Covid19 VaccinePhase 3NCT05011526
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults
A Phase 3 study testing MVC-COV1901 and AZD1222 in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 2 sites in Paraguay.
Trial summary
The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccine
- What is being tested?
- MVC-COV1901 and AZD1222
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 2 sitesParaguay
- Study dates
- 8 Oct 2021to 21 May 2022
- 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
- Male or female participant aged 18 years and above at randomization.
- Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
- Female participants:
- A female participant is eligible is the participant is a woman of non-childbearing potential, ie, surgically sterilized or one year post-menopausal.
- If the participant is a woman of childbearing potential, she must agree to practice sexual abstinence or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention.
- Have a negative pregnancy test
- Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
- Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Who cannot join
- Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
- Employees at the investigator's site, of the Sponsor or delegate who are directly involved in the conduct of the study.
- Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
- Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
- Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
- Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy within 12 weeks prior to the first dose of study intervention.
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- Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors within 12 weeks prior to the first dose of study intervention.
- Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
- Has received any other investigational or approved COVID-19 vaccine.
- Immunosuppressive illness or immunodeficient state.
- A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer.
- Bleeding disorder considered a contraindication to IM injection or phlebotomy.
- Known SARS-CoV-2 infection in the 3 months prior to the first dose of study intervention.
- A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint.
- A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901 or AZD1222.
- Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness within 2 days before the first dose of study intervention.
Trial locations and contacts
2 sites in 1 country.
Paraguay2 sites
Hospital Fundación Tesai
Ciudad del Este
Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo
About this study
Official title: A Phase III, Parallel Group, Prospective, Randomized, Double-blind, Active-controlled, Two-arm, Multi-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of MVC-COV1901 Compared to AZD1222 in Adults of 18 Years and Above
The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
Read the detailed description
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
- Conditions
- Covid19 Vaccine
- Being tested
- MVC-COV1901, AZD1222
- Keywords
- Covid19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVC-COV1901Biological
Approximately 471 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
AZD1222Biological
Approximately 471 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
| Study group | Role | What they receive |
|---|---|---|
| MVC-COV1901 | Experimental | S-2P protein with CpG and Aluminum Hydroxide/0.5mL Receives: Biological: MVC-COV1901 |
| AZD1222 | Experimental | ChAdOx1 nCoV-19 vaccine Receives: Biological: AZD1222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of neutralizing antibody (GMT ratio)
To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination
-GMT ratio
Measured: Day 1 to Day 43
Incidence of Adverse Event within 28 days post the second study intervention
To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination
The number and percentage of participants with the occurrence of:
- Solicited local AEs
- Solicited systemic AEs
- Unsolicited AEs
- Medically attended AEs (MAAEs)
- AESIs
- VAED
- SAEs
Measured: Day 1 to Day 57
Secondary outcomes (4)
Immunogenicity of neutralizing antibody (GMT)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209
- GMT
Measured: Day 29 to Day 209
Immunogenicity of neutralizing antibody(SCR)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209
- SCR
Measured: Day 29 to Day 209
Immunogenicity of neutralizing antibody(GMT ratio)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209
- GMT ratio
Measured: Day 29 to Day 209
Incidence of Adverse Event throughout study conduct
To evaluate the safety of MVC COV1901 compared to AZD1222 over the study period
The number and percentage of participants with the occurrence of:
- MAAEs
- AESIs
- VAED
- SAEs
Measured: Day 1 to 180 days after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start8 Oct 2021
- Primary completion28 Dec 2021
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 VaccineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Francisco Armoa Garcia, MD.Ph.D., Principal investigator, University of Asuncion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011526
- Sponsor's protocol ID
- CT-COV-31
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2021
- Last updated
- 30 Sep 2022
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Parallel Group, Prospective, Randomized, Double-blind, Active-controlled, Two-arm, Multi-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of MVC-COV1901 Compared to AZD1222 in Adults of 18 Years and Above
- ClinicalTrials.gov ID
- NCT05011526
- Acronym / sponsor ID
- CT-COV-31
- Conditions
- Covid19 Vaccine
- Keywords
- Covid19 Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 18 Aug 2021 (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 purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
Detailed description
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVC-COV1901 | Experimental | Biological: MVC-COV1901S-2P protein with CpG and Aluminum Hydroxide/0.5mL |
| AZD1222 | Experimental | Biological: AZD1222ChAdOx1 nCoV-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participant aged 18 years and above at randomization.
- Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
- Female participants:
- Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
- Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Key exclusion criteria (17 listed)
- Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
- Employees at the investigator's site, of the Sponsor or delegate who are directly involved in the conduct of the study.
- Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
- Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
- Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
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 |
|---|---|---|
| MVC-COV1901Approximately 471 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region | Biological | MVC-COV1901 |
| AZD1222Approximately 471 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region | Biological | AZD1222 |
Primary outcome
Immunogenicity of neutralizing antibody (GMT ratio)
Time frame: Day 1 to Day 43
To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination -GMT ratio
Incidence of Adverse Event within 28 days post the second study intervention
Time frame: Day 1 to Day 57
To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination The number and percentage of participants with the occurrence of: * Solicited local AEs * Solicited systemic AEs * Unsolicited AEs * Medically attended AEs (MAAEs) * AESIs * VAED * SAEs
4 secondary outcomes
Immunogenicity of neutralizing antibody (GMT)
Time frame: Day 29 to Day 209
Immunogenicity of neutralizing antibody(SCR)
Time frame: Day 29 to Day 209
Immunogenicity of neutralizing antibody(GMT ratio)
Time frame: Day 29 to Day 209
Incidence of Adverse Event throughout study conduct
Time frame: Day 1 to 180 days after second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- 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.
Luis Francisco Armoa Garcia, MD.Ph.D. principal investigator
University of Asuncion
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MVC-COV1901 and AZD1222 in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 2 sites in Paraguay.
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 17 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: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Paraguay. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity of neutralizing antibody (GMT ratio) (time frame: Day 1 to Day 43). The study lists 2 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 30 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.