Human Papilloma Virus InfectionPhase 2NCT05694728

A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine

A Phase 2 study testing Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) and Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae) in people with Human Papilloma Virus Infection, run by Beijing Health Guard Biotechnology, Inc at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Papilloma Virus 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 Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 780 participants
Where: 1 siteChina
Study dates: 23 May 2020to 27 Jan 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female subjects ages 20-45 (inclusive of 20 years of age 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 agree to participate in the trial after being fully informed of the study, and provide a written informed consent;
Trial subjects who are able to comply with protocol-specified requirements;
Trial subjects with negative urine pregnancy test at screening;
Trial subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or female 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 of the interventions and throughout the study.
Subjects with axillary temperature≤37.0℃.

Who cannot join

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 anaphylaxis history or 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;
Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;

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Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past 2 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 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 epilepsy other than epilepsy with febrile seizures under the age of two, 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);
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 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 such subject's ability to give informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

CDC, Jiangsu Province
Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Phase II Trial in Healthy Chinese Women Ages 20-45 to Evaluate the Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.

Read the detailed description

This is a single-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV vaccine GARDASIL®) Phase II clinical trial.

The trial will recruit a total of approximately 780 Chinese women 20-45 years of age with permanent residence. Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control (quadrivalent HPV vaccine GARDASIL®), respectively.

Each subject will be administered 0.5 ml of the investigational vaccine or control in accordance with a 3-dose regimen at months 0, 2 and 6.

Peripheral blood samples of each subject will be collected at Day 0 (prior to dose 1), Month 7 (1 month post dose 3) to determine the levels of neutralizing antibodies and IgG antibodies to HPV types 6/11/16/18/31/33/45/52/58 in the sera. Optimal ratio of the antigens included in the investigational vaccine will be decided based on the immunogenicity and safety data from this trail.

Conditions: Human Papilloma Virus Infection
Being tested: Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli), Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)
Keywords: CIN, VIN, VaIN, AIN, Cervical cancer, Vulvar cancer, Anal cancer, Genital warts
Medical subject headings: Papillomavirus Infections, Uterine Cervical 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 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 Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)Biological
A 3-dose regimen administered at months 0, 2 and 6.

Study groups in NCT05694728
Study group	Role	What they receive
The Group of Investigational Vaccine	Experimental	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. 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. 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	0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens. Receives: Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of adverse reactions up to Day 7 after each dose of the interventions
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reactions up to Day 7 after each dose of the interventions
Measured: 0-7 days after each immunization
To determine the optimal ratio of antigens included in the investigational vaccine
To determine the optimal ratio of antigens included in the investigational vaccine through non-inferiority analysis of the GMTs of neutralizing antibodies specific to vaccine HPV types 6, 11, 16 and 18 elicited by the investigational vaccine versus those induced by the positive control, in subjects negative for antibodies to such vaccine HPV types prior to dose 1.
Measured: The 1st month after full immunization

Secondary outcomes (11)

Percentage of adverse events up to Day 30 after each dose of the interventions
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse events up to Day 30 after each dose of the interventions
Measured: 0-30 days after each immunization
Percentage of erious adverse events for the duration of the study
Percentage of subjects with serious adverse events for the duration of the study (from Day 1 till Month 7)
Measured: Through study completion, an average of 7 months
To demonstrate that the levels of neutralizing antibodies
To demonstrate that the levels of neutralizing antibodies specific to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil through assessing the GMTs of neutralizing antibodies to HPV types 31, 33, 45, 52 and 58 in the sera of the subjects who are negative for antibodies to such HPV types prior to dose 1 of the investigational vaccine in comparison with those administered Gardasil.
Measured: The 1st month after full immunization
To evaluate the levels of neutralizing antibodies
Subgroup Analysis: To evaluate the levels of neutralizing antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among 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: The 7th month after first immunization
To evaluate the levels of IgG antibodies
Subgroup Analysis: To evaluate the levels of IgG antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among 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: The 7th month after first immunization
To evaluate the rates of seropositivity
Subgroup Analysis: To evaluate the rates of seropositivity to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among 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: The 7th month after first immunization
To evaluate the rates of seroconversion
Subgroup Analysis: To evaluate the rates of seroconversion to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among 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: The 7th month after first immunization
To evaluate the levels of neutralizing antibodies among all subjects
To evaluate the levels of neutralizing antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.
Measured: The 7th month after first immunization
To evaluate the levels of IgG antibodies among all subjects
To evaluate the levels of IgG antibodies to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.
Measured: The 7th month after first immunization
To evaluate the rates of seropositivity among all subjects
To evaluate the rates of seropositivity to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.
Measured: The 7th month after first immunization
To evaluate the rates of seroconversion among all subjects
To evaluate the rates of seroconversion to each HPV type (HPV 6/11/16/18/31/33/45/52/58) at Month 7 post dose 1 among all subjects.
Measured: The 7th month after first immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202027 Jan 2021

First posted23 Jan 2023
Study start23 May 2020
Primary completion11 Dec 2020
Study completion27 Jan 2021

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 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control, respectively.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 780 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05694728
Sponsor's protocol ID: KLWS-V502-02
Status last verified: Dec 2022
First submitted: 12 Dec 2022
Last updated: 23 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

Publications

Wei M, Liu H, Yu H, Pan H, Tao H, Zhang J, Han W, Wu D, Wang W, Li J. Immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial. Front Immunol. 2025 Nov 14;16:1706662. doi: 10.3389/fimmu.2025.1706662. eCollection 2025.
PubMed 41322412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Human Papilloma Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial in Healthy Chinese Women Ages 20-45 to Evaluate the Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)
ClinicalTrials.gov ID: NCT05694728
Acronym / sponsor ID: KLWS-V502-02
Conditions: Human Papilloma Virus Infection
Keywords: CIN, VIN, VaIN, AIN, Cervical cancer, Vulvar cancer, Anal cancer, Genital warts
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 780 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 pharmtech Ltd., Shanghai Canming pharmtech Ltd.
Study start: 23 May 2020 (actual)
Primary completion: 11 Dec 2020 (actual)
Study completion: 27 Jan 2021 (actual)
First posted: 23 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.

Detailed description

This is a single-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV vaccine GARDASIL®) Phase II clinical trial.

Each subject will be administered 0.5 ml of the investigational vaccine or control in accordance with a 3-dose regimen at months 0, 2 and 6.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the 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 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. 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.
The Group of Active Control Vaccine	Active comparator	Biological: Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens.

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Female subjects ages 20-45 (inclusive of 20 years of age 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 agree to participate in the trial after being fully informed of the study, and provide a written informed consent;
Trial subjects who are able to comply with protocol-specified requirements;
Trial subjects with negative urine pregnancy test at screening;

Key exclusion criteria (23 listed)

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 anaphylaxis history or 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;

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 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 Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)A 3-dose regimen administered at months 0, 2 and 6.	Biological	The Group of Active Control Vaccine

Primary outcome

Percentage of adverse reactions up to Day 7 after each dose of the interventions
Time frame: 0-7 days after each immunization
Percentage of subjects with 1 or more injection-site or non-injection-site (systemic) adverse reactions up to Day 7 after each dose of the interventions
To determine the optimal ratio of antigens included in the investigational vaccine
Time frame: The 1st month after full immunization
To determine the optimal ratio of antigens included in the investigational vaccine through non-inferiority analysis of the GMTs of neutralizing antibodies specific to vaccine HPV types 6, 11, 16 and 18 elicited by the investigational vaccine versus those induced by the positive control, in subjects negative for antibodies to such vaccine HPV types prior to dose 1.

11 secondary outcomes

Percentage of adverse events up to Day 30 after each dose of the interventions
Time frame: 0-30 days after each immunization
Percentage of erious adverse events for the duration of the study
Time frame: Through study completion, an average of 7 months
To demonstrate that the levels of neutralizing antibodies
Time frame: The 1st month after full immunization
To evaluate the levels of neutralizing antibodies
Time frame: The 7th month after first immunization
To evaluate the levels of IgG antibodies
Time frame: The 7th month after first immunization
To evaluate the rates of seropositivity
Time frame: The 7th month after first immunization
To evaluate the rates of seroconversion
Time frame: The 7th month after first immunization
To evaluate the levels of neutralizing antibodies among all subjects
Time frame: The 7th month after first immunization
To evaluate the levels of IgG antibodies among all subjects
Time frame: The 7th month after first immunization
To evaluate the rates of seropositivity among all subjects
Time frame: The 7th month after first immunization
To evaluate the rates of seroconversion among all subjects
Time frame: The 7th month after first 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 23 Jan 2023.
Derived from this study: PubMed 41322412Wei M, Liu H, Yu H, Pan H, Tao H, Zhang J, Han W, Wu D, Wang W, Li J. Immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus vaccine (types 6/11/16/18/31/33/45/52/58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial. Front Immunol. 2025 Nov 14;16:1706662. doi: 10.3389/fimmu.2025.1706662. eCollection 2025.
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?

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 7 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 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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 reactions up to Day 7 after each dose of the interventions (time frame: 0-7 days after each immunization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694728, 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 23 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.