DenguePhase 1NCT05268302
Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4)
A Phase 1 study testing Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose and Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge in people with Dengue, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose and Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 4 Jan 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent
- Volunteers must be able to provide written informed consent.
- Volunteers must be healthy as established by medical history and clinical examination at study entry
- Volunteers must pass a comprehension test and be able to comply with all study requirements.
- Female volunteers of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).
- Female volunteers of childbearing potential may be enrolled in the study, if all the following apply:
Show all 9Show fewer
- Practiced adequate contraception for 30 days prior to challenge
- Has a negative urine pregnancy test on the day of DHIM
- Agrees to continue adequate contraception until two months after completion of the DHIM
Who cannot join
- History of dengue infection or dengue illness, or history of flavivirus infection or vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue) (Note: for the homologous rechallenge sub-study, criteria does not apply)
- Volunteers positive for antibodies to flaviviruses (FV) to include dengue virus, West Nile virus, Yellow Fever virus, Zika virus, and Japanese encephalitis virus. (Note: for the homologous rechallenge sub-study, criteria does not apply)
- Planned administration of any flavivirus vaccine for the entire study duration
- Any recent (within 4 weeks) or planned travel to any dengue endemic area while participating in the trial
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
- Volunteer seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)
Show all 32Show fewer
- Safety laboratory test results at screening that are deemed clinically significant or more than Grade 1 deviation from normal with the exception of PT/PTT, fibrinogen decrease, ALT/AST increase (acceptable to 1.1 ULN), platelet decrease which will be exclusionary at Grade 1 or higher
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- History of bipolar disorder, schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the volunteer from participating in the study
- Significant screening physical examination abnormalities at the discretion of the investigator, including a BMI > 35 kg/m2
- Planned administration or administration of a vaccine/product not planned in the study protocol during the period starting 30 days prior to the DHIM until 56 days after the study completion (routine influenza or COVID-19 vaccination will be allowed if it is not administered within 14 days preceding DHIM)
- Use of any investigational or non-registered product (drug or vaccine) other than the study DHIM during the period starting 30 days preceding the DHIM and/or planned use during the study period
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the DHIM (for corticosteroids, this will mean prednisone 5 mg/day or equivalent; inhaled, intranasal and topical steroids are allowed)
- Concurrently participating in another clinical study, at any time during the study period, in which the volunteer has been or will be exposed to an investigational or a noninvestigational product (pharmaceutical product or device)
- Autoimmune disease or history of autoimmune disease
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study product or related to a study procedure
- Major congenital defects or serious chronic illness
- History of any neurological disorders or seizures
- Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment: note that a volunteer with a minor illness such as mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator
- Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the DHIM or planned administration during the study period
- Recent history of chronic alcohol consumption (more than 2 drinks per day and/or drug abuse) based on volunteer reported history
- Pregnant or breastfeeding female or female currently planning to become pregnant or planning to discontinue adequate contraception
- Men who intend to father a child during the study period (approximately 2 months)
- Any religious or personal beliefs that bar the administration of blood products, transfusions or serum albumin
- Planned or current administration of an HMG-CoA reductase inhibitor (i.e., lovastatin, simvastatin, atorvastatin, etc.)
- Currently regularly taking anti-coagulant medication, aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs)
- Any other condition which, in the opinion of the investigator, prevents the volunteer from participating in the study
- Temporary Exclusion Criteria:
- Acute disease and/or fever (> 38°C/100.4°F oral body temperature) at the time or within 6 hours of challenge inoculation: note that a volunteer with a minor illness such as mild upper respiratory infection, etc., without fever, and with a negative SARS-CoV-2 upper respiratory (NP or nasal) swab PCR on the day of inoculation, may be enrolled at the discretion of the investigator.
- Recent blood donation (within prior 56 days).
- Recent or scheduled receipt of any live vaccine 30 days and/or inactivated or sub-unit vaccine 14 days prior to inoculation.
- Safety labs may be repeated once. If outside the 90-day screening window, the volunteer may be rescreened except for flavivirus, hepatitis, and HIV viral screens.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
Official title: Phase One, Open Label, Assessment of a Dengue-4-Virus-Live Virus Human Challenge - (DENV-4-LVHC) Virus Strain in Healthy U.S. Adults
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.
Read the detailed description
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help the research team to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue. The duration of participation will last for 180 days (six months) after challenge including up to 22 visits. After participants are exposed to the weakened dengue virus, the research team will follow them closely to measure their symptoms. Like the flu, participants might expect to have a headache, rash, body aches, fever and chills or they may experience no symptoms whatsoever. If participants do develop symptoms, the research team will monitor them closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur.
- Conditions
- Dengue
- Being tested
- Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose, Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low DoseBiological
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0.
Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous RechallengeBiological
Also called Homologous Rechallenge
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 366 in previously dosed participants.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Primary | Experimental | 0.95 x 10^2 Plaque Forming Units Receives: Biological: Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose |
| Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Homologous Rechallenge | Experimental | 0.95 x 10^2 Plaque Forming Units Receives: Biological: Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Injection Site Adverse Events
solicited injection site adverse events until 7 days post virus inoculation
Measured: Days 1-7 post-challenge
Number of Participants With Unsolicited Injection Site Adverse Events
unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Measured: Days 2, 4-16, 28
Number of Participants With Solicited Systemic Adverse Events
solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Measured: Days 2, 4-16, 28
Incidence of Abnormal Laboratory Measurements
Incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Measured: Days 2, 4-16, 28
Number of Participants With Dengue-Related Adverse Events
dengue-related like adverse events until 28 days post virus inoculation or 7 days post inpatient whichever is later
Measured: Days 2, 4-16, 28
Number of Participants With Unsolicited Systemic Adverse Events
unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Measured: Days 2, 4-16, 28
Number of Participants With Short-Term SAEs
Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Measured: Days 2, 4-16, 28
Number of Participants With Long-Term SAEs
Number of SAEs until 6 months post virus inoculation
Measured: Days 2, 4-16, 28, 180
Number of Participants With Fever
The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times at least 4 hours apart
Measured: Days 2, 4-16, 28, 180
Secondary outcomes (2)
Number of Participants With Detected Viremia
RNAemia measurement by PCR through Day 28 post-challenge. RNA detection is in Cycle threshold (Ct). Viremia is determined by the presence of dengue virus RNA through Day 28 post-challenge. (Was viremia detected?)
Measured: Days 2, 4-16, 28
Microneutrilization (50%) Geometric Mean Titer
Microneutrilization (50%) Geometric Mean Titer Dengue antibodies
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start28 Feb 2022
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Technology Enterprise Consortium (MTEC)
- Responsible party
- Principal investigator, Kirsten Lyke, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268302
- Sponsor's protocol ID
- HP-00087533
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2022
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chua JV, Price A, Sharaf S, Camacho Ortega S, Bernal PJ, Butler L, Koudjra AR, Joshi S, Hardy CSC, Currier JR, Waickman AT, Cairo C, Friberg H, Edelman R, Lyke KE. Novel dengue serotype 4 live virus human challenge: a phase 1 dose optimisation and homologous rechallenge study. Lancet Microbe. 2026 Oct 29:101542. doi: 10.1016/j.lanmic.2026.101542. Online ahead of print.
PubMed 42956783
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase One, Open Label, Assessment of a Dengue-4-Virus-Live Virus Human Challenge - (DENV-4-LVHC) Virus Strain in Healthy U.S. Adults
- ClinicalTrials.gov ID
- NCT05268302
- Acronym / sponsor ID
- HP-00087533
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Medical Technology Enterprise Consortium (MTEC)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.
Detailed description
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help the research team to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue. The duration of participation will last for 180 days (six months) after challenge including up to 22 visits. After participants are exposed to the weakened dengue virus, the research team will follow them closely to measure their symptoms. Like the flu, participants might expect to have a headache, rash, body aches, fever and chills or they may experience no symptoms whatsoever. If participants do develop symptoms, the research team will monitor them closely in a local hotel or a wing of our hospital to ensure safety and to treat symptoms if they occur.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Primary | Experimental | Biological: Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose0.95 x 10^2 Plaque Forming Units |
| Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Homologous Rechallenge | Experimental | Biological: Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge0.95 x 10^2 Plaque Forming Units |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or non-pregnant, non-breastfeeding female between 18 and 50 years of age (inclusive) at the time of consent
- Volunteers must be able to provide written informed consent.
- Volunteers must be healthy as established by medical history and clinical examination at study entry
- Volunteers must pass a comprehension test and be able to comply with all study requirements.
- Female volunteers of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).
Key exclusion criteria (32 listed)
- History of dengue infection or dengue illness, or history of flavivirus infection or vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue) (Note: for the homologous rechallenge sub-study, criteria does not apply)
- Volunteers positive for antibodies to flaviviruses (FV) to include dengue virus, West Nile virus, Yellow Fever virus, Zika virus, and Japanese encephalitis virus. (Note: for the homologous rechallenge sub-study, criteria does not apply)
- Planned administration of any flavivirus vaccine for the entire study duration
- Any recent (within 4 weeks) or planned travel to any dengue endemic area while participating in the trial
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low DoseLow dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0. | Biological | Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Primary |
| Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous RechallengeAlso: Homologous RechallengeLow dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 366 in previously dosed participants. | Biological | Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Homologous Rechallenge |
Primary outcome
Number of Participants With Solicited Injection Site Adverse Events
Time frame: Days 1-7 post-challenge
solicited injection site adverse events until 7 days post virus inoculation
Number of Participants With Unsolicited Injection Site Adverse Events
Time frame: Days 2, 4-16, 28
unsolicited injection site adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Participants With Solicited Systemic Adverse Events
Time frame: Days 2, 4-16, 28
solicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Incidence of Abnormal Laboratory Measurements
Time frame: Days 2, 4-16, 28
Incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Participants With Dengue-Related Adverse Events
Time frame: Days 2, 4-16, 28
dengue-related like adverse events until 28 days post virus inoculation or 7 days post inpatient whichever is later
Number of Participants With Unsolicited Systemic Adverse Events
Time frame: Days 2, 4-16, 28
unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Participants With Short-Term SAEs
Time frame: Days 2, 4-16, 28
Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Participants With Long-Term SAEs
Time frame: Days 2, 4-16, 28, 180
Number of SAEs until 6 months post virus inoculation
Number of Participants With Fever
Time frame: Days 2, 4-16, 28, 180
The occurrence of fever defined as greater than or equal to 38°C (100.4° F) measured at least 2 times at least 4 hours apart
2 secondary outcomes
Number of Participants With Detected Viremia
Time frame: Days 2, 4-16, 28
Microneutrilization (50%) Geometric Mean Titer
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42956783Chua JV, Price A, Sharaf S, Camacho Ortega S, Bernal PJ, Butler L, Koudjra AR, Joshi S, Hardy CSC, Currier JR, Waickman AT, Cairo C, Friberg H, Edelman R, Lyke KE. Novel dengue serotype 4 live virus human challenge: a phase 1 dose optimisation and homologous rechallenge study. Lancet Microbe. 2026 Oct 29:101542. doi: 10.1016/j.lanmic.2026.101542. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose and Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - Homologous Rechallenge in people with Dengue, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Injection Site Adverse Events (time frame: Days 1-7 post-challenge). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05268302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.