Condylomata AcuminataPhase 2NCT03935204
Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
A Phase 2 study testing HPV Vaccine,270μg/1.0ml in people with Condylomata Acuminata and Cervical Cancer, run by Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condylomata Acuminata, Cervical Cancer
- What is being tested?
- HPV Vaccine,270μg/1.0ml
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 627 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2019to 1 Apr 2021
- Phase
- Phase 2
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official 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
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.
- Conditions
- Condylomata Acuminata, Cervical Cancer
- Being tested
- HPV Vaccine,270μg/1.0ml, Placebo
- 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,270μg/1.0mlBiological
HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
PlaceboBiological
Also called aluminium adjuvant
Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
| Study group | Role | What they receive |
|---|---|---|
| HPV Vaccine,270μg/1.0ml | Experimental | Participants in this arm would receive 270μg/1.0ml HPV vaccines. Receives: Biological: HPV Vaccine,270μg/1.0ml |
| Placebo | Placebo comparator | Participants in this arm would receive 1.0ml aluminium adjuvant. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Measured: month 7
Secondary outcomes (4)
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
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
Unsolicited adverse events
Unsolicited adverse reactions occurred within 30 days after each vaccination;
Measured: Within 30 days (Day 0-29) after any vaccination
Serious adverse events
Serious adverse events occurred throughout the study;
Measured: throughout the study period, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start13 May 2019
- Primary completion18 Oct 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, Master, Study chair, Xiamen UniversityYue-Mei Hu, Bachelor, Principal investigator, Jiangsu Provincial Centre for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935204
- Sponsor's protocol ID
- HPV-PRO-008
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03935204
- Acronym / sponsor ID
- HPV-PRO-008
- Conditions
- Condylomata Acuminata, Cervical Cancer
- Keywords
- human papillomavirus vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Study start
- 13 May 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV Vaccine,270μg/1.0ml | Experimental | Biological: HPV Vaccine,270μg/1.0mlParticipants in this arm would receive 270μg/1.0ml HPV vaccines. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants in this arm would receive 1.0ml aluminium adjuvant. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV Vaccine,270μg/1.0mlHPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. | Biological | HPV Vaccine,270μg/1.0ml |
| PlaceboAlso: aluminium adjuvantAluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. | Biological | Placebo |
Primary outcome
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
4 secondary outcomes
Solicited local adverse reactions
Time frame: During the 7-day (Day 0-6) period following each vaccination
Solicited systematic adverse reactions
Time frame: During the 7-day (Day 0-6) period following each vaccination
Unsolicited adverse events
Time frame: Within 30 days (Day 0-29) after any vaccination
Serious adverse events
Time frame: throughout the study period, an average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, Master study chair
Xiamen University
Yue-Mei Hu, Bachelor principal investigator
Jiangsu Provincial Centre for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.