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Safety and Immunogenicity of HDT-301 Targeting a SARS-CoV-2 Variant Spike Protein

NCT05132907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-10-23

No results posted yet for this study

Summary

This is Phase 1 study is to assess tolerability and immunogenicity of three dose levels of the investigational HDT-301 vaccine administered intramuscularly (IM), both in immunization-naïve participants and as a booster for those participants who previously received a SARS-CoV-2 vaccine.

Safety and tolerability will be the primary endpoint assessed by incidence of adverse events at each dose through 12 months after completion of the vaccination regimen (either one dose, or two doses provided 56 days apart). Immunogenicity evaluations will be conducted for pre-specified timepoints as secondary and exploratory endpoints.

Conditions

  • SARS-CoV2 Infection

Interventions

BIOLOGICAL

HDT-301

HDT-301 Investigational Vaccine (a Nanoparticle Carrier-Formulated Replicon RNA (repRNA-CoV2S))

Sponsors & Collaborators

  • Rainier Clinical Research Center

    collaborator OTHER

  • C3 Research Associates

    collaborator UNKNOWN

  • HDT Bio

    lead INDUSTRY

Principal Investigators

  • Steven G Reed, Ph.D · HDT Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-24
Primary Completion
2023-11-21
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132907 on ClinicalTrials.gov