First-in-human Safety and Immunogenicity Study of SCB-1019 in Healthy Adults

Respiratory Syncytial Virus Infection Clinical Trial

Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1019 in Healthy Adults

Status Recruiting

Clinical Trial Summary

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the bivalent SCB-1019 vaccine candidate with or without aluminium hydroxide in young adults (18-59 years) and older adults (60-85 years).

Clinical Trial Description

The study design includes an age- and dose-escalation (low/high dose) in two adult age groups (young adults [18-59 years] and older adults [60-85 years]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Detailed characterization of safety (including safety laboratory evaluation) and immune responses is planned. A placebo will be used as a control. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee. ;

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections

• NCT number: NCT06194318
• Study type: Interventional
• Source: Clover Biopharmaceuticals AUS Pty Ltd
• Contact: xuesong pei, MD
• Phone: 18515445890
• Email: xuesong.pei@cloverbiopharma.com
• Status: Recruiting
• Phase: Phase 1
• Start date: December 13, 2023
• Completion date: May 2025