COVID-19Phase 2NCT05542693

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

A Phase 2 study testing RNA MCTI CIMATEC HDT 5µg, RNA MCTI CIMATEC HDT 10µg and Covishield® - AstraZeneca in people with COVID-19 and COVID-19 Vaccine, run by Azidus Brasil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19, COVID-19 Vaccine
What is being tested?: RNA MCTI CIMATEC HDT 5µg, RNA MCTI CIMATEC HDT 10µg and Covishield® - AstraZeneca
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: No sites listed yet
Study dates: Jan 2023to Sep 2023
Phase: Phase 2
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Complete primary vaccination with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines, and at least one booster dose with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines. The last duration being at least 4 before the study duration.
Adult in a healthy condition or with a stable health status if pre-existing medical history.
Sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study
For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.

Who cannot join

History of COVID-19 in the 30 days before study enrollment.
Participation in other clinical studies in the last 12 (two) months.
Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
Blood donation up to 30 days before inclusion in the study;
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs.

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History of autoimmune disease or immunosuppression.
Rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site.
Body mass index (BMI) > 35.
Known or suspected drug or alcohol abuse in the last 6 months;
History of previous anaphylaxis or severe allergic reactions to the vaccine, products known to contain polyethene glycol (PEG) or unknown allergens.
History of myocarditis or carditis.

About this study

Official title: Phase IIb, Randomized, Double-blind, Non-inferior, Multicenter Study to Evaluate the Safety and Immunogenicity of the Self-replicating Nanoparticle Carrier Replicon RNA Carrier (repRNA) Vaccine in Adults 18 to 65 Years of Age

A multicenter, randomized, double-blind, active comparator, non-inferiority, multicenter IIb clinical trial to compare the safety and immunogenicity of two dose levels of the MCTI CIMATEC HDT RNA Vaccine against two authorized COVID-19 vaccines in Brazil (Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca) in 300 participants. Each vaccine will be provided as a single booster vaccine in adults aged 18 to 65 years previously immunized with both vaccines (Comirnaty - Pfizer and Covishield - Oxford/Astrazen). The investigational product MCTI C HDT will be administered in one of the two doses evaluated (5µg and 10 µg). The comparator products will be Comirnaty - Pfizer and Covishield - Oxford/AstraZeneca. The primary outcomes will be the number of participants with a 2-fold increase or more on average by titers of neutralizing D64G pseudovirus strain (pNT50) and comparison of titers generated by 5µg and 10µg doses of MCTI-CIMATEC-HDT RNA Vaccine.

Conditions: COVID-19, COVID-19 Vaccine
Being tested: RNA MCTI CIMATEC HDT 5µg, RNA MCTI CIMATEC HDT 10µg, Covishield® - AstraZeneca, Comirnaty® - Pfizer
Medical subject headings: COVID-19

What participants receive

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

RNA MCTI CIMATEC HDT 5µgBiological
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
RNA MCTI CIMATEC HDT 10µgBiological
Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)
Covishield® - AstraZenecaBiological
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)
Comirnaty® - PfizerBiological
Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).

Study groups in NCT05542693
Study group	Role	What they receive
RNA MCTI CIMATEC HDT 5µg	Experimental	Intramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 5 µg of single-dose administration on day 1. Receives: Biological: RNA MCTI CIMATEC HDT 5µg
RNA MCTI CIMATEC HDT 10µg	Experimental	Intramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 10 µg of single-dose administration on day 1. Receives: Biological: RNA MCTI CIMATEC HDT 10µg
Covishield® - AstraZeneca	Active comparator	Intramuscular injections of vaccine Covishield® - AstraZeneca at a usual dose of single-dose administration on day 1. Receives: Biological: Covishield® - AstraZeneca
Comirnaty® - Pfizer	Active comparator	Intramuscular injections of vaccine Comirnaty® - Pfizer at a usual dose of single-dose administration on day 1. Receives: Biological: Comirnaty® - Pfizer

What is being measured

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

Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority)
Proportion of participants with a 2-fold or greater increase in geometric mean neutralizing antibody titers against D614G pseudovirus strain (pNT50).
Measured: Day 29 after vaccination until day 181.
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination)
Comparison of antibody titers generated by 5µg and 10µg doses of the MCTI-CIMATEC-HDT RNA Vaccine
Measured: Day 29 after vaccination until day 181.

Timeline

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

Jan 2023Sep 2023

First posted15 Sep 2022
Study startJan 2023 (estimated)
Primary completionMar 2023 (estimated)
Study completionSep 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05542693
Sponsor's protocol ID: RNA-MCTI-CIMATEC-HDT-002
Status last verified: Sep 2022
First submitted: 26 Aug 2022
Last updated: 15 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIb, Randomized, Double-blind, Non-inferior, Multicenter Study to Evaluate the Safety and Immunogenicity of the Self-replicating Nanoparticle Carrier Replicon RNA Carrier (repRNA) Vaccine in Adults 18 to 65 Years of Age
ClinicalTrials.gov ID: NCT05542693
Acronym / sponsor ID: RNA-MCTI-CIMATEC-HDT-002
Conditions: COVID-19, COVID-19 Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Collaborators: SENAI CIMATEC
Study start: Jan 2023 (estimated)
Primary completion: Mar 2023 (estimated)
Study completion: Sep 2023 (estimated)
First posted: 15 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
RNA MCTI CIMATEC HDT 5µg	Experimental	Biological: RNA MCTI CIMATEC HDT 5µgIntramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 5 µg of single-dose administration on day 1.
RNA MCTI CIMATEC HDT 10µg	Experimental	Biological: RNA MCTI CIMATEC HDT 10µgIntramuscular injections of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT) at a dose of 10 µg of single-dose administration on day 1.
Covishield® - AstraZeneca	Active comparator	Biological: Covishield® - AstraZenecaIntramuscular injections of vaccine Covishield® - AstraZeneca at a usual dose of single-dose administration on day 1.
Comirnaty® - Pfizer	Active comparator	Biological: Comirnaty® - PfizerIntramuscular injections of vaccine Comirnaty® - Pfizer at a usual dose of single-dose administration on day 1.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years
Complete primary vaccination with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines, and at least one booster dose with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines. The last duration being at least 4 before the study duration.
Adult in a healthy condition or with a stable health status if pre-existing medical history.
Sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study
For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.

Key exclusion criteria (12 listed)

History of COVID-19 in the 30 days before study enrollment.
Participation in other clinical studies in the last 12 (two) months.
Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
Blood donation up to 30 days before inclusion in the study;

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
RNA MCTI CIMATEC HDT 5µgAdults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)	Biological	RNA MCTI CIMATEC HDT 5µg
RNA MCTI CIMATEC HDT 10µgAdults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)	Biological	RNA MCTI CIMATEC HDT 10µg
Covishield® - AstraZenecaAdults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)	Biological	Covishield® - AstraZeneca
Comirnaty® - PfizerAdults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).	Biological	Comirnaty® - Pfizer

Primary outcome

Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority)
Time frame: Day 29 after vaccination until day 181.
Proportion of participants with a 2-fold or greater increase in geometric mean neutralizing antibody titers against D614G pseudovirus strain (pNT50).
Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination)
Time frame: Day 29 after vaccination until day 181.
Comparison of antibody titers generated by 5µg and 10µg doses of the MCTI-CIMATEC-HDT RNA Vaccine

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RNA MCTI CIMATEC HDT 5µg, RNA MCTI CIMATEC HDT 10µg and Covishield® - AstraZeneca in people with COVID-19 and COVID-19 Vaccine, run by Azidus Brasil.

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 12 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 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority) (time frame: Day 29 after vaccination until day 181.). 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 NCT05542693.

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 15 Sep 2022.