A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA… (NCT05636319) | Clinical Trial Compass
UnknownPhase 2/3
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine
Indonesia, Pakistan, Philippines14,168 participantsStarted 2022-11-23
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
In Phase 1/2, Incidence of solicited adverse events
Timeframe: 0 to 14 days after each dose
2
In Phase 1/2, Incidence of unsolicited adverse events
. 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.
. 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.