Condylomata AcuminataPhase 2NCT02710851
Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
A Phase 2 study testing low dosage HPV Vaccine(1:1), low dosage HPV Vaccine(1:2) and high dosage HPV Vaccine(1:1) in people with Condylomata Acuminata, run by Jun Zhang.
Trial summary
This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Condylomata Acuminata
- What is being tested?
- low dosage HPV Vaccine(1:1), low dosage HPV Vaccine(1:2) and high dosage HPV Vaccine(1:1)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2016to 30 Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged between 18 and 55 years.
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- Written informed consent obtained from the participants.
- Able to comply with the requests of the study.
- Axillary temperature not higher than 37.0°C
- Non-pregnancy 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.
- Administration of any attenuated live vaccines within 30 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 (such as HIV carriers), 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.
- Having serious disease of internal medicine, such as hypertension, cardiac disease, diabetes, hyperthyroidism et al.
- Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years.
- Diagnosed coagulant function abnormality (i.e., clotting factors absent, clotting hemorrhagic disease, abnormal platelet function) 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 h a tendency to commit suicide.
- 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.
About this study
Official title: A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
- Conditions
- Condylomata Acuminata
- Being tested
- low dosage HPV Vaccine(1:1), low dosage HPV Vaccine(1:2), high dosage HPV Vaccine(1:1), Hepatitis E vaccine,Hecolin®
- Keywords
- human papillomavirus vaccine, condylomata acuminata
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dosage HPV Vaccine(1:1)Biological
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.
All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
low dosage HPV Vaccine(1:2)Biological
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio.
All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
high dosage HPV Vaccine(1:1)Biological
Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.
All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
Hepatitis E vaccine,Hecolin®Biological
Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.
| Study group | Role | What they receive |
|---|---|---|
| low dosage HPV Vaccine(1:1) | Experimental | Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. Receives: Biological: low dosage HPV Vaccine(1:1) |
| low dosage HPV Vaccine(1:2) | Experimental | Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:2 ratio. Receives: Biological: low dosage HPV Vaccine(1:2) |
| high dosage HPV Vaccine(1:1) | Experimental | Participants in this arm would receive high dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. Receives: Biological: high dosage HPV Vaccine(1:1) |
| Hepatitis E vaccine,Hecolin® | Placebo comparator | Participants in this arm would receive Hepatitis E vaccine,Hecolin® Receives: Biological: Hepatitis E vaccine,Hecolin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody)
Measured: 7 months
Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)
Measured: 7 months
Secondary outcomes (1)
Number of serious adverse events throughout the study
All the serious adverse events throughout the study would be recorded.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start24 Mar 2016
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Responsible party
- Sponsor-investigator, Jun Zhang, Xiamen University
- Investigators
- Jun Zhang, Master, Study chair, Xiamen UniversityYuemei Hu, Bachelor, Principal investigator, Jiangsu center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710851
- Sponsor's protocol ID
- HPV-PRO-005
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2016
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
- ClinicalTrials.gov ID
- NCT02710851
- Acronym / sponsor ID
- HPV-PRO-005
- Conditions
- Condylomata Acuminata
- Keywords
- human papillomavirus vaccine, condylomata acuminata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- 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 the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low dosage HPV Vaccine(1:1) | Experimental | Biological: low dosage HPV Vaccine(1:1)Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. |
| low dosage HPV Vaccine(1:2) | Experimental | Biological: low dosage HPV Vaccine(1:2)Participants in this arm would receive low dosage HPV vaccine with virus-like particles type 6 and 11 at 1:2 ratio. |
| high dosage HPV Vaccine(1:1) | Experimental | Biological: high dosage HPV Vaccine(1:1)Participants in this arm would receive high dosage HPV vaccine with virus-like particles type 6 and 11 at 1:1 ratio. |
| Hepatitis E vaccine,Hecolin® | Placebo comparator | Biological: Hepatitis E vaccine,Hecolin®Participants in this arm would receive Hepatitis E vaccine,Hecolin® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants aged between 18 and 55 years.
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
- Written informed consent obtained from the participants.
- Able to comply with the requests of the study.
- 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.
- Administration of any attenuated live vaccines within 30 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 |
|---|---|---|
| low dosage HPV Vaccine(1:1)Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. | Biological | low dosage HPV Vaccine(1:1) |
| low dosage HPV Vaccine(1:2)Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. | Biological | low dosage HPV Vaccine(1:2) |
| high dosage HPV Vaccine(1:1)Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month. | Biological | high dosage HPV Vaccine(1:1) |
| Hepatitis E vaccine,Hecolin®Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month. | Biological | Hepatitis E vaccine,Hecolin® |
Primary outcome
Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody)
Time frame: 7 months
Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)
Time frame: 7 months
1 secondary outcome
Number of serious adverse events throughout the study
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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
Yuemei Hu, Bachelor principal investigator
Jiangsu center for Disease Prevention and Control
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low dosage HPV Vaccine(1:1), low dosage HPV Vaccine(1:2) and high dosage HPV Vaccine(1:1) in people with Condylomata Acuminata, run by Jun Zhang.
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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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 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?
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?
Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody) (time frame: 7 months). The study lists 2 primary outcomes in all. 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 15 Jun 2023.