Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
- Registration Number
- NCT05870839
- Lead Sponsor
- Vaccine Company, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description VXCO-100 Group 1 VXCO-100 Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection VXCO-100 Group 2 VXCO-100 Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection VXCO-100 Group 3 VXCO-100 Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection VXCO-100 Group 4 VXCO-100 Participants 56+ years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection VXCO-100 Group 5 VXCO-100 Participants 56+ years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection VXCO-100 Group 6 VXCO-100 Participants 56+ years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection
- Primary Outcome Measures
Name Time Method Number and percentage of participants with solicited local adverse events For 7 days after each product administration Number and percentage of participants with solicited systemic adverse events For 7 days after each product administration Number and percentage of participants with unsolicited and safety laboratory-based adverse events 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) For up to 304 days after each product administration
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
University of Rochester Medical Center - Vaccine Research Unit
🇺🇸Rochester, New York, United States
The Hope Clinic of Emory University
🇺🇸Decatur, Georgia, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
🇺🇸Baltimore, Maryland, United States