NCT04932824

Brief Summary

To develop an effective vaccine against the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, Clover Biopharmaceuticals is conducting a Phase 1 study (CLO-SCB-2019-001) in healthy volunteers to evaluate the safety and immunogenicity of SCB-2019, a recombinant SARS-CoV-2 trimeric Spike protein (S-protein) subunit vaccine. This study, CLO-SCB-2019-002, will be a long-term follow-up study for subjects who have completed CLO-SCB-2019-001 in order to assess longer safety and immunogenicity up to 24 months after the 1st dose of vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

April 13, 2021

Last Update Submit

January 28, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

  • Incidence of AESIs and SAEs

    To evaluate the safety profile of SCB-2019 up to 24 months after the 1st vaccination dose

    from 6 to 24 months after the 1st vaccination dose

  • Incidence of AESIs and SAEs

    To evaluate the safety profile of SCB-2019 up to 12 months after booster dose

    up to 12 months after booster dose

  • Serum anti-SCB-2019 IgG antibody titers

    To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 24 months after the 1st vaccination dose

    from 6 to 24 months after the 1st vaccination dose

  • Serum anti-SCB-2019 IgG antibody titers

    To describe and compare antibody response kinetics in response to vaccination with SCB-2019 up to 12 months after booster dose

    up to 12 months after booster dose

Secondary Outcomes (2)

  • Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)

    from 6 to 24 months after the 1st vaccination dose

  • Serum anti-SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based)

    up to 12 months after booster dose

Study Arms (3)

Subjects Without Treatment Cross-over

NO INTERVENTION

these subjects will not receive any vaccination during this study.

Subjects With Treatment Cross-over (From 1st Dose of Active Study Vaccine Onwards)

EXPERIMENTAL

Once the treatment assignments of study CLO-SCB-2019-001 are unblinded, those subjects who have received placebo and provided there is active study vaccine available, will be given the option to receive 2 doses of active study vaccine 21 days apart (ie, treatment cross-over)

Biological: SCB-2019

Subjects who will receive Booster Vaccine

EXPERIMENTAL

For subjects out of those who received SCB-2019 CpG/Alum-adjuvanted vaccine in study CLO-SCB-2019-001: the subjects will receive a booster dose.

Biological: SCB-2019

Interventions

SCB-2019BIOLOGICAL

a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.

Subjects With Treatment Cross-over (From 1st Dose of Active Study Vaccine Onwards)Subjects who will receive Booster Vaccine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects from study CLO-SCB-2019-001 will automatically move on to this long-term follow-up study if: 1) They have given informed consent for this follow-up study; and 2) They have completed the D184 visit of study CLO-SCB-2019-001 (ie, 6 months post the 1 st vaccination).

You may not qualify if:

  • All subjects who did not participate and completed the study or did not signed the inform consent for this follow up study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Nedlands, Territory Western Australia, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

SCB-2019 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

April 13, 2021

First Posted

June 21, 2021

Study Start

January 19, 2021

Primary Completion

November 10, 2021

Study Completion

December 16, 2021

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

AU(1)