HPV InfectionsPhase 1NCT03900572
A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine
A Phase 1 study testing HPV Vaccine in people with HPV Infections, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females. Read more about this study
- Who is it for?
- Ages 9 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- What is being tested?
- HPV Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2019to 30 Apr 2020
- 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 9 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy females, 9 to 45 years old (inclusive).
- 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
- Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
- 18 to 45 years old participants: able to prove their legal identities.
- 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
- Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period.
Who cannot join
- History of cervical cancer or genital warts.
- History HPV vaccination or history of participation in HPV vaccine trial.
- History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
- Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
- History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination.
- Medical history of epilepsy, convulsions, seizures , or family history of mental illness.
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- Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination.
- History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy.
- Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy
- Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder
- Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days.
- Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination.
- Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination.
- Fever before vaccine administration with axillary temperature higher than 37.0°C.
- Currently breastfeeding, and being pregnant including pregnancy test positive.
- History of hypertension: Participants of 13 to 45 years of age have their respective systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg; or participants of 9 to 12 years of age demonstrate their respective systolic blood pressure higher than 120 mmHg and/or diastolic blood pressure higher than 80 mmHg.
- Exhibits of abnormal lab test parameters.
- Any other factors which might affect any individual to be enrolled in the study according to the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provincial Center for Disease Prevention and Control
Chengdu, Sichuan, 610041
About this study
Official title: A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females
A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
- Conditions
- HPV Infections
- Being tested
- HPV Vaccine, Placebo
- Keywords
- Human Papilloma Virus, Papillomavirus vaccines, Cervical Cancer, Genital Warts
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV VaccineBiological
Intramuscular injection, 3 doses
PlaceboDrug
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine | Experimental | Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. Receives: Biological: HPV Vaccine |
| Placebo | Placebo comparator | Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Measured: During a 8-day period (Day 0-7) following each vaccination
Percentage of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Measured: During a 8-day period (Day 0-7) following each vaccination
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Measured: Within 31 days (Day 0-30) after any vaccination
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Throughout the study period (up to Month 12)
Secondary outcomes (2)
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as a participant who was anti-HPV seronegative at Day 0 (before vaccination) and became seropositive 30days after the third dose (Month 7).
Measured: 30 days after the third dose (Month 7)
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 specific antibodies GMT
Measured: 30 days after the third dose (Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start9 Mar 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionsStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuecheng LIU, BS, Principal investigator, Sichuan Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900572
- Sponsor's protocol ID
- 312-HPV-2001
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2019
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females
- ClinicalTrials.gov ID
- NCT03900572
- Acronym / sponsor ID
- 312-HPV-2001
- Conditions
- HPV Infections
- Keywords
- Human Papilloma Virus, Papillomavirus vaccines, Cervical Cancer, Genital Warts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 3 Apr 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.
A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine | Experimental | Biological: HPV VaccineSubjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received 3 doses of Placebo according to a 0, 2, 6-month schedule. |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy females, 9 to 45 years old (inclusive).
- 9 to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
- Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
- 18 to 45 years old participants: able to prove their legal identities.
- 18 to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
Key exclusion criteria (18 listed)
- History of cervical cancer or genital warts.
- History HPV vaccination or history of participation in HPV vaccine trial.
- History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
- Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
- History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past 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 VaccineIntramuscular injection, 3 doses | Biological | HPV vaccine |
| PlaceboIntramuscular injection, 3 doses | Drug | Placebo |
Primary outcome
Percentage of Subjects Reporting Solicited Local Symptoms
Time frame: During a 8-day period (Day 0-7) following each vaccination
Solicited local symptoms assessed including pain, redness, swelling, induration and itching.
Percentage of Subjects Reporting Solicited General Symptoms
Time frame: During a 8-day period (Day 0-7) following each vaccination
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Day 0-30) after any vaccination
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Percentage of Subjects Reporting Serious Adverse Events (SAE)
Time frame: Throughout the study period (up to Month 12)
Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
2 secondary outcomes
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time frame: 30 days after the third dose (Month 7)
Geometric Mean Titers (GMT) of HPV serotype-specific antibody
Time frame: 30 days after the third dose (Month 7)
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 13 Apr 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.
Xuecheng LIU, BS principal investigator
Sichuan Provincial Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPV Vaccine in people with HPV Infections, run by Shanghai Zerun Biotechnology 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 18 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 13 Apr 2023. 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 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?
Percentage of Subjects Reporting Solicited Local Symptoms (time frame: During a 8-day period (Day 0-7) 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?
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 Apr 2023.