Condylomata AcuminataPhase 1NCT02405520
Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
A Phase 1 study testing low dosage HPV Vaccine, medium dosage HPV Vaccine and high dosage HPV Vaccine in people with Condylomata Acuminata, run by Jun Zhang.
Trial summary
This phase I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 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, medium dosage HPV Vaccine and high dosage HPV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2015to 20 May 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health people 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 was obtained from the participants.
- Able to comply with the requests of the study.
- 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.
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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.
- 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 (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 Phase I Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
This phase I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.
- Conditions
- Condylomata Acuminata
- Being tested
- low dosage HPV Vaccine, medium dosage HPV Vaccine, high dosage HPV Vaccine, Aluminium Adjuvant
- 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 VaccineBiological
Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
medium dosage HPV VaccineBiological
Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
high dosage HPV VaccineBiological
Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
Aluminium AdjuvantBiological
Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| low dosage HPV Vaccine | Experimental | Participants in this arm would receive low dosage of HPV vaccines. Receives: Biological: low dosage HPV Vaccine |
| medium dosage HPV Vaccine | Experimental | Participants in this arm would receive medium dosage of HPV vaccines. Receives: Biological: medium dosage HPV Vaccine |
| high dosage HPV Vaccine | Experimental | Participants in this arm would receive high dosage of HPV vaccines. Receives: Biological: high dosage HPV Vaccine |
| Placebo | Placebo comparator | Participants in this arm would receive placebo (Aluminium Adjuvant). Receives: Biological: Aluminium Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure adverse reactions/events throughout the study
With composite measure: Measure solicited local/systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure blood, liver and kidney function changes pre- and 2 days post vaccination; Measure serious adverse events occurred throughout the study
Measured: 10 month
Secondary outcomes (1)
Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations.
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start26 Mar 2015
- Primary completion5 Jun 2019
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 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 UniversityZhao-Jun Mo, Master, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and ControlTing Wu, Ph. D, Study director, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405520
- Sponsor's protocol ID
- HPV-PRO-004
- Status last verified
- May 2022
- First submitted
- 25 Mar 2015
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Calvin Devadasan JD, Nithyanandhan K, Fletcher GJ, Kannangai R, Abraham P. HPV vaccines - A game changer for preventing HPV-related cancers. Indian J Med Microbiol. 2025 May-Jun;55:100847. doi: 10.1016/j.ijmmb.2025.100847. Epub 2025 Apr 10.
PubMed 40221095Mo ZJ, Bi ZF, Sheng W, Chen Q, Huang T, Li MQ, Cui XL, Wangjiang YH, Lin BZ, Zheng FZ, Sun G, Li YF, Zheng Y, Zhuang SJ, Su YY, Pan HR, Huang SJ, Wu T, Zhang J, Xia NS. Safety and immunogenicity of an Escherichia coli-produced bivalent human papillomavirus type 6/11 vaccine: A dose-escalation, randomized, double-blind, placebo-controlled phase 1 trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2092363. doi: 10.1080/21645515.2022.2092363. Epub 2022 Jul 14.
PubMed 35834812
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
- ClinicalTrials.gov ID
- NCT02405520
- Acronym / sponsor ID
- HPV-PRO-004
- Conditions
- Condylomata Acuminata
- Keywords
- human papillomavirus vaccine, condylomata acuminata
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Xiamen Innovax Biotech Co., Ltd, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 1 Apr 2015 (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 I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.
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 | Experimental | Biological: low dosage HPV VaccineParticipants in this arm would receive low dosage of HPV vaccines. |
| medium dosage HPV Vaccine | Experimental | Biological: medium dosage HPV VaccineParticipants in this arm would receive medium dosage of HPV vaccines. |
| high dosage HPV Vaccine | Experimental | Biological: high dosage HPV VaccineParticipants in this arm would receive high dosage of HPV vaccines. |
| Placebo | Placebo comparator | Biological: Aluminium AdjuvantParticipants in this arm would receive placebo (Aluminium Adjuvant). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Health people 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 was 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 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 |
|---|---|---|
| low dosage HPV VaccineParticipants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological | low dosage HPV Vaccine |
| medium dosage HPV VaccineParticipants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological | medium dosage HPV Vaccine |
| high dosage HPV VaccineParticipants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses. | Biological | high dosage HPV Vaccine |
| Aluminium AdjuvantParticipants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses. | Biological | Placebo |
Primary outcome
Measure adverse reactions/events throughout the study
Time frame: 10 month
With composite measure: Measure solicited local/systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure blood, liver and kidney function changes pre- and 2 days post vaccination; Measure serious adverse events occurred throughout the study
1 secondary outcome
Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations.
Time frame: 7 month
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 24 May 2022.
- Derived from this study: PubMed 40221095Calvin Devadasan JD, Nithyanandhan K, Fletcher GJ, Kannangai R, Abraham P. HPV vaccines - A game changer for preventing HPV-related cancers. Indian J Med Microbiol. 2025 May-Jun;55:100847. doi: 10.1016/j.ijmmb.2025.100847. Epub 2025 Apr 10.
- Derived from this study: PubMed 35834812Mo ZJ, Bi ZF, Sheng W, Chen Q, Huang T, Li MQ, Cui XL, Wangjiang YH, Lin BZ, Zheng FZ, Sun G, Li YF, Zheng Y, Zhuang SJ, Su YY, Pan HR, Huang SJ, Wu T, Zhang J, Xia NS. Safety and immunogenicity of an Escherichia coli-produced bivalent human papillomavirus type 6/11 vaccine: A dose-escalation, randomized, double-blind, placebo-controlled phase 1 trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2092363. doi: 10.1080/21645515.2022.2092363. Epub 2022 Jul 14.
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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
Zhao-Jun Mo, Master principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Ting Wu, Ph. D study director
Xiamen University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing low dosage HPV Vaccine, medium dosage HPV Vaccine and high dosage HPV Vaccine 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: finished, as of the sponsor's last update on 24 May 2022. 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?
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?
Measure adverse reactions/events throughout the study (time frame: 10 month). 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 NCT02405520, which also lists 2 linked publications.
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 24 May 2022.