Actively Recruiting

Phase Not Applicable
Age: 21Years - 45Years
All Genders
Healthy Volunteers
ID07412483

A Controlled Human Infection Model of Dengue to Study Clinical, Viral, and Immune Responses in Adults

Led by Tan Tock Seng Hospital · Updated on 2026-02-17

5

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

T

Tan Tock Seng Hospital

Lead Sponsor

A

A*Star

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop a safe controlled human infection model for dengue fever using an attenuated dengue virus serotype 3 (DEN3) in adult volunteers aged 21 to 45 years. It will analyze the clinical, viral, and immune responses to better understand dengue fever's pathophysiology. The study is designed to establish a reproducible infection in at least 80% of participants and to provide data to support future vaccine and treatment studies, including a planned follow-up dengue vaccine efficacy trial. Participants will receive a subcutaneous injection of a GMP-produced rDEN3delta30 virus, which is an attenuated form of the dengue virus developed by the National Institutes of Health. The study will monitor infection and immune responses in detail, including clinical symptoms, blood tests, and immune profiling. The challenge virus dose and safety protocols are based on prior studies conducted in the US. The study includes a quarantine period and follow-up evaluations to track viral kinetics and immune markers. During the study, participants will undergo regular clinical assessments, laboratory tests including blood samples, and safety monitoring from the day of viral challenge through at least 28 days post-inoculation, with longer-term immune response follow-up lasting up to three years. Researchers will measure occurrence and severity of adverse events, infection rates, viral load, symptom severity, and immune responses. The study requires contraception use during and after the trial for safety. Participation involves quarantine and multiple visits to collect data on dengue infection and immune responses.

CONDITIONS

Brief Title

A Controlled Human Infection Model of Dengue

Who Can Participate

Age: 21Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Adults aged 21 to 45 years inclusive
  • No known history of prior dengue, Zika, or other Orthoflavivirus infections
  • No prior vaccination for dengue, yellow fever, Japanese encephalitis, or other Orthoflavivirus
  • Suitable serology results from pre-screening
  • Female participants must agree to use contraception from 2 weeks before viral challenge until 1 month after the final dose, with negative pregnancy tests
  • Male participants must agree to use contraception from viral challenge date for 1 month and not donate sperm during this time
  • In good health with no significant medical conditions that could affect safety
  • Willing and able to commit to study participation
Not Eligible

You will not qualify if you...

  • History or evidence of significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • History of active depression, anxiety with severe psychiatric comorbidities, or psychiatric conditions affecting study cooperation
  • Significant history of drug or alcohol misuse
  • History of anaphylaxis or severe allergic reactions
  • Family history of sudden cardiac or unexplained death under age 50
  • Body weight  45kg or BMI  18 or  30 kg/m2
  • Inadequate venous access for blood draws
  • Significant abnormal findings in screening blood or urine tests
  • Positive tests for HIV, hepatitis B or C, or elevated HbA1C
  • Abnormal ECG findings
  • Receipt of live vaccine within 60 days or non-live vaccine within 30 days before viral challenge
  • Previous receipt of any flavivirus vaccine
  • Blood donation or loss of 550 mL or more within 3 months before or planned after viral challenge
  • Receipt of investigational drugs within 3 months before viral challenge
  • Use of systemic glucocorticoids or antiviral drugs within 6 months before viral challenge
  • Excessive use of over-the-counter medications before viral challenge
  • Receipt of chemotherapy, immunoglobulins, or immunosuppressive drugs at any time
  • Mentally or legally incapacitated
  • Females breastfeeding or pregnant within 6 months prior to study or positive pregnancy test at screening
  • First degree relative of any research team member
  • Any other investigator-determined reasons for unsuitability
  • Presence of infection symptoms or fever above 37.9C on day of viral challenge

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a subcutaneous injection of GMP-produced rDEN3delta30 virus to study the clinical, viral, and immune responses to dengue infection.

1 viral challenge visit (in-person)

Quarantine and Monitoring

Duration - 10 days

Participants are quarantined and closely monitored for dengue symptoms, viral load, and immune responses following the viral challenge.

Daily visits during quarantine (in-person)

Follow-up

Duration - Up to 28 days post-viral challenge

Participants attend follow-up visits to assess safety, adverse events, and immune responses up to 28 days after the viral challenge.

Approximately 3 to 4 visits (in-person)

Trial Site Locations

Total: 1 location

1

National Centre for Infectious Diseases (NCID)

Singapore, Singapore

Actively Recruiting

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Research Team

X

Xuan Ying Poh, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Published Research Related To This Trial

TV005 dengue vaccine protects against dengue serotypes 2 and 3 in two controlled human infection studies.

Kristen K Pierce, Anna P Durbin, Mary-Claire R Walsh...

https://pubmed.ncbi.nlm.nih.gov/37971871