Back to results

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

Primary Purpose

COVID-19, COVID-19 Vaccine

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

RNA MCTI CIMATEC HDT 5µg

RNA MCTI CIMATEC HDT 10µg

Covishield® - AstraZeneca

Comirnaty® - Pfizer

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

RNA MCTI CIMATEC HDT 5µg

RNA MCTI CIMATEC HDT 10µg

Covishield® - AstraZeneca

Comirnaty® - Pfizer

Arm Description

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.

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.

Intramuscular injections of vaccine Covishield® - AstraZeneca at a usual dose of single-dose administration on day 1.

Intramuscular injections of vaccine Comirnaty® - Pfizer at a usual dose of single-dose administration on day 1.

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05542693

First Posted

August 26, 2022

Last Updated

September 13, 2022

Sponsor

Azidus Brasil

Collaborators

SENAI CIMATEC

1. Study Identification

Unique Protocol Identification Number

NCT05542693

Brief Title

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2023 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azidus Brasil

Collaborators

SENAI CIMATEC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, COVID-19 Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RNA MCTI CIMATEC HDT 5µg

Arm Type

Experimental

Arm Description

Arm Title

RNA MCTI CIMATEC HDT 10µg

Arm Type

Experimental

Arm Description

Arm Title

Covishield® - AstraZeneca

Arm Type

Active Comparator

Arm Description

Intramuscular injections of vaccine Covishield® - AstraZeneca at a usual dose of single-dose administration on day 1.

Arm Title

Comirnaty® - Pfizer

Arm Type

Active Comparator

Arm Description

Intramuscular injections of vaccine Comirnaty® - Pfizer at a usual dose of single-dose administration on day 1.

Intervention Type

Biological

Intervention Name(s)

RNA MCTI CIMATEC HDT 5µg

Intervention Description

Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)

Intervention Type

Biological

Intervention Name(s)

RNA MCTI CIMATEC HDT 10µg

Intervention Description

Adults previously immunized will be randomized to receive a single booster vaccine: experimental (MCTI-CIMATEC-HDT RNA)

Intervention Type

Biological

Intervention Name(s)

Covishield® - AstraZeneca

Intervention Description

Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer)

Intervention Type

Biological

Intervention Name(s)

Comirnaty® - Pfizer

Intervention Description

Adults previously immunized will be randomized to receive a single booster vaccine comparator (Comirnaty - Pfizer and (Covishield - Oxford/Astrazen).

Primary Outcome Measure Information:

Title

Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Non-inferiority)

Description

Proportion of participants with a 2-fold or greater increase in geometric mean neutralizing antibody titers against D614G pseudovirus strain (pNT50).

Time Frame

Day 29 after vaccination until day 181.

Title

Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine (Dose determination)

Description

Comparison of antibody titers generated by 5µg and 10µg doses of the MCTI-CIMATEC-HDT RNA Vaccine

Time Frame

Day 29 after vaccination until day 181.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Immunogenicity of the RNA MCTI CIMATEC HDT Vaccine

We'll reach out to this number within 24 hrs