Sanofi-GSK COVID-19 Vaccine Booster for Low Antibody Levels After Vaccination

(CPAT-SG Trial)

Recruiting in Chicago (>99 mi)

+5 other locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: CNI, Mycophenolate

Must not be taking: Anticoagulants, Immunomodulatory

Disqualifiers: Non-kidney transplant, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have =\<2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer \>2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does require that your immunosuppressive regimen includes specific drugs like CNI and mycophenolate, with or without a small dose of prednisone. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the Sanofi-GSK COVID-19 vaccine booster treatment?

The Sanofi-GSK COVID-19 vaccine booster, which includes the AS03 adjuvant, has been shown in a phase 3 study to be safe and to boost immune responses in adults who had previously received other authorized vaccines. This suggests it can effectively enhance protection against COVID-19, particularly for those with low antibody levels. ^{1 2 3 4 5}

Is the Sanofi-GSK COVID-19 Vaccine Booster safe for humans?

In a phase 3 study, the Sanofi-GSK COVID-19 Vaccine Booster, which includes the AS03 adjuvant, was evaluated for safety and showed no major safety concerns in adults who had previously received other COVID-19 vaccines. ^{1 6 7 8 9}

How does the Sanofi-GSK COVID-19 vaccine booster differ from other COVID-19 treatments?

The Sanofi-GSK COVID-19 vaccine booster is unique because it uses a monovalent formulation targeting the Beta variant (B.1.351) and includes the AS03 adjuvant, which enhances the immune response. This booster is designed to provide broad and durable protection against multiple variants of the virus, including Delta, Omicron, and even SARS-CoV-1, making it distinct from other vaccines that may not offer such wide-ranging cross-protection. ^{1 2 10 11 12}

Research Team

Christine Durand, MD

Principal Investigator

Johns Hopkins University

Dorry Segev, MD, Ph.D.

Principal Investigator

New York University Langone Health-Transplantation

Peter S Heeger, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai: Transplantation

Christian P. Larsen, MD, D.Phil.

Principal Investigator

Emory University School of Medicine: Transplantation

William A. Werbel, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Adult kidney transplant recipients who've had a full primary series and booster of mRNA COVID-19 vaccines but still have low antibody levels. They must be on stable immunosuppressants, not pregnant or breastfeeding, and agree to contraception if necessary. Excluded are those with severe illnesses, other organ transplants, certain infections like HIV, recent receipt of monoclonal antibodies or convalescent plasma, and unstable medical conditions.

Inclusion Criteria

I have completed 3 doses of either Moderna or Pfizer COVID-19 vaccine.

I understand the study and agree to participate.

My COVID-19 antibody levels are within the required range after vaccination and treatment.

Exclusion Criteria

You have had a severe allergic reaction to any of the ingredients in the vaccine before.

I have a bleeding disorder or have taken blood thinners in the last 21 days.

You have been diagnosed with COVID-19 since your last antibody test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine

Trial Overview The study is testing whether a Sanofi-GSK monovalent COVID-19 vaccine can boost the immune response in kidney transplant patients who didn't maintain high enough antibody levels after receiving mRNA vaccines. It's an open-label trial where all participants receive the vaccine without being compared to a control group.

Participant Groups

Group I: Kidney transplant recipients Experimental Treatment 1 Intervention

This single-arm trial will administer a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine to kidney transplant recipients who demonstrate a persistently low (=\< 2500 u/mL) anti-spike antibody response after completion of primary series and bivalent booster of either the Moderna COVID-19 Vaccine or the Pfizer-BioNTech Vaccine, as described in their respective Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs)

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Sanofi Pasteur, a Sanofi Company

Industry Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Findings from Research

The SCB-2019 vaccine, a protein subunit candidate for COVID-19, demonstrated an acceptable safety profile in a phase 2/3 trial involving 30,137 adult participants, with no significant safety concerns reported over a 6-month follow-up period.

Adverse events occurred at similar rates in both the SCB-2019 and placebo groups, indicating that the vaccine does not lead to increased risks compared to a placebo, and no vaccine-associated enhanced disease was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study. Hosain, R., Aquino, P., Baccarini, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

XBB.1.5 spike protein COVID-19 vaccine induces broadly neutralizing and cellular immune responses against EG.5.1 and emerging XBB variants. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of RQ3013, a broad-spectrum mRNA vaccine against SARS-CoV-2 variants. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Booster Doses of the SARS-CoV-2 Inactivated Vaccine KCONVAC against the Mutant Strains. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

SARS-CoV-2 vaccination in primary antibody deficiencies: an overview on efficacy, immunogenicity, durability of immune response and safety. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

S Trimer Derived from SARS-CoV-2 B.1.351 and B.1.618 Induced Effective Immune Response against Multiple SARS-CoV-2 Variants. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A prospective cohort study protocol: monitoring and surveillance of adverse events following heterologous booster doses of Oxford AstraZeneca COVID-19 vaccine in previous recipients of two doses of Sinopharm or Sputnik V vaccines in Iran. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Safety of BA.4-5 or BA.1 bivalent mRNA booster vaccines: nationwide cohort study. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naïve and exposed individuals in a phase 2/3, double-blind, randomized study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Protein-based SARS-CoV-2 spike vaccine booster increases cross-neutralization against SARS-CoV-2 variants of concern in non-human primates. [2022]