SARS-CoV-2Phase 3NCT05682638
A Global Multi-center Clinical Study of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19
A Phase 3 study testing LVRNA009 and 0.9%NaCl in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in Kenya.
Trial summary
A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- LVRNA009 and 0.9%NaCl
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34,000 participants
- Where
- 1 siteKenya
- Study dates
- 30 Jan 2023to Dec 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Understand the content of the Informed Consent Form (ICF), and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed).
- Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- Female participants of childbearing potential or partners of male participants:
- voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after full vaccination (including the initial set of vaccination and crossover set of vaccination). [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.].
- For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before each vaccination in this study.
- On the day of 1st dose of vaccination and 24 hours prior to vaccination, axillary temperatures <37.3°C/99.1°F.
- Healthy participants or participants with mild underlying disease [in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study].
Who cannot join
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.
- Individuals using prescription medications for prophylaxis or treatment of SARS-CoV-2 (including vaccination of licensed COVID-19 vaccines).
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- History of allergy to any component of the study vaccine or history of severe allergic reaction to vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
- Positive HIV test results.
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- A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
- Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.
- Asplenia or functional asplenia, complete or partial splenectomy from any cause.
- Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the 1st dose of investigational vaccine.
- Any other licensed vaccines given within 28 days prior to the study vaccination, or planned administration of vaccine(s) within 28 days after the 2nd dose in the blinded crossover vaccination.
- Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
- Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period.
- Participants who have received any other investigational product within 1 month prior to enrollment or intent to participate in another clinical study at any time during the conduct of this study.
- Women who are pregnant or breastfeeding.
- Participants deemed unsuitable for participation in this study based on the investigator's assessment.
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
KEMRI CRDR Research Annex, Siaya Country Referral Hospital
Siaya, 144-40600
Videlis Nduba, PHD, 254-724-52247, vnduba@gmail.com
About this study
Official title: A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older
A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
- Conditions
- SARS-CoV-2
- Being tested
- LVRNA009, 0.9%NaCl
- Keywords
- mRNA, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVRNA009Biological
100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart
0.9%NaClOther
1.0ml/dose, 2 injection with 28 days apart
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group | Experimental | Phase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo Receives: Biological: LVRNA009; Other: 0.9%NaCl |
| Control group | Placebo comparator | Phase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009 Receives: Biological: LVRNA009; Other: 0.9%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring in SARS-CoV-2 naive participants in vaccine(100μg) group
Measured: From 14 days after the 2nd dose in the initial set of vaccination
Secondary outcomes (25)
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 naive participants
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death for SARS-CoV-2 naive participants
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 naive participants at different age strata (18-59 years, ≥60 years)
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 non-naive participants
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 non-naive participants
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring regardless prior SARS-CoV-2 infection
Measured: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Measured: From the 1st dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Measured: From 7 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 native participants
Measured: From 14 days after the 2nd dose in the crossover set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Measured: From 14 days after the 2nd dose in the crossover set of vaccination
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death regardless prior SARS-CoV-2 infection
Measured: From 14 days after the 2nd dose in the crossover set of vaccination
Incidence, severity and duration of each solicited (local and systemic) Adverse Event (AE)
Measured: Within 14 days post each dose in reactogenicity subgroup in the initial set of vaccination
Incidence, severity, and causality of AEs occurring
Measured: 0-28 days post each dose
Incidence, severity, and causality of Serious Adverse Events (SAEs)
Measured: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Incidence, severity, and causality of Adverse Events of Special Interest (AESIs)
Measured: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Incidence, severity, and causality of pregnancy events
Measured: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Measured: 14 days, 28 days, 3 months and 6 months after the 2nd dose
Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Measured: 28 days, 3 months, 6 months and 12 months after the 2nd dose
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Measured: 14 days, 28 days, 3 months and 6 months after the 2nd dose
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Measured: 28 days, 3 months, 6 months and 12 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Measured: 14 days, 28 days, 3 months and 6 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline in the crossover set of vaccination
Measured: 28 days, 3 months, 6 months and 12 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Measured: 14 days, 28 days, 3 months and 6 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline in the crossover set of vaccination
Measured: 28 days, 3 months, 6 months and 12 months after the 2nd dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start30 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIM Vaccine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIM Innovation Biotechnology (Shanghai) Co., Ltd, Ningbo Rongan Biological Pharmaceutical Co., Ltd., LiveRNA Therapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682638
- Sponsor's protocol ID
- LVRNA009-II/III-01
- Status last verified
- Aug 2022
- First submitted
- 8 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05682638
- Acronym / sponsor ID
- LVRNA009-II/III-01
- Conditions
- SARS-CoV-2
- Keywords
- mRNA, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34,000 participants (estimated)
- Lead sponsor
- AIM Vaccine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- AIM Innovation Biotechnology (Shanghai) Co., Ltd, Ningbo Rongan Biological Pharmaceutical Co., Ltd., LiveRNA Therapeutics Inc.
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 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.
A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Older
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine group | Experimental | Biological: LVRNA009, Other: 0.9%NaClPhase 3(Base the result of Phase 1 and Phase 2, intervent 100μg): initial vaccination stage- LVRNA009; crossover vaccination stage- placebo |
| Control group | Placebo comparator | Biological: LVRNA009, Other: 0.9%NaClPhase 3: initial vaccination stage- placebo; crossover vaccination stage- LVRNA009 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years and older.
- Understand the content of the Informed Consent Form (ICF), and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed).
- Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- Female participants of childbearing potential or partners of male participants:
- voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after full vaccination (including the initial set of vaccination and crossover set of vaccination). [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.].
Key exclusion criteria (16 listed)
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.
- Individuals using prescription medications for prophylaxis or treatment of SARS-CoV-2 (including vaccination of licensed COVID-19 vaccines).
- History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
- History of allergy to any component of the study vaccine or history of severe allergic reaction to vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
- Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
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 |
|---|---|---|
| LVRNA009100μg/1.0ml/dose(50 μg/0.5ml/Vial), 2 injection with 28 days apart | Biological | Control group, Vaccine group |
| 0.9%NaCl1.0ml/dose, 2 injection with 28 days apart | Other | Control group, Vaccine group |
Primary outcome
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring in SARS-CoV-2 naive participants in vaccine(100μg) group
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
25 secondary outcomes
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 naive participants
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death for SARS-CoV-2 naive participants
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 naive participants at different age strata (18-59 years, ≥60 years)
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring for SARS-CoV-2 non-naive participants
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 non-naive participants
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring regardless prior SARS-CoV-2 infection
Time frame: From 14 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Time frame: From the 1st dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring
Time frame: From 7 days after the 2nd dose in the initial set of vaccination
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 for SARS-CoV-2 native participants
Time frame: From 14 days after the 2nd dose in the crossover set of vaccination
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 for SARS-CoV-2 naive participants
Time frame: From 14 days after the 2nd dose in the crossover set of vaccination
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death regardless prior SARS-CoV-2 infection
Time frame: From 14 days after the 2nd dose in the crossover set of vaccination
Incidence, severity and duration of each solicited (local and systemic) Adverse Event (AE)
Time frame: Within 14 days post each dose in reactogenicity subgroup in the initial set of vaccination
Incidence, severity, and causality of AEs occurring
Time frame: 0-28 days post each dose
Incidence, severity, and causality of Serious Adverse Events (SAEs)
Time frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Incidence, severity, and causality of Adverse Events of Special Interest (AESIs)
Time frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Incidence, severity, and causality of pregnancy events
Time frame: From the day of 1st dose in the initial set of vaccination to 12 months after the 2nd dose in crossover set of vaccination
Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
Geometric mean Titer (GMT) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Time frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
Geometric mean Increase (GMI) of SARS-CoV-2 virus neutralizing antibody responses and S-protein IgG antibody responses in the crossover set of vaccination
Time frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seronegative participants at baseline in the crossover set of vaccination
Time frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline of the initial set of vaccination or the day of crossover vaccination (whichever comes earlier)
Time frame: 14 days, 28 days, 3 months and 6 months after the 2nd dose
The seroconversion rate (SCR) of SARS-CoV-2 virus neutralizing antibody and S-protein IgG antibodies in seropositive participants at baseline in the crossover set of vaccination
Time frame: 28 days, 3 months, 6 months and 12 months after the 2nd dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LVRNA009 and 0.9%NaCl in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd. at 1 site in Kenya.
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 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 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 Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Videlis Nduba, PHD (254-724-52247, vnduba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring in SARS-CoV-2 naive participants in vaccine(100μg) group (time frame: From 14 days after the 2nd dose in the initial set of vaccination). 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 21 Feb 2023.