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Singapore SARS-CoV-2 Human Challenge Study

NCT06654973 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal of this study is to conduct a safe SARS-CoV-2 Delta variant human infection challenge in adult healthy volunteers. The main objectives are to:

* Induce laboratory confirmed infection in up to 70% of participants
* Confirm the safety profile as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs) from the day of viral challenge (Day 0) up to Day 28 follow-up.

Participants will be given the GMP-produced Delta SARS-CoV-2 virus via intranasal drops using the optimized conditions established in the "Development of a SARS-CoV-2 Delta variant human infection challenge model" (COVHIC002) Human Challenge Study being conducted in the UK. A safe and well-tolerated human challenge model with the SARS-CoV-2 Delta variant will be established in Singapore. This model will be used to accelerate next-generation vaccine development and to determine the factors associated with altered clinical and virological outcomes; correlates of protection; and targets for the development of novel vaccines, therapeutics, and diagnostics.

Conditions

  • COVID 19

Interventions

OTHER

GMP-produced SARS-CoV-2 Delta strain

The challenge virus used in Sing-CoV study is the same as that used in COVHIC002 study. It was originally obtained in mid 2021 from a nose-throat swab from an otherwise healthy young adult with mild COVID-19 in the community. The procedure for isolation, storage, preparation, and administration of challenge virus in this study (Sing-CoV and COVHIC002) is the same as used in the first SARS-CoV-2 human challenge study (COVHIC001) at Imperial College London and the same as used in the COV-CHIM01 (NCT04864548) SARS-CoV-2 human challenge study at University of Oxford.

Sponsors & Collaborators

  • A*Star

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Barnaby E Young, MB BChir, PhD · National Centre for Infectious Diseases

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-12-29
Completion
2026-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654973 on ClinicalTrials.gov