Herpes ZosterPhase 1/2NCT06851832
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
A Phase 1/2 study testing Recombinant zoster vaccine(CHO cell)(low adjuvant), Recombinant Zoster Vaccine (CHO cell) and Zoster Vaccine, Live in people with Herpes Zoster and Herpes Zoster Vaccine, run by Ab&B Bio-tech Co., Ltd.JS at 1 site in China.
Trial summary
The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Herpes Zoster Vaccine
- What is being tested?
- Recombinant zoster vaccine(CHO cell)(low adjuvant), Recombinant Zoster Vaccine (CHO cell) and Zoster Vaccine, Live
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 960 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2025to 16 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged 40 years or older at the time of enrollment.
- Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form.
- Able to attend all scheduled follow-ups and comply with the clinical trial protocol requirements to complete the trial.
- Female participants must meet the following criteria:1)Surgically sterilized or postmenopausal for ≥2 years, or women of childbearing potential (not menopausal or menopausal <2 years) with a negative pregnancy test and willing to use effective physical contraception (e.g., condoms, intrauterine device) from enrollment until 6 months after full immunization. 2)Agree not to breastfeed from enrollment until 6 months after full immunization.
- Axillary temperature ≤37.0°C.
Who cannot join
- a Exclusion criteria for the first dose:
- A history of herpes zoster.
- A history of varicella or herpes zoster vaccination.
- Close contact with a varicella/herpes zoster patient within the past year.
- Received immunoglobulin and/or any blood products within 3 months before vaccination.
- Received immunosuppressive treatment within 3 months prior to vaccination (e.g., systemic corticosteroids for ≥14 days, at a dose ≥2 mg/kg/day or ≥20 mg/day of prednisone, or an equivalent dose of prednisone) (excluding inhaled, intra-articular, and topical steroids).
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- A history of severe allergic reactions to any vaccine or medication (e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reactions, severe urticaria, etc.), or a family history of severe allergies.
- Immunocompromised or diagnosed with congenital or acquired immune deficiency diseases, or infected with Human Immunodeficiency Virus (HIV).
- A history of seizures, epilepsy, encephalopathy (such as congenital brain malformation, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction [except for infarction without sequelae or lacunar infarction], brain infections, or brain damage caused by chemical drug poisoning), or psychiatric disorders, or a family history of psychiatric disorders; or other serious neurological diseases.
- Inadequate time interval between vaccination and other vaccines (e.g., inactivated or recombinant subunit vaccines within 14 days prior to vaccination, live attenuated vaccines, viral vector vaccines, or mRNA vaccines within 28 days prior to vaccination).
- Acute illness or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or antihistamine medications within 3 days prior to vaccination.
- Suffering from severe infectious skin diseases.
- Ongoing or long-term alcohol and/or drug abuse history (Note: for the past three months, males drinking more than 14 standard drinks per week, females more than 7 standard drinks per week. One standard drink contains 14g of alcohol, equivalent to 360mL of beer, 45mL of liquor at 40% alcohol, or 150mL of wine. Drug abuse refers to the repeated or excessive use of drugs with dependence potential unrelated to recognized medical needs, for non-medical purposes).
- A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection.
- Severe liver or kidney disease, complications from diabetes, severe cardiovascular diseases, or uncontrolled hypertension despite medication.
- Asplenia or functional asplenia, or any condition leading to splenectomy.
- Abnormal laboratory test results before the first dose, deemed clinically significant by the investigator (only applicable to Phase I).
- Currently participating in other experimental or unregistered clinical trials for products (drugs, vaccines, or devices), or planning to participate in another clinical trial before the end of this trial.
- A history of hematologic or lymphatic system diseases, such as unexplained lymphadenopathy or hematolymphatic lymphoma.
- A history of diagnosed potential immune-mediated diseases, autoimmune diseases, or Guillain-Barré syndrome.
- Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial.
- a Exclusion criteria for the second dose:
- Positive urine pregnancy test.
- Grade 4 adverse events related to vaccination.
- Severe allergic reactions occurring after vaccination.
- New findings or newly occurring conditions that meet the exclusion criteria after the first dose, with the investigator determining whether to terminate the trial vaccine administration.
- Other situations assessed by the investigator as requiring termination of vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan
About this study
Official title: A Phase I/II Clinical Trial With Randomized, Blinded, Controlled Design to Evaluate the Safety and Immunogenicity of the Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Populations Aged 40 Years and Older Post -Vaccination
The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.
- Conditions
- Herpes Zoster, Herpes Zoster Vaccine
- Being tested
- Recombinant zoster vaccine(CHO cell)(low adjuvant), Recombinant Zoster Vaccine (CHO cell), Zoster Vaccine, Live, Recombinant Zoster Vaccine (CHO cell) (Adjuvant control), Normal Saline
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant zoster vaccine(CHO cell)(low adjuvant)Biological
The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 50 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.
Recombinant Zoster Vaccine (CHO cell)Biological
The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle.
Vaccination Schedule 1: A total of two doses will be given, with the second dose administered 30 days after the first dose.
Vaccination Schedule 2: A total of two doses will be given, with the second dose administered 60 days after the first dose [only applicable to the Phase II Experimental Vaccine Group B2].
Zoster Vaccine, LiveBiological
The dosage for each administration is 0.5 mL, containing not less than 4.3 lg PFU of varicella-zoster live virus, administered subcutaneously at the attachment site of the lower edge of the deltoid muscle on the outer side of the upper arm.
A total of one dose will be given. To maintain blinding, the positive control group A1 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 30. The positive control group A2 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 60.
Recombinant Zoster Vaccine (CHO cell)Biological
The dosage for each administration is 0.5 mL, containing 50 μg of gE and the AS01B adjuvant system [QS-21 (50 μg), MPL (50 μg), DOPC (1 mg), and cholesterol (0.25 mg)], administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 60 days after the first dose.
Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)Biological
The dosage for each administration is 0.5 mL, containing 0.25 mL of MF59 and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.
Normal SalineBiological
The dosage for each administration is 0.5 mL, containing 0.5 mL of NaCl solution, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose (applicable to Phase I clinical trial).
To maintain blinding, subjects in the positive control A1 and positive control A2 groups will receive a placebo on Day 0 (applicable to Phase II clinical trial).
| Study group | Role | What they receive |
|---|---|---|
| Recombinant zoster Vaccine (CHO cell) (low adjuvant) | Experimental | It is used for vaccination of experimental vaccine group A subjects in phase I and II clinical trials Receives: Biological: Recombinant zoster vaccine(CHO cell)(low adjuvant) |
| Recombinant zoster Vaccine (CHO cell) | Experimental | It is used for vaccination of experimental vaccine group B subjects of phase I clinical trial , experimental vaccine group B1 and B2 subjects of phase II clinical trial |
| Zoster Vaccine, Live | Active comparator | It is used for vaccination of positive control group A1 and A2 subjects in phase Ⅱ clinical trial Receives: Biological: Zoster Vaccine, Live |
| Recombinant Zoster Vaccine (CHO cell) | Active comparator | It is used for vaccination of positive control group B subjects in phase Ⅱ clinical trial |
| Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) | Placebo comparator | It is used for vaccination of adjuvant control group subjects in phase Ⅰ clinical trial Receives: Biological: Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) |
| normal saline | Placebo comparator | Used in phase Ⅰ clinical trial; To maintain blinding, positive control group A1 and positive control group A2 received placebo on day 0 (for phase II clinical trial). Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.
Measured: Within 14 days after each vaccine dose.
The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.
Measured: Within 30 days after each vaccine dose.
The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose.
Measured: On Day 3 after each vaccine dose.（Applicable to Phase I only）
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization.
Measured: From the vaccination of the first dose to 12 months after full immunization.
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization.
Detected using intracellular cytokine staining (ICS) by flow cytometry
Measured: One month after full immunization.（Applicable to Phase Ⅱ only）
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.
Detected using enzyme-linked immunosorbent assay (ELISA).
Measured: One month after full immunization.（Applicable to Phase Ⅱ only）
Secondary outcomes (2)
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies at 6, 12, 24, and 36 months after full immunization.
Detected using enzyme-linked immunosorbent assay (ELISA)
Measured: At 6, 12, 24, and 36 months after full immunization.（Applicable to Phase Ⅱ only）
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) before the second dose and at 6, 12, 24, and 36 months after full immunization.
Detected using intracellular cytokine staining (ICS) by flow cytometry
Measured: Before the second dose and at 6, 12, 24, and 36 months after full immunization（Applicable to Phase Ⅱ only）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start16 Feb 2025
- Primary completion28 Oct 2026 (estimated)
- Study completion16 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JS
- Sponsor type
- University, hospital or other
- Collaborators
- Yither Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Zhiqiang Xie, Master, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851832
- Sponsor's protocol ID
- VZV-ZHSW-01
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial With Randomized, Blinded, Controlled Design to Evaluate the Safety and Immunogenicity of the Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Populations Aged 40 Years and Older Post -Vaccination
- ClinicalTrials.gov ID
- NCT06851832
- Acronym / sponsor ID
- VZV-ZHSW-01
- Conditions
- Herpes Zoster, Herpes Zoster Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- Ab&B Bio-tech Co., Ltd.JSUniversity, hospital or other
- Collaborators
- Yither Biotechnology Co., Ltd
- Study start
- 16 Feb 2025 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 16 Sep 2028 (estimated)
- First posted
- 28 Feb 2025 (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 objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Recombinant zoster Vaccine (CHO cell) (low adjuvant) | Experimental | Biological: Recombinant zoster vaccine(CHO cell)(low adjuvant)It is used for vaccination of experimental vaccine group A subjects in phase I and II clinical trials |
| Recombinant zoster Vaccine (CHO cell) | Experimental | –It is used for vaccination of experimental vaccine group B subjects of phase I clinical trial , experimental vaccine group B1 and B2 subjects of phase II clinical trial |
| Zoster Vaccine, Live | Active comparator | Biological: Zoster Vaccine, LiveIt is used for vaccination of positive control group A1 and A2 subjects in phase Ⅱ clinical trial |
| Recombinant Zoster Vaccine (CHO cell) | Active comparator | –It is used for vaccination of positive control group B subjects in phase Ⅱ clinical trial |
| Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) | Placebo comparator | Biological: Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)It is used for vaccination of adjuvant control group subjects in phase Ⅰ clinical trial |
| normal saline | Placebo comparator | Biological: Normal SalineUsed in phase Ⅰ clinical trial; To maintain blinding, positive control group A1 and positive control group A2 received placebo on day 0 (for phase II clinical trial). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 40 years or older at the time of enrollment.
- Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form.
- Able to attend all scheduled follow-ups and comply with the clinical trial protocol requirements to complete the trial.
- Female participants must meet the following criteria:1)Surgically sterilized or postmenopausal for ≥2 years, or women of childbearing potential (not menopausal or menopausal <2 years) with a negative pregnancy test and willing to use effective physical contraception (e.g., condoms, intrauterine device) from enrollment until 6 months after full immunization. 2)Agree not to breastfeed from enrollment until 6 months after full immunization.
- Axillary temperature ≤37.0°C.
Key exclusion criteria (27 listed)
- A history of herpes zoster.
- A history of varicella or herpes zoster vaccination.
- Close contact with a varicella/herpes zoster patient within the past year.
- Received immunoglobulin and/or any blood products within 3 months before vaccination.
- Received immunosuppressive treatment within 3 months prior to vaccination (e.g., systemic corticosteroids for ≥14 days, at a dose ≥2 mg/kg/day or ≥20 mg/day of prednisone, or an equivalent dose of prednisone) (excluding inhaled, intra-articular, and topical steroids).
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 zoster vaccine(CHO cell)(low adjuvant)The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 50 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose. | Biological | Recombinant zoster Vaccine (CHO cell) (low adjuvant) |
| Recombinant Zoster Vaccine (CHO cell)The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. Vaccination Schedule 1: A total of two doses will be given, with the second dose administered 30 days after the first dose. Vaccination Schedule 2: A total of two doses will be given, with the second dose administered 60 days after the first dose [only applicable to the Phase II Experimental Vaccine Group B2]. | Biological | – |
| Zoster Vaccine, LiveThe dosage for each administration is 0.5 mL, containing not less than 4.3 lg PFU of varicella-zoster live virus, administered subcutaneously at the attachment site of the lower edge of the deltoid muscle on the outer side of the upper arm. A total of one dose will be given. To maintain blinding, the positive control group A1 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 30. The positive control group A2 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 60. | Biological | Zoster Vaccine, Live |
| Recombinant Zoster Vaccine (CHO cell)The dosage for each administration is 0.5 mL, containing 50 μg of gE and the AS01B adjuvant system [QS-21 (50 μg), MPL (50 μg), DOPC (1 mg), and cholesterol (0.25 mg)], administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 60 days after the first dose. | Biological | – |
| Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)The dosage for each administration is 0.5 mL, containing 0.25 mL of MF59 and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose. | Biological | Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) |
| Normal SalineThe dosage for each administration is 0.5 mL, containing 0.5 mL of NaCl solution, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose (applicable to Phase I clinical trial). To maintain blinding, subjects in the positive control A1 and positive control A2 groups will receive a placebo on Day 0 (applicable to Phase II clinical trial). | Biological | normal saline |
Primary outcome
The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.
Time frame: Within 14 days after each vaccine dose.
The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.
Time frame: Within 30 days after each vaccine dose.
The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose.
Time frame: On Day 3 after each vaccine dose.（Applicable to Phase I only）
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization.
Time frame: From the vaccination of the first dose to 12 months after full immunization.
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization.
Time frame: One month after full immunization.（Applicable to Phase Ⅱ only）
Detected using intracellular cytokine staining (ICS) by flow cytometry
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.
Time frame: One month after full immunization.（Applicable to Phase Ⅱ only）
Detected using enzyme-linked immunosorbent assay (ELISA).
2 secondary outcomes
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies at 6, 12, 24, and 36 months after full immunization.
Time frame: At 6, 12, 24, and 36 months after full immunization.（Applicable to Phase Ⅱ only）
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) before the second dose and at 6, 12, 24, and 36 months after full immunization.
Time frame: Before the second dose and at 6, 12, 24, and 36 months after full immunization（Applicable to Phase Ⅱ only）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Zhiqiang Xie, Master principal investigator
Henan 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 1/2 study testing Recombinant zoster vaccine(CHO cell)(low adjuvant), Recombinant Zoster Vaccine (CHO cell) and Zoster Vaccine, Live in people with Herpes Zoster and Herpes Zoster Vaccine, run by Ab&B Bio-tech Co., Ltd.JS 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 5 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose. (time frame: Within 14 days after each vaccine dose.). The study lists 6 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 28 Oct 2026.