A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Healthy Adults in the United States
Overview
- Phase
- Phase 1
- Intervention
- VXCO-100
- Conditions
- SARS-CoV
- Sponsor
- Vaccine Company, Inc.
- Enrollment
- 121
- Locations
- 3
- Primary Endpoint
- Number and percentage of participants with solicited local adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults.
Detailed Description
This is a phase 1, multisite clinical trial to evaluate the safety and immunogenicity of 3 dose levels of VXCO-100 in healthy adult volunteers. Participants will be vaccinated with 1 dose of VXCO-100 on Day 1. A subset of participants will be offered an optional interim boost at month 3. Safety will be evaluated 1) before proceeding to a higher dose level and 2) prior to enrollment of participants aged 56 years and older at a particular dose level.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
VXCO-100 Group 1
Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
Intervention: VXCO-100
VXCO-100 Group 2
Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Intervention: VXCO-100
VXCO-100 Group 3
Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Intervention: VXCO-100
VXCO-100 Group 4
Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection
Intervention: VXCO-100
VXCO-100 Group 5
Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection
Intervention: VXCO-100
VXCO-100 Group 6
Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
Intervention: VXCO-100
Outcomes
Primary Outcomes
Number and percentage of participants with solicited local adverse events
Time Frame: For 7 days after each product administration
Number and percentage of participants with solicited systemic adverse events
Time Frame: For 7 days after each product administration
Number and percentage of participants with unsolicited and safety laboratory-based adverse events
Time Frame: For 28 days after each product administration
Numbers and percentages of participants with serious adverse events (SAEs) including suspected unexpected serious adverse reactions (SUSARs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs)
Time Frame: For up to 304 days after each product administration
Secondary Outcomes
- Numbers and percentages of participants with positive Th1 or Th2 cytokine responses for CD4 and CD8 as measured by multi-parameter intracellular cytokine staining(At baseline and 7 days after each product administration)
- Response rate measured by geometric mean titer of the serum neutralizing antibody (Nab) against the ancestral (Wuhan) strain(At baseline and 21 days after each product administration)
- Response rate measured by GMT of Nab against selected variants of concern(At baseline and 21 days after each product administration)