Trials Sponsors Conditions Drugs Pricing

Conditions

SARS-CoV SARS-CoV-2

Keywords

Covid-19SARS-CoV-2CoronavirusVaccineSarbecovirusesCovid

Outcome Measures

Primary Outcomes (4)

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 Outcomes (3)

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
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

Study Arms (6)

VXCO-100 Group 1

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 2

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection

Biological: VXCO-100

VXCO-100 Group 3

EXPERIMENTAL

Participants 18-55 years of age will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection

Interventions

VXCO-100Biological

Sterile liquid for injection

VXCO-100 Group 1VXCO-100 Group 2VXCO-100 Group 3VXCO-100 Group 4VXCO-100 Group 5VXCO-100 Group 6

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

A participant must meet all the following criteria to be eligible for the study:
Adults ages 18 years and older.

Sponsors & Collaborators

Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company
Industrylead

Study Sites (3)

The Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

University of Maryland, Baltimore, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

University of Rochester Medical Center - Vaccine Research Unit

Rochester, New York, 14642, United States

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

Justin Ortiz, MD, MS
University of Maryland
PRINCIPAL INVESTIGATOR
Nadine Rouphael, MD
Emory University
PRINCIPAL INVESTIGATOR
Angela Branche, MD
University of Rochester
PRINCIPAL INVESTIGATOR

Enrollment

121 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 23, 2023

Study Start

May 11, 2023

Actual (reported)

Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (6)

VXCO-100 Group 1

VXCO-100 Group 2

VXCO-100 Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

VXCO-100 Group 4

VXCO-100 Group 5

VXCO-100 Group 6

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (6)

VXCO-100 Group 1

VXCO-100 Group 2

VXCO-100 Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

VXCO-100 Group 4

VXCO-100 Group 5

VXCO-100 Group 6

You may not qualify if:

Data Sharing

Source record

Locations