start3 Jan 2019
  3. Primary completion18 Aug 2019
  4. Study completion1 Apr 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03813940
Sponsor's protocol ID
HPV-PRO-007
Status last verified
Apr 2021
First submitted
9 Jan 2019
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chu K, Bi ZF, Huang WJ, Li YF, Zhang L, Yang CL, Jiang HM, Zang X, Chen Q, Liu DL, Pan HX, Huang Y, Zheng FZ, Zhang QF, Sun G, Su YY, Huang SJ, Pan HR, Wu T, Hu YM, Zhang J, Zhu FC, Xia NS. Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial. Lancet Reg Health West Pac. 2023 Mar 13;34:100731. doi: 10.1016/j.lanwpc.2023.100731. eCollection 2023 May.

    PubMed 37283969

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HPV Vaccine,135μg/0.5ml and HPV Vaccine,270μg/1.0ml in people with Condylomata Acuminata and Cervical Cancer, run by Xiamen University at 1 site in China.

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 6 inclusion and 16 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: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Solicited local adverse reactions (time frame: During the 7-day (Day 0-6) period following each vaccination). The study lists 4 primary outcomes in all. 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 NCT03813940, which also lists 1 linked publication.

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 8 Apr 2021.

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