DenguePhase 1NCT05967455
Homologous Re-infection With Dengue 1 or Dengue 3
A Phase 1 study testing Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC) and Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC) in people with Dengue, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Previous studies with one dengue infection in a controlled environment at Upstate generated data that has been important in understanding the clinical signs and symptoms and how a person's body reacts to dengue infection over time. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC) and Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 26 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 at the time of consent
- Ability and willingness to sign informed consent
- Passing score on comprehension test of at least 75%, with up to 3 attempts
- Available for the study period
- Willing to use contraception for the duration of the study (birth control pills or patches, intrauterine device (IUD), Depo-Provera, implantable birth control (implants of levonorgestrel), estrogenic vaginal ring, tubal ligation, vasectomy of the sole male partner, male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository), male condom combined with a female diaphragm, either with or without vaginal spermicide, partner in a homosexual relationship, abstinence)
- Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit
Who cannot join
- Female: pregnant or lactating
- Heavy menstrual bleeding within the last 6 months- menstrual periods lasting longer than 6 days or requiring 5 or more pads or tampons per day, endometriosis or uterine scarring
- Women who intend to become pregnant or men who intend to father a child during the study period (approximately 209 days for Cohorts 1 and 2 and approximately 91 days for Cohorts 3 and 4)
- Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus
- Positive antibodies to dengue (cohorts 1 and 2). If the subject has previously screened negative for dengue in the last 12 months and has not traveled to an endemic area. The results of the previous screening will be used.
- Any history of dengue infection or dengue vaccination (licensed or experimental) (cohorts 1 and 2); or planned dengue vaccination during the study period (all cohorts)
Show all 27Show fewer
- Recent (in the past 4 weeks) travel to any dengue endemic area or travel to a country with risk of yellow fever or Japanese encephalitis transmission
- Positive urine screen for cocaine, amphetamines, opiates or methadone
- Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
- Active diabetes, active peptic ulcer disease (PUD), chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD)
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Current, or a history of, auto-immune disease other than well controlled Hashimoto's thyroiditis
- History of Guillain-Barré syndrome (GBS)
- Diagnosis with Bipolar Disorder or 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 subject from participating in the study.
- Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish allergy, fetal bovine serum, L-glutamine, neomycin and streptomycin
- Chronic migraine headaches, defined as more than 15 headache days per month over a 3 month period of which more than 8 are migraines, in the absence of medication over use
- Planning to donate blood in the 1 year following inoculation with dengue
- Recent blood donation within prior 14 days of inoculation
- Receipt of blood products or antibodies within 56 days of inoculation or during the study period
- Planned travel during the study period (approximately 210 days for Cohorts 1 and 2 and approximately 91 days for Cohorts 3 and 4) which would interfere with the ability to complete all study visits
- Subjects with the following grade 2 or greater lab abnormalities: Creatinine; ALT, AST; Hemoglobin (females and males); WBC; Platelets; PT; PTT; Fibrinogen
- Any laboratory abnormalities prior to inoculation that are considered by the investigator to be clinically significant in addition those listed above
- Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety
- Participation (active or follow-up phase) or planned participation in another vaccine, drug, or medical device in the 4 weeks prior to this trial or during the trial
- Recent or scheduled receipt of any vaccine 4 weeks prior to or after virus inoculation
- Beliefs that bar the administration of blood products or transfusions
- Clinician discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, 13210
About this study
Official title: Phase One, Open Label, Homologous Reinfection With Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) or Dengue-3-Virus-Live Virus Human Challenge (DENV-3-LVHC) Virus Strains
Previous studies with one dengue infection in a controlled environment at Upstate generated data that has been important in understanding the clinical signs and symptoms and how a person's body reacts to dengue infection over time. This has helped investigators compare what is seen in the clinic to what is seen in areas where dengue is prevalent. The investigators want to collect similar information when a person gets the same dengue twice in a controlled environment with the hope that this will lead them to a better understanding of the disease.
New participants
Read more
- will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
- will receive a second inoculation after 6 months and return to the clinic or be contacted by phone for three more months;
- will collect saliva at home;
- will allow the study team to collect blood and saliva at the clinic visits.
Participants who have been in previous dengue inoculation studies at SUNY Upstate
- will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
- will collect saliva at home;
- will allow the study team to collect blood and saliva at the clinic visits.
All participants will be seen in the clinic every other day for the first three weeks after any inoculation.
Read the detailed description
The purpose of this study is to explore the clinical, virologic, and immunologic response of subjects following primary controlled dengue infection or following controlled homologous dengue reinfection.
SUNY Upstate Medical University completed three Dengue Human Infection Model studies, two with dengue 1 (DENV-1-LVHC), NCT 02372175 and NCT 03869060, and one with dengue 3 (DENV-3-LVHC), NCT 04298138 and investigators gained incredible knowledge about primary dengue infection. The investigators are moving to the next step in acquiring knowledge about the kinetics of homologous secondary infection in a controlled setting in this study. People who acquire natural dengue infection and who are subsequently infected by the same serotype are thought to have lifelong protection to that serotype.
Investigators will recruit up to 10 naive participants and infect them with either DENV-1-LVHC or DENV-3-LVHC with the same dose of virus as in previous studies. These participants will be followed over 6 months and reinfected with the same serotype originally received, i.e. homologous reinfection, and followed for another three months. Investigators will also recruit up to 10 participants who received either DENV-1-LVHC or DENV-3-LVHC in previous studies. These participants will be reinfected with the same serotype that was previously received and followed for 6 months. Investigators intend to collect similar information about the kinetics of homologous secondary infection as was collected in the studies following primary infection.
- Conditions
- Dengue
- Being tested
- Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC), Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)
- Keywords
- Dengue, Flavivirus Infections, Virus Diseases
- Medical subject headings
- Dengue, Flavivirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC)Biological
Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5
Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)Biological
Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Naive DENV1 | Experimental | Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), two doses (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181. Receives: Biological: Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC) |
| Cohort 2 Naive DENV3 | Experimental | Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), two doses (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181. Receives: Biological: Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC) |
| Cohort 3 Returning DENV1 | Experimental | Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), single dose (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1. Receives: Biological: Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC) |
| Cohort 4 Returning DENV3 | Experimental | Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), single dose (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1. Receives: Biological: Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Solicited Injection Site Symptoms
Number of solicited symptoms
Measured: 6 days post virus inoculation
Intensity of Solicited Injection Site Symptoms
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Measured: 6 days post virus inoculation
Duration of Solicited Injection Site Symptoms
Number of days per symptom
Measured: 6 days post virus inoculation
Occurrence of Solicited Systemic Symptoms
Number of solicited symptoms
Measured: 20 day post primary infection for cohorts 1 and 2 and 20 days post reinfection, all cohorts
Intensity of Solicited Systemic Symptoms
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Measured: 20 day post primary infection, cohorts 1 and 2 and 20 days post reinfection, all cohorts
Duration of Solicited Systemic Symptoms
Number of days per symptom
Measured: 20 day post primary infection, cohorts 1 and 2 and 20 days post reinfection, all cohorts
Occurrence of Unsolicited Systemic Symptoms
Number of unsolicited symptom
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Intensity of Unsolicited Systemic Symptoms
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Duration of Unsolicited Systemic Symptoms
Number of days per symptom
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Number of Abnormal Laboratory Measurements
Total number of all abnormal labs
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Intensity of Abnormal Laboratory Measurements
Graded according to SUNY Upstate clinical laboratory normals and FDA Tables for Laboratory Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Duration of Abnormal Laboratory Measurements
Number of days of abnormal labs
Measured: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Number of Serious Adverse Events
Total number
Measured: 6 months post primary infection, cohorts 1 and 2
Number of Serious Adverse Events
Total number
Measured: 3 months post reinfection, cohorts 1 and 2
Number of Serious Adverse Events
Total number
Measured: 6 months post reinfection, cohorts 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start30 Oct 2023
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Stephen J Thomas, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967455
- Sponsor's protocol ID
- 2023-01-UMU
- Status last verified
- Oct 2024
- First submitted
- 21 Jul 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Endy TP, Wang D, Polhemus ME, Jarman RG, Jasper LE, Gromowski G, Lin L, De La Barra RA, Friberg H, Currier JR, Abbott M, Ware L, Klick M, Paolino KM, Blair DC, Eckels K, Rutvisuttinunt W, Thomas SJ. A Phase 1, Open-Label Assessment of a Dengue Virus-1 Live Virus Human Challenge Strain. J Infect Dis. 2021 Feb 3;223(2):258-267. doi: 10.1093/infdis/jiaa351.
PubMed 32572470Waickman AT, Lu JQ, Fang H, Waldran MJ, Gebo C, Currier JR, Ware L, Van Wesenbeeck L, Verpoorten N, Lenz O, Tambuyzer L, Herrera-Taracena G, Van Loock M, Endy TP, Thomas SJ. Evolution of inflammation and immunity in a dengue virus 1 human infection model. Sci Transl Med. 2022 Oct 26;14(668):eabo5019. doi: 10.1126/scitranslmed.abo5019. Epub 2022 Oct 26.
PubMed 36288280
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase One, Open Label, Homologous Reinfection With Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) or Dengue-3-Virus-Live Virus Human Challenge (DENV-3-LVHC) Virus Strains
- ClinicalTrials.gov ID
- NCT05967455
- Acronym / sponsor ID
- 2023-01-UMU
- Conditions
- Dengue
- Keywords
- Dengue, Flavivirus Infections, Virus Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, Walter Reed Army Institute of Research (WRAIR)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies with one dengue infection in a controlled environment at Upstate generated data that has been important in understanding the clinical signs and symptoms and how a person's body reacts to dengue infection over time. This has helped investigators compare what is seen in the clinic to what is seen in areas where dengue is prevalent. The investigators want to collect similar information when a person gets the same dengue twice in a controlled environment with the hope that this will lead them to a better understanding of the disease.
New participants
- will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
- will receive a second inoculation after 6 months and return to the clinic or be contacted by phone for three more months;
- will collect saliva at home;
- will allow the study team to collect blood and saliva at the clinic visits.
Participants who have been in previous dengue inoculation studies at SUNY Upstate
- will receive one inoculation of dengue and then return to the clinic or be contacted by phone over 6 months;
- will collect saliva at home;
- will allow the study team to collect blood and saliva at the clinic visits.
All participants will be seen in the clinic every other day for the first three weeks after any inoculation.
Detailed description
The purpose of this study is to explore the clinical, virologic, and immunologic response of subjects following primary controlled dengue infection or following controlled homologous dengue reinfection.
SUNY Upstate Medical University completed three Dengue Human Infection Model studies, two with dengue 1 (DENV-1-LVHC), NCT 02372175 and NCT 03869060, and one with dengue 3 (DENV-3-LVHC), NCT 04298138 and investigators gained incredible knowledge about primary dengue infection. The investigators are moving to the next step in acquiring knowledge about the kinetics of homologous secondary infection in a controlled setting in this study. People who acquire natural dengue infection and who are subsequently infected by the same serotype are thought to have lifelong protection to that serotype.
Investigators will recruit up to 10 naive participants and infect them with either DENV-1-LVHC or DENV-3-LVHC with the same dose of virus as in previous studies. These participants will be followed over 6 months and reinfected with the same serotype originally received, i.e. homologous reinfection, and followed for another three months. Investigators will also recruit up to 10 participants who received either DENV-1-LVHC or DENV-3-LVHC in previous studies. These participants will be reinfected with the same serotype that was previously received and followed for 6 months. Investigators intend to collect similar information about the kinetics of homologous secondary infection as was collected in the studies following primary infection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Naive DENV1 | Experimental | Biological: Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC)Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), two doses (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181. |
| Cohort 2 Naive DENV3 | Experimental | Biological: Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), two doses (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181. |
| Cohort 3 Returning DENV1 | Experimental | Biological: Dengue virus 1 Live Virus Human Challenge (DENV-1-LVHC)Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), single dose (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1. |
| Cohort 4 Returning DENV3 | Experimental | Biological: Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), single dose (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-55 at the time of consent
- Ability and willingness to sign informed consent
- Passing score on comprehension test of at least 75%, with up to 3 attempts
- Available for the study period
- Willing to use contraception for the duration of the study (birth control pills or patches, intrauterine device (IUD), Depo-Provera, implantable birth control (implants of levonorgestrel), estrogenic vaginal ring, tubal ligation, vasectomy of the sole male partner, male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository), male condom combined with a female diaphragm, either with or without vaginal spermicide, partner in a homosexual relationship, abstinence)
Key exclusion criteria (27 listed)
- Female: pregnant or lactating
- Heavy menstrual bleeding within the last 6 months- menstrual periods lasting longer than 6 days or requiring 5 or more pads or tampons per day, endometriosis or uterine scarring
- Women who intend to become pregnant or men who intend to father a child during the study period (approximately 209 days for Cohorts 1 and 2 and approximately 91 days for Cohorts 3 and 4)
- Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus
- Positive antibodies to dengue (cohorts 1 and 2). If the subject has previously screened negative for dengue in the last 12 months and has not traveled to an endemic area. The results of the previous screening will be used.
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 virus 1 Live Virus Human Challenge (DENV-1-LVHC)Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 | Biological | Cohort 1 Naive DENV1, Cohort 3 Returning DENV1 |
| Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 | Biological | Cohort 2 Naive DENV3, Cohort 4 Returning DENV3 |
Primary outcome
Occurrence of Solicited Injection Site Symptoms
Time frame: 6 days post virus inoculation
Number of solicited symptoms
Intensity of Solicited Injection Site Symptoms
Time frame: 6 days post virus inoculation
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Duration of Solicited Injection Site Symptoms
Time frame: 6 days post virus inoculation
Number of days per symptom
Occurrence of Solicited Systemic Symptoms
Time frame: 20 day post primary infection for cohorts 1 and 2 and 20 days post reinfection, all cohorts
Number of solicited symptoms
Intensity of Solicited Systemic Symptoms
Time frame: 20 day post primary infection, cohorts 1 and 2 and 20 days post reinfection, all cohorts
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Duration of Solicited Systemic Symptoms
Time frame: 20 day post primary infection, cohorts 1 and 2 and 20 days post reinfection, all cohorts
Number of days per symptom
Occurrence of Unsolicited Systemic Symptoms
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Number of unsolicited symptom
Intensity of Unsolicited Systemic Symptoms
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Graded according to FDA Tables for Clinical Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Duration of Unsolicited Systemic Symptoms
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Number of days per symptom
Number of Abnormal Laboratory Measurements
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Total number of all abnormal labs
Intensity of Abnormal Laboratory Measurements
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Graded according to SUNY Upstate clinical laboratory normals and FDA Tables for Laboratory Abnormalities: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), Grade 4 (Potentially life threatening)
Duration of Abnormal Laboratory Measurements
Time frame: 28 day post primary infection, cohorts 1 and 2 and 28 days post reinfection, all cohorts
Number of days of abnormal labs
Number of Serious Adverse Events
Time frame: 6 months post primary infection, cohorts 1 and 2
Total number
Number of Serious Adverse Events
Time frame: 3 months post reinfection, cohorts 1 and 2
Total number
Number of Serious Adverse Events
Time frame: 6 months post reinfection, cohorts 3 and 4
Total number
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Results publication: PubMed 32572470Endy TP, Wang D, Polhemus ME, Jarman RG, Jasper LE, Gromowski G, Lin L, De La Barra RA, Friberg H, Currier JR, Abbott M, Ware L, Klick M, Paolino KM, Blair DC, Eckels K, Rutvisuttinunt W, Thomas SJ. A Phase 1, Open-Label Assessment of a Dengue Virus-1 Live Virus Human Challenge Strain. J Infect Dis. 2021 Feb 3;223(2):258-267. doi: 10.1093/infdis/jiaa351.
- Results publication: PubMed 36288280Waickman AT, Lu JQ, Fang H, Waldran MJ, Gebo C, Currier JR, Ware L, Van Wesenbeeck L, Verpoorten N, Lenz O, Tambuyzer L, Herrera-Taracena G, Van Loock M, Endy TP, Thomas SJ. Evolution of inflammation and immunity in a dengue virus 1 human infection model. Sci Transl Med. 2022 Oct 26;14(668):eabo5019. doi: 10.1126/scitranslmed.abo5019. Epub 2022 Oct 26.
- Individual participant dataSharing planned: No
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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.
Stephen J Thomas, MD principal investigator
State University of New York - Upstate Medical University
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 virus 1 Live Virus Human Challenge (DENV-1-LVHC) and Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC) in people with Dengue, run by State University of New York - Upstate Medical University 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 6 inclusion and 27 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 13 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of Solicited Injection Site Symptoms (time frame: 6 days post virus inoculation). The study lists 15 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 NCT05967455, which also lists 2 linked publications.
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 13 Nov 2024.