SARS-CoV-2 InfectionPhase 3NCT05534035
Booster Superiority Study of PTX-COVID19-B Compared to Vaxzevria® in Adults Aged 18 Years and Older
A Phase 3 study testing PTX-COVID19-B and Vaxzevria® in people with SARS-CoV-2 Infection, run by Everest Medicines (Singapore) Pte. Ltd..
Trial summary
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®. 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 Infection
- What is being tested?
- PTX-COVID19-B and Vaxzevria®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2023to 18 Oct 2023
- 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
- Subject is willing and able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
- Adult males and females 18 years of age or older on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place) in general good health before study participation with no clinically relevant abnormalities (at Investigator's discretion) that could interfere with study assessments. Subjects may have stable comorbidities (no change in medications, exacerbations, or hospitalizations in the past 3 months).
- Documented evidence of previous primary vaccination with 2 doses of Vaxzevria® at least 3 months prior to the ICF date.
- SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening.
- Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening.
- Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception (i.e., including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral [in combination with male condoms with spermicide], transdermal, implant, or injection, barrier [i.e., condom, diaphragm with spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile partner; or abstinence) during the study or 6 months after the last study vaccine, whichever later.
Show all 9Show fewer
- A female subject is considered a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile.
- Subjects not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as subject confirmed: i. Surgical sterilization (e.g., bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery [Essure System® is not acceptable], hysterectomy, or tubal ligation). ii. Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening); if postmenopausal status is unclear, pregnancy tests will be performed prior to vaccinations.
- WOCBP must have a negative pregnancy test before vaccination. If menopausal status is unclear, a pregnancy test is required.
Who cannot join
- Individuals who are antigen positive, seropositive or reverse transcriptase polymerase chain reaction (RT-PCR) positive for SARSCoV-2.
- Women currently pregnant, lactating, or planning a pregnancy within 3 months post boost vaccine.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Receipt of an organ or bone marrow transplant; or Long-term (>2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed).
- History of Guillain-Barré Syndrome or any degenerative neurology disorder, or myocarditis, pericarditis.
- History of anaphylactic-type reaction to any injected vaccines; or known or suspected hypersensitivity to 1 or more of the components of the vaccine.
Show all 20Show fewer
- Acute illness or fever (axillary temperature ≥ 37.5ºC or oral temperature ≥ 38.0ºC) within 3 days (72 hours) before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator).
- Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
- Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment or expected blood donation during the study.
- Individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study.
- Receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study.
- Ineligible for the study based on the assessment of investigator.
- Suspected or known current alcohol or drug dependency within 12 months of screening.
- Individuals who are using medications with the intention of COVID-19 prophylaxis and who received or voluntarily plan to receive any other COVID-19 booster vaccine other than the study vaccines.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
- Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- Bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran and edoxaban).
- History of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2) or cerebral venous sinus thrombosis, increased risk for cerebrovascular venous and sinus thrombosis, history of immune thrombocytopenia, or a history of capillary leak syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated With Vaxzevria®
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®.
This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- PTX-COVID19-B, Vaxzevria®
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-COVID19-BBiological
The vaccine product, PTX-COVID19-B, is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) dispersion in an aqueous cryoprotectant buffer intended for IM injection.
Vaxzevria®Biological
The AstraZeneca COVID-19 Vaccine is a colorless to slightly brown solution, clear to slightly opaque with a pH of 6.6. One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 1010 viral particles (vp) (corresponding to not less than 2.5 × 108 ifu).
| Study group | Role | What they receive |
|---|---|---|
| PTX-COVID19-B | Experimental | Not described Receives: Biological: PTX-COVID19-B |
| Vaxzevria® | Active comparator | Not described Receives: Biological: Vaxzevria® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity Response
To demonstrate that the immune response of a single booster dose of PTXCOVID19-B is superior to that of Vaxzevria® at Day 15 in adults 18 years of age and older.
Measured: Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start3 Feb 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion18 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (Singapore) Pte. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534035
- Sponsor's protocol ID
- COVI-EM-001
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated With Vaxzevria®
- ClinicalTrials.gov ID
- NCT05534035
- Acronym / sponsor ID
- COVI-EM-001
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Everest Medicines (Singapore) Pte. Ltd.University, hospital or other
- Study start
- 3 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 18 Oct 2023 (estimated)
- First posted
- 9 Sep 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.
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®.
This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
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 |
|---|---|---|
| PTX-COVID19-B | Experimental | Biological: PTX-COVID19-B |
| Vaxzevria® | Active comparator | Biological: Vaxzevria® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is willing and able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
- Adult males and females 18 years of age or older on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place) in general good health before study participation with no clinically relevant abnormalities (at Investigator's discretion) that could interfere with study assessments. Subjects may have stable comorbidities (no change in medications, exacerbations, or hospitalizations in the past 3 months).
- Documented evidence of previous primary vaccination with 2 doses of Vaxzevria® at least 3 months prior to the ICF date.
- SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR)-negative at screening.
- Body mass index of ≥ 18 and ≤ 30 kg/m2 at screening.
Key exclusion criteria (20 listed)
- Individuals who are antigen positive, seropositive or reverse transcriptase polymerase chain reaction (RT-PCR) positive for SARSCoV-2.
- Women currently pregnant, lactating, or planning a pregnancy within 3 months post boost vaccine.
- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Receipt of an organ or bone marrow transplant; or Long-term (>2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed).
- History of Guillain-Barré Syndrome or any degenerative neurology disorder, or myocarditis, pericarditis.
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 |
|---|---|---|
| PTX-COVID19-BThe vaccine product, PTX-COVID19-B, is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) dispersion in an aqueous cryoprotectant buffer intended for IM injection. | Biological | PTX-COVID19-B |
| Vaxzevria®The AstraZeneca COVID-19 Vaccine is a colorless to slightly brown solution, clear to slightly opaque with a pH of 6.6. One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 1010 viral particles (vp) (corresponding to not less than 2.5 × 108 ifu). | Biological | Vaxzevria® |
Primary outcome
Immunogenicity Response
Time frame: Day15
To demonstrate that the immune response of a single booster dose of PTXCOVID19-B is superior to that of Vaxzevria® at Day 15 in adults 18 years of age and older.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for SARS-CoV-2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PTX-COVID19-B and Vaxzevria® in people with SARS-CoV-2 Infection, run by Everest Medicines (Singapore) Pte. Ltd..
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 9 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 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 Hazel Feng (+8613810347862, hazel.feng@everestmedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity Response (time frame: Day15). 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 9 Sep 2022.