Human Papillomavirus InfectionPhase 1NCT05680454
A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine
A Phase 1 study testing Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) and Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc at 1 site in China.
Trial summary
This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45 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
- Human Papillomavirus Infection
- What is being tested?
- Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) and Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 10 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stage 1:
- Female subjects 27-45 years of age (inclusive of 27 and 45 years of age);
- Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
- Subjects who understand and agree to comply with the study procedures and provide written informed consent;
- Subjects who are able to comply with protocol-specified requirements;
- Subjects with negative urine pregnancy test result at screening;
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- Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc.), or subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose and throughout the study;
- Subjects with axillary temperature≤37.0℃.
- Stage 2:
- Female subjects 18-26 years of age (inclusive of 18 and 26 years of age);
- Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
- Subjects who understand and agree to comply with the study procedures and provide written informed consent;
- Subjects who are able to comply with protocol-specified requirements;
- Subjects with negative urine pregnancy test result at screening;
- Subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose and throughout the study;
- Subjects with axillary temperature≤37.0℃.
Who cannot join
- The same exclusion criteria apply to both stage 1 and stage 2
- Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
- Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
- Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
- Women who have known allergy history or who are allergic to any component of the interventions, such as penicillin and amikacin;
- Women with a history of severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
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- Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;
- Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past two years;
- Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;
- Women with a history of thyroidectomy or thyroid diseases that required medical care within the past 12 months.;
- Women with serious angioedema episodes within the past 3 years or requiring medical care over the past 2 years;
- Women who have hypertension over 145/95 mm Hg at enrolment despite being treated by medication;
- Women with coagulation disorders as diagnosed by a doctor (e.g. coagulation factor deficiency, coagulopathy, or platelet disorder) or coagulation difficulty;
- Women with active malignancy, or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study;
- Women with a history of epilepsy other than epilepsy with febrile seizures under two years of age, epilepsy secondary to alcohol use 3 years prior to alcohol withdrawal, or a singular epileptic seizure not requiring treatment within the past 3 years;
- Women with the condition of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen;
- Women with a history of systematic chemotherapy in the past 5 years, a history of immunosuppressive therapy and cytotoxic therapy, and treatment with inhaled corticosteroids within the past 6 months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis), and women who received blood products in the 3 months prior to vaccination with the interventions;
- Women who received a live attenuated vaccine during the 28 days prior to vaccination with the interventions; Women who received a subunit or inactivated vaccine, such as pneumococcal vaccine, or underwent antianaphylactic treatment during the 14 days prior to vaccination with the interventions;
- Women who received a subunit or inactivated vaccine, such as pneumococcal vaccine, or underwent antianaphylactic treatment during the 14 days prior to vaccination with the interventions;
- Women who are currently on an anti-TB prophylaxis or therapy;
- Women who had fever (with axillary temperature≥38.0℃) during the 3 days prior to vaccination with the interventions or onset of any acute illness that required the use of antibiotics and antiviral treatment within the past 5 days;
- Women with psychiatric conditions that preclude compliance with the protocol, or women with past or present psychoses, past or present bipolar disorder that has not been well controlled over the past 2 years, or women who are on medication for psychoses, or women who had suicidal thoughts/tendency in the past 5 years prior to enrolment;
- Women with any medical, psychological or social conditions, or for occupational reasons or otherwise as judged by the principal investigator, that preclude participation in the study, or compromise a subject's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial in Healthy Chinese Women Ages 18-45 to Evaluate the Safety and Tolerability Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)
This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45
Read the detailed description
This is a single-centre, dose-escalating, randomized, blinded and active controlled trial in healthy Chinese women ages 18-45. The positive control is Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine.
The trial will be conducted in two stages:
Stage 1: A single-center, open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form, respectively, to preliminarily evaluate the safety profile of the investigational vaccine.
First, the 20 subjects in the mid-dosage group will be sequentially enrolled as two batches of 5 and 15 subjects, respectively, at an enrolment interval of no less than 3 days. One week after vaccinating all the 20 subjects in the mid-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 20 subjects for the higher dosage-group will be enrolled subsequently in the same manner as those in the mid-dosage group.
Subjects in each dosage group will receive a 3-dose regimen at months 0, 2 and 6. Safety of the investigational vaccine will be assessed for 30 days following each injection, and SAE will be reported for the duration of the study. In total there will be 12 scheduled visits for subjects in each dosage group throughout the study.
One week after vaccinating all the 40 subjects in stage 1, if the safety profile of the investigational vaccine is confirmed to be acceptable, the study may proceed to stage 2.
Stage 2:
A phase I, single-center, dose-escalating, randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively (that is, 10 of the subjects in each dosage group will receive the positive control).
Firstly, the 40 subjects in the low-dosage group will be sequentially enrolled as four batches of 5, 10, 10 and 15 subjects, respectively, at an enrolment interval of no less than 3 days to get the first dose of the low-dosage investigational vaccine or positive control. Then, one week after vaccinating all the 40 subjects in the low-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 40 subjects will be enrolled subsequently into the mid-dosage group in the same manner as those in the low-dosage group. Again, one week after vaccinating the 40 subjects in the mid-dosage group, if the safety profile of the investigational vaccine continues to be acceptable, another group of 40 subjects receiving the high-dosage investigational vaccine or positive control will be enrolled subsequently in the same manner as those in the low-dosage group.
In both stage 1 and stage 2 of the phase I study, 5 ml of non-anticoagulative blood will be collected from trial subjects prior to dose 1 and at Month 3 and Month 7 post dose 1 to determine the levels of neutralizing antibodies and IgG antibodies to the vaccine HPV types.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli), Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine
- Keywords
- CIN, VIN, VaIN, AIN, Cervical cancer, Vaginal cancer, vulvar cancer, Anal cancer, Genital warts
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Anus Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)Biological
For Low-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.
Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) VaccineBiological
A 3-dose regimen administered at months 0, 2 and 6.
| Study group | Role | What they receive |
|---|---|---|
| The Group of Investigational Vaccine | Experimental | For Low-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 20μg、40μg、40μg、20μg、20μg、20μg、20μg、20μg, and 20μg respectively, totaling 220μg of antigens.
For High-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg、40μg、80μg、60μg、30μg、30μg、30μg、30μg and 30μg respectively, totaling 360μg of antigens.
For Mid-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg、40μg、60μg、40μg、20μg、20μg、20μg、20μg and 20μg respectively, totaling 270μg of antigens. Receives: Biological: Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) |
| The Group of Active Control Vaccine | Active comparator | Each 0.5-mL single-dose vial of GARDASIL9 contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein, totaling 270 mcg of antigens. Receives: Biological: Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse reaction(s) within 7 days post any dose of the interventions.
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reaction(s) within 7 days post any dose of the interventions.
Measured: 0-7 months
Secondary outcomes (20)
Percentage of adverse event(s) within 30 days post any dose of the interventions
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse event(s) within 30 days post any dose of the interventions
Measured: The 3rd day after each injection
Percentage of abnormal blood routine indexes, coagulation time and blood biochemical indexes
Percentage of subjects with abnormal blood routine indexes (concentrations of hemoglobin, white blood cells count), abnormal coagulation time (PT, APTT), and abnormal blood biochemical indexes (creatinine, alanine aminotransferase, aspartate aminotransferase) 3 days after any any dose of the interventions.
Measured: The 3rd and 7th month after immunization
Percentage of serious adverse event(s)
Percentage of subjects with serious adverse event(s) for the duration of the study (about 7 months).
Measured: 0-7 months
Levels of neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)
Levels of neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58) one month post dose 3 (Month 7) among trial subjects.
Measured: The 7th month after immunization
Percentage of subjects positive for neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)
Percentage of subjects positive for neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58) one month post dose 3 (Month 7) among trial subjects.
Measured: The 7th month after immunization
Levels of IgG antibodies
Levels of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) one month post dose 3 (Month 7) among trial subjects.
Measured: The 7th month after immunization
Seropositive rates of IgG antibodies
Seropositive rates of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) one month post dose 3 (Month 7) among trial subjects.
Measured: The 7th month after immunization
Levels of neutralizing antibodies
Levels of neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at month 3 post dose 1 among trial subjects.
Measured: The 3rd month after immunization
Levels of IgG antibodies
Levels of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at month 3 post dose 1 among trial subjects.
Measured: The 3rd month after immunization
Seropositive rates of neutralizing antibodies
Seropositive rates of neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at month 3 post dose 1 among trial subjects.
Measured: The 3rd month after immunization
Seropositive rates of IgG antibodies
Seropositive rates of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at month 3 post dose 1 among trial subjects.
Measured: The 3rd month after immunization
Seroconversion rates of neutralizing antibodies
Seroconversion rates of neutralizing antibodies Seroconversion rates of neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects.
Measured: The 3rd and 7th month after immunization
Seroconversion rates of IgG antibodies
Seroconversion rates of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects.
Measured: The 3rd and 7th month after immunization
Fold increases in levels of neutralizing antibodies and IgG antibodies
Fold increases in levels of neutralizing antibodies and IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects.
Measured: The 3rd and 7th month after immunization
Levels of neutralizing antibodies
Levels of neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Levels of IgG antibodies
Levels of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Seroconversion rates of neutralizing antibodies
Seroconversion rates of neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Seroconversion rates of IgG antibodies
Seroconversion rates of IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Fold increases in neutralizing antibodies
Fold increases in neutralizing antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Fold increases in IgG antibodies
Fold increases in IgG antibodies to each vaccine HPV type (6/11/16/18/31/33/45/52/58) at Month 3 and Month 7 post dose 1, respectively, among trial subjects who were negative for antibodies to the corresponding HPV type (HPV 6/11/16/18/31/33/45/52/58) prior to dose 1
Measured: Before immunization, and the 3rd and 7th month after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Sep 2019
- Primary completion6 Apr 2020
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies 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
- Model description
- The trial will be conducted in two stages: Stage 1: An open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form respectively. Stage 2: A randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Health Guard Biotechnology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Nanjing Sangruisi Pharmaceutical Technology Co., Ltd, School of Public Health of Southeastern University
- Responsible party
- Sponsor
- Investigators
- Yongjiang Liu, Bachelor, Study chair, Beijing Health Guard Biotechnology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680454
- Sponsor's protocol ID
- KLWS-V502-01
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No informed consent was obtained to disclose the subject's data and sample test results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial in Healthy Chinese Women Ages 18-45 to Evaluate the Safety and Tolerability Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)
- ClinicalTrials.gov ID
- NCT05680454
- Acronym / sponsor ID
- KLWS-V502-01
- Conditions
- Human Papillomavirus Infection
- Keywords
- CIN, VIN, VaIN, AIN, Cervical cancer, Vaginal cancer, vulvar cancer, Anal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Beijing Health Guard Biotechnology, IncIndustry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Nanjing Sangruisi Pharmaceutical Technology Co., Ltd, School of Public Health of Southeastern University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 11 Jan 2023 (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 study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45
Detailed description
This is a single-centre, dose-escalating, randomized, blinded and active controlled trial in healthy Chinese women ages 18-45. The positive control is Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine.
The trial will be conducted in two stages:
Stage 1: A single-center, open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form, respectively, to preliminarily evaluate the safety profile of the investigational vaccine.
First, the 20 subjects in the mid-dosage group will be sequentially enrolled as two batches of 5 and 15 subjects, respectively, at an enrolment interval of no less than 3 days. One week after vaccinating all the 20 subjects in the mid-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 20 subjects for the higher dosage-group will be enrolled subsequently in the same manner as those in the mid-dosage group.
Subjects in each dosage group will receive a 3-dose regimen at months 0, 2 and 6. Safety of the investigational vaccine will be assessed for 30 days following each injection, and SAE will be reported for the duration of the study. In total there will be 12 scheduled visits for subjects in each dosage group throughout the study.
One week after vaccinating all the 40 subjects in stage 1, if the safety profile of the investigational vaccine is confirmed to be acceptable, the study may proceed to stage 2.
Stage 2:
A phase I, single-center, dose-escalating, randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively (that is, 10 of the subjects in each dosage group will receive the positive control).
Firstly, the 40 subjects in the low-dosage group will be sequentially enrolled as four batches of 5, 10, 10 and 15 subjects, respectively, at an enrolment interval of no less than 3 days to get the first dose of the low-dosage investigational vaccine or positive control. Then, one week after vaccinating all the 40 subjects in the low-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 40 subjects will be enrolled subsequently into the mid-dosage group in the same manner as those in the low-dosage group. Again, one week after vaccinating the 40 subjects in the mid-dosage group, if the safety profile of the investigational vaccine continues to be acceptable, another group of 40 subjects receiving the high-dosage investigational vaccine or positive control will be enrolled subsequently in the same manner as those in the low-dosage group.
In both stage 1 and stage 2 of the phase I study, 5 ml of non-anticoagulative blood will be collected from trial subjects prior to dose 1 and at Month 3 and Month 7 post dose 1 to determine the levels of neutralizing antibodies and IgG antibodies to the vaccine HPV types.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The trial will be conducted in two stages: Stage 1: An open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form respectively. Stage 2: A randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively.
| Arm | Type | Receives |
|---|---|---|
| The Group of Investigational Vaccine | Experimental | Biological: Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)For Low-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 20μg、40μg、40μg、20μg、20μg、20μg、20μg、20μg, and 20μg respectively, totaling 220μg of antigens. For High-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg、40μg、80μg、60μg、30μg、30μg、30μg、30μg and 30μg respectively, totaling 360μg of antigens. For Mid-dosage group, 0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30μg、40μg、60μg、40μg、20μg、20μg、20μg、20μg and 20μg respectively, totaling 270μg of antigens. |
| The Group of Active Control Vaccine | Active comparator | Biological: Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) VaccineEach 0.5-mL single-dose vial of GARDASIL9 contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein, totaling 270 mcg of antigens. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female subjects 27-45 years of age (inclusive of 27 and 45 years of age);
- Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
- Subjects who understand and agree to comply with the study procedures and provide written informed consent;
- Subjects who are able to comply with protocol-specified requirements;
- Subjects with negative urine pregnancy test result at screening;
Key exclusion criteria (23 listed)
- The same exclusion criteria apply to both stage 1 and stage 2
- Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
- Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
- Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
- Women who have known allergy history or who are allergic to any component of the interventions, such as penicillin and amikacin;
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 |
|---|---|---|
| Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)For Low-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6. | Biological | The Group of Investigational Vaccine |
| Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) VaccineA 3-dose regimen administered at months 0, 2 and 6. | Biological | The Group of Active Control Vaccine |
Primary outcome
Percentage of adverse reaction(s) within 7 days post any dose of the interventions.
Time frame: 0-7 months
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reaction(s) within 7 days post any dose of the interventions.
20 secondary outcomes
Percentage of adverse event(s) within 30 days post any dose of the interventions
Time frame: The 3rd day after each injection
Percentage of abnormal blood routine indexes, coagulation time and blood biochemical indexes
Time frame: The 3rd and 7th month after immunization
Percentage of serious adverse event(s)
Time frame: 0-7 months
Levels of neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)
Time frame: The 7th month after immunization
Percentage of subjects positive for neutralization antibodies against each vaccine HPV type (6/11/16/18/31/33/45/52/58)
Time frame: The 7th month after immunization
Levels of IgG antibodies
Time frame: The 7th month after immunization
Seropositive rates of IgG antibodies
Time frame: The 7th month after immunization
Levels of neutralizing antibodies
Time frame: The 3rd month after immunization
Levels of IgG antibodies
Time frame: The 3rd month after immunization
Seropositive rates of neutralizing antibodies
Time frame: The 3rd month after immunization
Seropositive rates of IgG antibodies
Time frame: The 3rd month after immunization
Seroconversion rates of neutralizing antibodies
Time frame: The 3rd and 7th month after immunization
Seroconversion rates of IgG antibodies
Time frame: The 3rd and 7th month after immunization
Fold increases in levels of neutralizing antibodies and IgG antibodies
Time frame: The 3rd and 7th month after immunization
Levels of neutralizing antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
Levels of IgG antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
Seroconversion rates of neutralizing antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
Seroconversion rates of IgG antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
Fold increases in neutralizing antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
Fold increases in IgG antibodies
Time frame: Before immunization, and the 3rd and 7th month after immunization
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 17 Jan 2023.
- Individual participant dataSharing planned: No. No informed consent was obtained to disclose the subject's data and sample test results.
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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.
Yongjiang Liu, Bachelor study chair
Beijing Health Guard Biotechnology, Inc
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 Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) and Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine in people with Human Papillomavirus Infection, run by Beijing Health Guard Biotechnology, Inc 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 16 inclusion and 23 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 17 Jan 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. 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 adverse reaction(s) within 7 days post any dose of the interventions. (time frame: 0-7 months). 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 17 Jan 2023.