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

Trial Summary

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.

What data supports the effectiveness of the drug SCB-1019T for treating 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 shown that salbutamol can help reduce symptoms and improve oxygen levels in children with respiratory issues. ^{1 2 3 4 5}

What safety data exists for SCB-1019T or similar treatments for RSV?

The research articles provided do not contain specific safety data for SCB-1019T or similar treatments for RSV. ^{6 7 8 9 10}

What is the purpose of this trial?

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Albuterol responsiveness in infants with respiratory failure caused by respiratory syncytial virus infection. [2019]

2. Turkey pubmed.ncbi.nlm.nih.gov

Emergency room management of acute bronchiolitis: a randomized trial of nebulized epinephrine. [2013]

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

Effect of inhaled nitric oxide on respiratory mechanics in ventilated infants with RSV bronchiolitis. [2020]

4. Brazil pubmed.ncbi.nlm.nih.gov

Use of helium-oxygen mixture (Heliox®) in the treatment of obstructive lower airway disease in a pediatric emergency department. [2020]

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

Dexamethasone in salbutamol-treated inpatients with acute bronchiolitis: a randomized, controlled trial. [2019]

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

1,4-Benzodiazepines as inhibitors of respiratory syncytial virus. [2011]

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

Safety and antiviral activity of motavizumab, a respiratory syncytial virus (RSV)-specific humanized monoclonal antibody, when administered to RSV-infected children. [2017]

8. United States 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. [2020]

9. United States 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. [2023]

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

Live Respiratory Syncytial Virus Attenuated by M2-2 Deletion and Stabilized Temperature Sensitivity Mutation 1030s Is a Promising Vaccine Candidate in Children. [2021]