SCB-1019T for Respiratory Syncytial Virus

Recruiting at 4 trial locations

Overseen By Xuesong Pei, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Clover Biopharmaceuticals USA, LLC

Disqualifiers: Acute disease, Neurological disorders, Dementia, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, SCB-1019T, designed to protect older adults against respiratory syncytial virus (RSV). The study compares low and high doses of SCB-1019T with an existing vaccine, AREXVY, and a placebo to assess safety and effectiveness. Ideal participants are 60 to 85 years old, have already received the AREXVY vaccine, and are in good health with stable medical conditions. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants with stable medical conditions can be included, suggesting that you might not need to stop your medications if your condition is stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SCB-1019T appears safe for humans based on earlier studies. Compared to another vaccine, AREXVY, SCB-1019T resulted in fewer local side effects. Specifically, only 16.7% of participants reported minor side effects with SCB-1019T, while 76.7% of those receiving AREXVY did. This suggests SCB-1019T is well-tolerated.

Previous tests on a similar treatment, a monoclonal antibody (a lab-made protein that mimics the immune system), also demonstrated good safety in infants, with only a few minor side effects noted.

Since SCB-1019T is in the early trial stage, its safety remains under close observation. Early trials primarily focus on safety and are carefully monitored. So far, the data appears promising, but ongoing research will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SCB-1019T for respiratory syncytial virus (RSV) because it offers a novel approach compared to existing treatments like palivizumab and ribavirin. SCB-1019T operates on a unique mechanism that focuses on enhancing the body's immune response to fight RSV more effectively. Unlike traditional treatments that often require multiple doses over time, SCB-1019T has the potential to be effective with a single dose, which could simplify treatment and improve patient adherence. Additionally, its active ingredient is designed to target RSV specifically, potentially leading to fewer side effects and a more targeted attack on the virus.

What evidence suggests that this trial's treatments could be effective for Respiratory Syncytial Virus?

Research shows that SCB-1019T targets a protein in the Respiratory Syncytial Virus (RSV), potentially preventing respiratory infections. In studies, SCB-1019T produced promising results by creating immune responses similar to AREXVY, a well-known RSV vaccine. Specifically, SCB-1019T generated antibody levels of about 32,000 IU/mL, closely matching AREXVY's 37,700 IU/mL. In this trial, participants will receive either a low or high dose of SCB-1019T, AREXVY, or a placebo. These results suggest that SCB-1019T has strong potential to protect against RSV infections, similar to existing vaccines. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 60-85 who previously received the AREXVY vaccine. Participants must be able to consent, follow the study plan, and have stable pre-existing medical conditions without significant treatment changes or hospitalization in the past 3 months.

Inclusion Criteria

I am healthy or have stable health conditions.

I need to check the full list of requirements in the study protocol.

I am willing and able to follow all study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SCB-1019T, AREXVY, or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SCB-1019T

Trial Overview The SCB-1019T vaccine is being tested for its safety and ability to provoke an immune response (immunogenicity) when given as a revaccination to older adults who had earlier been vaccinated with AREXVY.

How Is the Trial Designed?

Group I: Group 2 (SCB-1019T) Experimental Treatment 1 Intervention

50 adults to receive high dose SCB-1019T at Day 1

Group II: Group 1 (SCB-1019T) Experimental Treatment 1 Intervention

50 adults to receive low dose SCB-1019T at Day 1

Group III: Group 3 (AREXVY) Active Control 1 Intervention

50 adults to receive AREXVY at Day 1

Group IV: Group 4 (Placebo) Placebo Group 1 Intervention

10 adults to receive Placebo at Day 1

Who Is Running the Clinical Trial?

Clover Biopharmaceuticals USA, LLC

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

In a trial involving 43 infants at risk for RSV, the monoclonal antibody SB 209763 showed a good safety profile with only a few adverse events related to the drug, indicating it is generally safe for use in this population.

While SB 209763 demonstrated some ability to increase neutralization and fusion inhibition titers, it did not significantly reduce the incidence of RSV infections compared to placebo, suggesting that higher doses may be needed for effective protection against RSV lower respiratory tract disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and pharmacokinetics of an intramuscular monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants and young children at risk for severe RSV disease. Meissner, HC., Groothuis, JR., Rodriguez, WJ., et al.[2020]

The investigational ChAd155-RSV vaccine was found to have a safety profile similar to other childhood vaccines, with most adverse events occurring at rates comparable to or lower than those of active comparators.

The vaccine induced a strong immune response in infants, with higher RSV neutralizing titers and antibody concentrations compared to the comparator group, and there was no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. Sáez-Llorens, X., Norero, X., Mussi-Pinhata, MM., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06194318

Study Details | NCT06194318 | First-in-human Safety and ... Developed by GSK, it targets the prefusion F glycoprotein to protect against lower respiratory tract disease caused by RSV. Participant Group/Arm, Placebo ...

2. withpower.com withpower.com/trial/phase-1-respiratory-syncytial-virus-infections-2-2025-fb874

SCB-1019T for Respiratory Syncytial Virus Research shows that treatments like salbutamol, which is similar to SCB-1019T, have been effective in improving breathing in infants with RSV. Studies have ...

3. clival.com clival.com/news/clover-biopharmaceuticals-reports-positive-early-data-for-combination-respiratory-vaccine-candidates

Clover Biopharmaceuticals Reports Positive Early Data for ... Key findings include: · RSV immune responses: Both SCB-1022 and SCB-1033 generated approximately 6–8-fold increases in RSV-A and RSV-B ...

4. synapse.patsnap.com synapse.patsnap.com/article/clover-reports-positive-results-for-rsv-vaccine-scb-1019-in-comparison-with-gsks-arexvy

Clover Reports Positive Results for RSV Vaccine SCB- ... For RSV-B, SCB-1019 prompted GMTs of about 32,000 IU/mL, closely following AREXVY's 37,700 IU/mL and vastly outpacing the placebo's 2,900 IU/mL.

5. cloverbiopharma.com cloverbiopharma.com/media/178.html

Clover Announces Positive Clinical Data for RSV Vaccine ... “We are pleased to announce positive head-to-head clinical data for our non-adjuvanted SCB-1019 RSV vaccine candidate compared to AS01E-adjuvanted AREXVY, ...

6. ctv.veeva.com ctv.veeva.com/study/safety-and-immunogenicity-study-of-scb-1019t-in-children

Safety and Immunogenicity Study of SCB-1019T in Children This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/condition/25023/respiratory-syncytial-virus-rsv

Respiratory Syncytial Virus Rsv Clinical Research Trials Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults. The study design will compare heterologous revaccination with SCB-1019T ...

8. firstwordpharma.com firstwordpharma.com/story/5907395

Clover's RSV vaccine shows mettle in early-stage face-off ... In terms of safety, SCB-1019 showed a significantly lower rate of local adverse events compared with Arexvy (16.7% vs 76.7%) and was generally ...