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COVID-19 VaccinePhase 3NCT05426343

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222

A Phase 3 study testing MVC-COV1901 and AZD1222 in people with COVID-19 Vaccine, run by Medigen Vaccine Biologics Corp. at 1 site in Paraguay.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second… 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 Vaccine
What is being tested?
MVC-COV1901 and AZD1222
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteParaguay
Study dates
9 Jul 2022to 7 Jan 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

  • Male or female participant aged 18 years and above at randomization.
  • Healthy adult or adult with pre-existing medical conditions who is in a 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 participant:
  • A female participant is eligible if the participant is a woman of non-childbearing potential, i.e., surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) 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. Highly effective methods of contraception include:
  • Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing system ii. Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history).
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  • 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 breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention.
  • Employees at the investigator's site, of the Sponsor or delegate (e.g., contract research organization) 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 the 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 the study intervention.
  • Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention.
  • Currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention.
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  • Currently receiving or anticipate receiving treatment with tumor necrosis factor (TNF)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention.
  • Major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention.
  • Has received any other investigational or approved COVID-19 vaccine.
  • Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  • A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
  • Bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy.
  • Documented SARS-CoV-2 infection prior to the first dose of study intervention, or an individual with positive anti-SARS-CoV-2 antibody test at screening.
  • A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, or capillary leak 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. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
  • 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 (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

Trial locations and contacts

1 site in 1 country.

Paraguay1 site

  • Hospital Fundación Tesai

    Ciudad del Este

Other trials in Paraguay

About this study

Official title: A Phase III, Parallel-Group, Prospective, Randomized, Double-blind, Active-controlled, Two- Arm Study to Evaluate the Immunogenicity, Safety, and Tolerability of the MVC-COV1901 Compared to AZD1222 in Adult of 18 Years and Above.

The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.

Read the detailed description

This is a Phase III, parallel-group, prospective, randomized, double-blind, active-controlled, two- arm study to be conducted in approximately 250 participants aged 18 years and above who are generally healthy or with stable pre-existing medical conditions. The participants, investigators, the site personnel and the Sponsor staff who are involved in the blinded conduct of the study will be blinded to the study intervention assignment. Preparation and administration of the study intervention will be performed by authorized unblinded site personnel who do not participate in the evaluation of the participants.

Eligible participants will be randomized to receive either MVC-COV1901 or AZD1222 vaccine in a 1:1 ratio. Randomization of participants will be stratified by study site and age (≥ 18 to < 65 years and ≥ 65 years), at least 40% of the participants shall be ≥ 65 years.

Approximately 30 participants in the age 18 to <65 group and 10 participants in the age ≥ 65 years will be included in the CMI Subset for CMI assessments.

Being tested
MVC-COV1901, AZD1222
Keywords
COVID-19 Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVC-COV1901Biological

    Approximately 125 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 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

Study groups in NCT05426343
Study groupRoleWhat they receive
MVC-COV1901ExperimentalS-2P protein with CpG and Aluminum Hydroxide/0.5mL
Receives: Biological: MVC-COV1901
AZD1222Active comparatorn=ChAdOx1 nCoV-19 vaccine
Receives: Biological: AZD1222

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity of neutralizing antibody (GMT)

    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

  2. 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 Adverse Events

    Measured: Day 1 to 28 days post the second study intervention

Secondary outcomes (4)

  1. Immunogenicity of antigen-specific immunoglobulin (GMT)

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants

    -GMT

    Measured: Day 1 to Day 209

  2. Immunogenicity of antigen-specific immunoglobulin (SCR)

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants

    -SCR

    Measured: Day 1 to Day 209

  3. Immunogenicity of antigen-specific immunoglobulin(GMT ratio)

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants

    -GMT ratio

    Measured: Day 29 to Day 209

  4. 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 Adverse Events

    Measured: Day 1 to Day 209

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2022
  2. Study start9 Jul 2022
  3. Primary completion10 Oct 2022
  4. Study completion7 Jan 2023

Resources

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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426343
Sponsor's protocol ID
CT-COV-34
Status last verified
Jun 2022
First submitted
10 Jun 2022
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MVC-COV1901 and AZD1222 in people with COVID-19 Vaccine, run by Medigen Vaccine Biologics Corp. at 1 site 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 9 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 23 Oct 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 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) (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?

On the ClinicalTrials.gov record for NCT05426343.

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 23 Oct 2023.

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