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Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

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

NCT05542693•Azidus Brasil

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age ≥ 18 years
•2. 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.
•3. Adult in a healthy condition or with a stable health status if pre-existing medical history.
•4. 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
•5. For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.

Exclusion Criteria

•1. History of COVID-19 in the 30 days before study enrollment.
•2. Participation in other clinical studies in the last 12 (two) months.
•3. Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
•4. Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
•5. Blood donation up to 30 days before inclusion in the study;
•6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs.
•7. History of autoimmune disease or immunosuppression.
•8. Rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site.
•9. Body mass index (BMI) \> 35.
•10. Known or suspected drug or alcohol abuse in the last 6 months;
+2 more criteria

Key Dates

Start Date

January 1, 2023

Primary Completion Date

March 1, 2023

Completion Date

September 1, 2023

Last Updated

September 15, 2022

Enrollment

300

ESTIMATED participants

Conditions

COVID-19COVID-19 Vaccine

Interventions

RNA MCTI CIMATEC HDT 5µg

BIOLOGICAL

RNA MCTI CIMATEC HDT 10µg

BIOLOGICAL

Covishield® - AstraZeneca

BIOLOGICAL

Comirnaty® - Pfizer

BIOLOGICAL

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COVID-19

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

Inclusion Criteria

Exclusion Criteria

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