Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 3:10 PM
Study NCT ID:
NCT04844268
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2021-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety, Reactogenicity and Immunogenicity of the VACCINE RNA MCTI CIMATEC HDT (HDT-301) Vaccine Against COVID-19
Sponsor:
SENAI CIMATEC
Organization:
Study Overview
Official Title:
Phase 1, Randomized, Double-Blind, Dose-Escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Nanoparticle Carrier-Formulated Self-Replicating Replicon RNA (repRNA) Vaccine in Healthy Adults
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
In this phase 1 dose-ranging study, 3 dosage cohorts (1 µg, 5 µg, 25 µg), 90 subjects will be randomized (4:1 ratio for active vaccine:placebo) with equal probability of receiving a two-dose schedule of the same concentration, 28 days (group 1) or 56 days (group 2 ) after the first dose, or, a single dose schedule (group 3). For each of the three cohorts, for safety reasons, 1 sentinel subject will be registered initially, and will be vaccinated with the experimental drug, and will be followed up until day 8 (seven days after the first dose). If any criterion for interruption does not occur by day 8, 4 more sentinel subjects will be recruited and included in the study.
This means that once the first sentinel subject must receive the study vaccine, of the 4 sentinel participants enrolled later, 3 will receive the vaccine and 1 will receive the placebo (0.9% sodium chloride solution). Only then, after the 7-day follow-up period of the last sentinel subject, if no stopping rule is identified, the recruitment and registration of the remaining 25 subjects will proceed.
After cohort 1 has been registered, cohort 2 will be registered in a similar manner, with the first sentinel subject being registered after a 7-day observation period followed by the vaccination of the last subject in cohort 1. Cohort 3 will be registered in a similar manner after cohort 2.
There is a placebo group in each cohort in order to compare and improve the assessment of causality of adverse events.
Double blinding was done to all cohorts. Subjects, clinical study staff, statisticians, and investigators were masked to treatment assignment. Laboratory staff that manipulates the vaccine and the placebo were not blinded.
This means that once the first sentinel subject must receive the study vaccine, of the 4 sentinel participants enrolled later, 3 will receive the vaccine and 1 will receive the placebo (0.9% sodium chloride solution). Only then, after the 7-day follow-up period of the last sentinel subject, if no stopping rule is identified, the recruitment and registration of the remaining 25 subjects will proceed.
After cohort 1 has been registered, cohort 2 will be registered in a similar manner, with the first sentinel subject being registered after a 7-day observation period followed by the vaccination of the last subject in cohort 1. Cohort 3 will be registered in a similar manner after cohort 2.
There is a placebo group in each cohort in order to compare and improve the assessment of causality of adverse events.
Double blinding was done to all cohorts. Subjects, clinical study staff, statisticians, and investigators were masked to treatment assignment. Laboratory staff that manipulates the vaccine and the placebo were not blinded.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: