Study to Assess Safety, Reactogenicity and Immunogenicity of the VACCINE RNA MCTI CIMATEC HDT (HDT-301) Vaccine Against COVID-19

Summary

This is a phase I, double-blind, placebo-controlled,dose-ranging clinical trial in healthy males and non-pregnant females, 18 to 55 years of age. The trial is designed to assess the safety, reactogenicity, and immunogenicity of VACCINE RNA MCTI CIMATEC HDT(HDT-301), which is a novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine that encodes for a full-length spike (S) protein of the SARS-CoV-2 virus. As a replicating mRNA vaccine, VACCINE RNA MCTI CIMATEC HDT(HDT-301) has the potential to allow the advantages of dose sparing, and possibly administration as a single dose, compared with other mRNA platforms.

Enrollment will occur at one domestic site. A total of 90 healthy subjects will receive multiple dosages of intramuscular (IM) injections of VACCINE RNA MCTI CIMATEC HDT(HDT-301). Participants will be enrolled sequentially in three dose cohorts (cohort 1 = 1 µg, cohort 2 = 5 µg, and cohort 3 = 25 µg), with each cohort consisting of a total of 30 subjects. Within each dose cohort, participants will be randomized (4:1 ratio for active vaccine:placebo) with equal probability of receiving a schedule of two doses, of the same concentration, on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3) VACCINE RNA MCTI CIMATEC HDT(HDT-301). The main objective is to evaluate the safety and reactogenicity of 3 dose vaccination schedule of VACCINE RNA MCTI CIMATEC HDT(HDT-301) and 1 dose of placebo in healthy adults.

Safety and tolerability will be the primary endpoint assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim immunogenicity evaluations will be conducted for pre-specified timepoints as secundary and exploratory endpoints.

Conditions

• SARS-CoV-2

Interventions

BIOLOGICAL

Cohort 1 VACCINE RNA MCTI CIMATEC HDT (HDT-301) vaccine

Intramuscular injections of 1 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT (HDT-301)) at a dose of 1 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).

BIOLOGICAL

Cohort 2 RNA VACCINE MCTI CIMATEC HDT(HDT-301) vaccine

Intramuscular injections of 5 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT(HDT-301)) at a dose of 5 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).

BIOLOGICAL

Cohort 3 VACCINE RNA MCTI CIMATEC HDT(HDT-301) vaccine

Intramuscular injections of 25 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACCINE RNA MCTI CIMATEC HDT(HDT-301)) at a dose of 25 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).

BIOLOGICAL

Placebo

Intramuscular (IM) injection of saline (0.9% sodium chloride) on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3), in each cohort.

Sponsors & Collaborators

• SENAI CIMATEC

  lead OTHER

Principal Investigators

• Roberto Badaró, PhD · Principal Investigator

• Steven Reed, PhD · Study collaborator

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-13

Primary Completion

2022-09-30

Completion

2022-10-31

Countries

• Brazil

Study Locations