Human Papilloma Virus Infection Type 16Phase 4NCT05415345
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin
A Phase 4 study testing Cecolin and Hecolin in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli) Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection
- What is being tested?
- Cecolin and Hecolin
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 10 Jun 2023
- Phase
- Phase 4
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged between 18 and 25 years (including 18 and 25 years) on the day of enrollment
- Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
- Willing to participate in this study and sign informed consent form
- Able to understand this study information and willing to comply with all study requirements
- Axillary temperature ≤37.0 °C
- Negative urine pregnancy test
Who cannot join
- Women who are pregnant or breastfeeding or who plan to get pregnant within the next seven 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 during the study period
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study
- 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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- Plan to participate in another clinical study at the same time during the study
- Previous vaccination against HPV or HEV
- Immunodeficiency (such as HIV positive), 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, which has been unstable for the past two years and requires urgent treatment, hospitalization, oral or intravenous corticosteroid
- Complicated with serious medical diseases, such as hypertension, heart disease, diabetes, hyperthyroidism, etc
- Medical diagnosis of abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders
- Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years before abstinence or simple epilepsy that did not require treatment for the past 3 years
- Past or present mental illness due to a psychological condition that does not comply with the requirements of the study; mental illness that has not been well controlled in the past two years; mental illness requiring medication; and suicidal tendency in the past five 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
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, 310000
About this study
Official title: Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Read the detailed description
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection
- Being tested
- Cecolin, Hecolin
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CecolinBiological
Bivalent HPV Vaccine
HecolinBiological
Hepatitis E vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months. Receives: Biological: Cecolin; Biological: Hecolin |
| Group B | Active comparator | Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months. Receives: Biological: Cecolin |
| Group C | Active comparator | Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months. Receives: Biological: Hecolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the concentration of IgG antibodies to HPV-16
Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B
Measured: At 7 months after first dose
evaluate the concentration of IgG antibodies to HPV-18
Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B
Measured: At 7 months after first dose
evaluate the concentration of IgG antibodies to HEV
detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C
Measured: At 7 months after first dose
Secondary outcomes (3)
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Measured: During the 7-day period following each vaccination
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Measured: Within 30 days after any vaccination
Serious adverse events occurred throughout the study
Safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start25 Oct 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus Infection Type 16Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Innovax Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Zhenggang Jiang, Principal investigator, Zhejiang Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415345
- Sponsor's protocol ID
- PROPMHP001
- Status last verified
- May 2022
- First submitted
- 27 May 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Immunogenicity and Safety of Co-immunization With Recombinant Human Papillomavirus 16/18 Bivalent Vaccine and Hepatitis E Vaccine
- ClinicalTrials.gov ID
- NCT05415345
- Acronym / sponsor ID
- PROPMHP001
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Provincial Center for Disease Control and Prevention
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 13 Jun 2022 (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.
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Detailed description
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Cecolin, Biological: HecolinParticipants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months. |
| Group B | Active comparator | Biological: CecolinParticipants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months. |
| Group C | Active comparator | Biological: HecolinParticipants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, aged between 18 and 25 years (including 18 and 25 years) on the day of enrollment
- Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
- Willing to participate in this study and sign informed consent form
- Able to understand this study information and willing to comply with all study requirements
- Axillary temperature ≤37.0 °C
Key exclusion criteria (16 listed)
- Women who are pregnant or breastfeeding or who plan to get pregnant within the next seven 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 during the study period
- Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study
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 |
|---|---|---|
| CecolinBivalent HPV Vaccine | Biological | Group A, Group B |
| HecolinHepatitis E vaccine | Biological | Group A, Group C |
Primary outcome
evaluate the concentration of IgG antibodies to HPV-16
Time frame: At 7 months after first dose
Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B
evaluate the concentration of IgG antibodies to HPV-18
Time frame: At 7 months after first dose
Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B
evaluate the concentration of IgG antibodies to HEV
Time frame: At 7 months after first dose
detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C
3 secondary outcomes
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Time frame: During the 7-day period following each vaccination
Adverse events/reactions occurred within 30 days after each vaccination
Time frame: Within 30 days after any vaccination
Serious adverse events occurred throughout the study
Time frame: Up to 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
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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.
Zhenggang Jiang principal investigator
Zhejiang Provincial Center 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 4 study testing Cecolin and Hecolin in people with Human Papilloma Virus Infection Type 16 and Human Papilloma Virus Infection Type 18, run by Xiamen Innovax Biotech Co., Ltd 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 concentration of IgG antibodies to HPV-16 (time frame: At 7 months after first dose). The study lists 3 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 NCT05415345, 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 13 Jun 2022.