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 364 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 (4)

VXC0-100 at Dose level 1

EXPERIMENTAL

Participants will receive VXCO-100 at Dose Level 1 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 1 on Month 6.

Biological: VXCO-100

VXC0-100 at Dose level 2

EXPERIMENTAL

Participants will receive VXCO-100 at Dose Level 2 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 2 on Month 6.

Biological: VXCO-100

VXC0-100 at Dose level 3

EXPERIMENTAL

Participants will receive VXCO-100 at Dose Level 3 via intramuscular (IM) injection on Day 1 and then an optional boost of VXCO-100 at Dose Level 3 on Month 6.

Interventions

VXCO-100Biological

Sterile suspension for injection

VXC0-100 at Dose level 1VXC0-100 at Dose level 2VXC0-100 at Dose level 3

COVID-19 mRNA vaccineBiological

Sterile suspension for injection

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
Medical Research Council, South Africa
Othercollaborator

Study Sites (2)

Perinatal HIV Research Unit (PHRU), Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, South Africa

HIV and other Infectious Diseases Research Unit (HIDRU), South African Medical Research Council

Botha’s Hill, KwaZulu-Natal, South Africa

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19Coronavirus Infections

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

Glenda Gray, MBChB, FC
Medical Research Council, South Africa
PRINCIPAL INVESTIGATOR
Ravindre Panchia, MBChB
Perinatal HIV Research Unit (PHRU)
PRINCIPAL INVESTIGATOR
Anusha Nana, BPharm
Perinatal HIV Research Unit (PHRU)
PRINCIPAL INVESTIGATOR
Mbalizethu Mntambo, MBChB
HIV and other Infectious Diseases Research Unit (HIDRU)
PRINCIPAL INVESTIGATOR

Enrollment

130 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 10, 2023

Study Start

August 4, 2023

Actual (reported)

Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (4)

VXC0-100 at Dose level 1

VXC0-100 at Dose level 2

VXC0-100 at Dose level 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

COVID-19 mRNA vaccine

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (3)

Study Arms (4)

VXC0-100 at Dose level 1

VXC0-100 at Dose level 2

VXC0-100 at Dose level 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

COVID-19 mRNA vaccine

You may not qualify if:

Data Sharing

Source record

Locations