COVID-19Phase 2/3NCT05636319
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine
A Phase 2/3 study testing ABO1020 in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. at 25 sites in 4 countries.
Trial summary
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ABO1020
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14,168 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 23 Nov 2022to 31 Jul 2024
- Phase
- Phase 2/3
- 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
- Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study.
- Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF.
- Subjects who have previously been fully vaccinated either by 2 or 3 doses of SARS-CoV-2 inactivated vaccine. The last dose of immunization should be >6 months before administration of the investigational products.
- Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
- Males and females with childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after completing the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device [IUD], condoms [male], diaphragm, and cervical cap).
Who cannot join
- Positive SARS-CoV-2 rapid test at screening.
- Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS).
- Fever (axillary temperature or equivalent ≥ 37.3℃*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
- Abnormal vital signs (pulse < 60 bpm or > 100 bpm, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg when keeping awake) with clinical relevance.
- Do not remain overall healthy (i.e., has medically deteriorated significantly since receiving the two-dose vaccination, is anticipated to have fatal outcome of uncontrolled diseases within 12 months, and is not able to provide blood as specified by the trial with anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination.
- Pregnant or lactating women, or those who plan to donate sperm or egg during the trial.
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- Prior history of allergic reaction or anaphylaxis to any vaccine or its excipients, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.
- Prior use of any other vaccine within 28 days before using the investigational products or planning to use any vaccine other than the investigational products during the study period.
- Participation in the studies of any other interventional device or drug within 30 days before the screening, or current treatment with other investigational drug(s) or within 5 half-lives after taking the last dose of the study drug.
- Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of serious bleeding, or a history of massive bleeding after intramuscular injection or intravenous puncture or ecchymosis.
- Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus [HIV]), and uncontrolled autoimmune disease.
- Serious or uncontrolled respiratory system disorders, cardiovascular disorders, nervous system disorders, blood and lymphatic system disorders, liver and kidney disorders, metabolism and skeletal disorders,etc. influencing study results evaluation at the investigator's discretion.
- Asplenia or functional asplenia.
- Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs) within 6 months prior to administration of this investigational vaccine, except for topical medications (e.g., ointments, eye drops, inhalants or nasal sprays). And the topical medications should not exceed the recommended dose in the labels for use or induce any signs of systemic exposure.
- Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.
- Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject's compliance at the investigator's discretion.
- Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits.
- Receiving antituberculosis treatment.
- Staff of study site, sponsor and contract research organization (CRO) taking part in the study.
- Other conditions that the investigators consider unsuitable for this study.
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
Pakistan8 sites
Rehman Medical Institute
Basti Khyber
Central Hospital, Gujranwala
Gujranwala
Maroof International Hospital, Islamabad
Islamabad
Akram Medical Complex
Lahore
Avicenna Medical College
Lahore
Central Park Teaching Hospital
Lahore
National Hospital and Medical center
Lahore
Al-Shifa Trust Eye Hospital
Rawalpindi
Philippines8 sites
Manuel J. Santos Hospita
Butuan
Premiere Medical Center
Cabanatuan City
Silang Medical Center
Cavite
Davao Medical School Foundation
Davao City
St. Paul's Hospital Iloilo
Iloilo City
Healthcube Medical Clinic
Mandaluyong
Medical Center Manila
Manila
Philippine General Hospital
Manila
Indonesia5 sites
RS Universitas Indonesia
Depok
RS YARSI
Jakarta
RSIJ Cempaka Putih
Jakarta
RSUP Persahabatan
Jakarta
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta
United Arab Emirates4 sites
Burjeel Medical City
Abu Dhabi
Life Care Hospital
Abu Dhabi
Medeor hospital
Abu Dhabi
AI Kuwait Hospital
Dubai
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
- Conditions
- COVID-19
- Being tested
- ABO1020, Placebo
- Keywords
- COVID-19, Omicron
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO1020Biological
Vaccine
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Test group 1: ABO1020 | Experimental | Intramuscularly inject 15 μg of ABO1020 into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively. Receives: Biological: ABO1020 |
| Test group 2: Placebo | Placebo comparator | Intramuscularly inject 0 μg of placebo into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Phase 1/2, Incidence of solicited adverse events
Solicited adverse events 0 to 14 days after each dose
Measured: 0 to 14 days after each dose
In Phase 1/2, Incidence of unsolicited adverse events
Unsolicited adverse events 0 to 28 days after each dose
Measured: 0 to 28 days after each dose
In Phase 3, efficacy after the second dose
Confirmed COVID-19 cases occurring from 14 days after the second dose
Measured: 14 days after second dose
Secondary outcomes (4)
In Phase 1/2, titer of Anti-SARS-CoV-2 live virus neutralizing antibody
Evaluate the immunogenicity of ABO1020
Measured: 28 days after each dose and the corresponding ratio against Day 0 before the vaccination.
In Phase 1/2, Observation of Long-term Safety
Serious adverse events, adverse events of special interest and other medically attended adverse events through 12 months after each dose.
Measured: 12 months after each dose
In Phase 3, titer of Anti-SARS-CoV-2 live virus neutralizing antibody
Evaluate the immunogenicity of ABO1020
Measured: 28 days after each dose, 90 days and 180 days after the second dose and the corresponding ratio against Day 0 before the vaccination.
In Phase 3, Observation of long-term Safety
Serious adverse events, adverse events of special interest through 12 months after each dose.
Measured: 12 months after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start23 Nov 2022
- Primary completion30 Apr 2023
- Study completion31 Jul 2024 (estimated)
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 COVID-19Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase1/2: 30 subjects will be randomized in a ratio of 2:1 to receive ABO1020 and placebo, intramuscularly injected in the lateral deltoid region of the upper arm according to the two doses immunization schedule on Day 0 and Day 28. Phase3: 15000 subjects will be randomized in a ratio of 1:1 to receive ABO1020 and placebo, intramuscularly injected in the lateral deltoid region of the upper arm according to the two doses immunization schedule on Day 0 and Day 28.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636319
- Sponsor's protocol ID
- ABO1020-301
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hannawi S, Wu XH, Villalobos RE, Burhan E, Lallaine Borra MD, Gupta RK, Aquitania GP, Ang BWC, Mae A Zabat G, Roa CC Jr, Zoleta-De Jesus L, Yu DD, Wang M, Wu Y, Song WJ, Ying B, Qin CF. Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial. Med. 2024 Oct 11;5(10):1282-1292.e3. doi: 10.1016/j.medj.2024.06.013. Epub 2024 Jul 17.
PubMed 39025066
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
- ClinicalTrials.gov ID
- NCT05636319
- Acronym / sponsor ID
- ABO1020-301
- Conditions
- COVID-19
- Keywords
- COVID-19, Omicron
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14,168 participants (actual)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase1/2: 30 subjects will be randomized in a ratio of 2:1 to receive ABO1020 and placebo, intramuscularly injected in the lateral deltoid region of the upper arm according to the two doses immunization schedule on Day 0 and Day 28. Phase3: 15000 subjects will be randomized in a ratio of 1:1 to receive ABO1020 and placebo, intramuscularly injected in the lateral deltoid region of the upper arm according to the two doses immunization schedule on Day 0 and Day 28.
| Arm | Type | Receives |
|---|---|---|
| Test group 1: ABO1020 | Experimental | Biological: ABO1020Intramuscularly inject 15 μg of ABO1020 into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively. |
| Test group 2: Placebo | Placebo comparator | Biological: PlaceboIntramuscularly inject 0 μg of placebo into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study.
- Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF.
- Subjects who have previously been fully vaccinated either by 2 or 3 doses of SARS-CoV-2 inactivated vaccine. The last dose of immunization should be >6 months before administration of the investigational products.
- Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
- Males and females with childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after completing the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device [IUD], condoms [male], diaphragm, and cervical cap).
Key exclusion criteria (20 listed)
- Positive SARS-CoV-2 rapid test at screening.
- Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS).
- Fever (axillary temperature or equivalent ≥ 37.3℃*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
- Abnormal vital signs (pulse < 60 bpm or > 100 bpm, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg when keeping awake) with clinical relevance.
- Do not remain overall healthy (i.e., has medically deteriorated significantly since receiving the two-dose vaccination, is anticipated to have fatal outcome of uncontrolled diseases within 12 months, and is not able to provide blood as specified by the trial with anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination.
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 |
|---|---|---|
| ABO1020Vaccine | Biological | Test group 1: ABO1020 |
| PlaceboPlacebo | Biological | Test group 2: Placebo |
Primary outcome
In Phase 1/2, Incidence of solicited adverse events
Time frame: 0 to 14 days after each dose
Solicited adverse events 0 to 14 days after each dose
In Phase 1/2, Incidence of unsolicited adverse events
Time frame: 0 to 28 days after each dose
Unsolicited adverse events 0 to 28 days after each dose
In Phase 3, efficacy after the second dose
Time frame: 14 days after second dose
Confirmed COVID-19 cases occurring from 14 days after the second dose
4 secondary outcomes
In Phase 1/2, titer of Anti-SARS-CoV-2 live virus neutralizing antibody
Time frame: 28 days after each dose and the corresponding ratio against Day 0 before the vaccination.
In Phase 1/2, Observation of Long-term Safety
Time frame: 12 months after each dose
In Phase 3, titer of Anti-SARS-CoV-2 live virus neutralizing antibody
Time frame: 28 days after each dose, 90 days and 180 days after the second dose and the corresponding ratio against Day 0 before the vaccination.
In Phase 3, Observation of long-term Safety
Time frame: 12 months after each dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Results publication: PubMed 39025066Hannawi S, Wu XH, Villalobos RE, Burhan E, Lallaine Borra MD, Gupta RK, Aquitania GP, Ang BWC, Mae A Zabat G, Roa CC Jr, Zoleta-De Jesus L, Yu DD, Wang M, Wu Y, Song WJ, Ying B, Qin CF. Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial. Med. 2024 Oct 11;5(10):1282-1292.e3. doi: 10.1016/j.medj.2024.06.013. Epub 2024 Jul 17.
- Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial, Med (2024), https://doi.org/10.1016/j.medj.2024.06.013Link provided by the sponsor.
- Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial, Med (2024), https://doi.org/10.1016/j.medj.2024.06.013Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ABO1020 in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. at 25 sites in 4 countries.
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 20 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Pakistan, Philippines, Indonesia, United Arab Emirates. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
In Phase 1/2, Incidence of solicited adverse events (time frame: 0 to 14 days after each dose). The study lists 3 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 NCT05636319, 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 7 Aug 2024.