Dengue
Conditions
Brief 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). 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.
Interventions
BIOLOGICALDengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose
Low dose 0.5 mL of the challenge strain is administered subcutaneously in the triceps region of the arm on Study Day 0.
BIOLOGICALDengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose - 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.
Sponsors
Medical Technology Enterprise Consortium (MTEC)
University of Maryland, Baltimore
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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: * 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
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fever | 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 |
| Number of Participants With Short-Term SAEs | 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 | Days 2, 4-16, 28, 180 | Number of SAEs until 6 months post virus inoculation |
| Number of Participants With Solicited Injection Site Adverse Events | 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 | 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 | 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 | 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 | 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 | Days 2, 4-16, 28 | unsolicited systemic adverse events until 28 days post virus inoculation or 7 days post hospitalization, whichever is later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microneutrilization (50%) Geometric Mean Titer | Day 28 | Microneutrilization (50%) Geometric Mean Titer Dengue antibodies |
| Number of Participants With Detected Viremia | Days 2, 4-16, 28 | 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?) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Main/Low Dose DHIM-4 Received 95 pfu DENV-4, primary | 14 |
| Homologous Rechallenge Received 95 pfu DENV-4, secondary | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
Baseline characteristics
| Characteristic | Main/Low Dose DHIM-4 | Homologous Rechallenge | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 20 Participants |
| Age, Continuous | 33.6 years | 32.5 years | 33 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 5 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 14 participants | 6 participants | 20 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 1 / 6 |
| other Total, other adverse events | 14 / 14 | 4 / 6 |
| serious Total, serious adverse events | 0 / 14 | 1 / 6 |
Outcome results
Primary
Incidence of Abnormal Laboratory Measurements
Incidence of abnormal laboratory measurements until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Low hemoglobin | 4 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Leukopenia | 4 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Increased ALT (Alanine Aminotransferase) | 3 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Neutropenia | 5 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Increased AST (Aspartate Aminotransferase) | 9 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Low fibrinogen | 2 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | High glucose | 1 Participants |
| Main/Low Dose DHIM-4 | Incidence of Abnormal Laboratory Measurements | Low glucose | 1 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | High glucose | 0 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Low hemoglobin | 4 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Increased AST (Aspartate Aminotransferase) | 2 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Increased ALT (Alanine Aminotransferase) | 2 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Low fibrinogen | 1 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Leukopenia | 0 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Neutropenia | 3 Participants |
| Homologous Rechallenge | Incidence of Abnormal Laboratory Measurements | Low glucose | 0 Participants |
Primary
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
Time frame: Days 2, 4-16, 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Muscle Pain | 9 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Nausea/Vomiting | 6 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Abdominal Pain | 3 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Rash | 14 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Joint/Bone Pain | 9 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Leukopenia | 4 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Headache/Eye Pain | 10 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Liver Function Abnormality | 9 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Fatigue | 14 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Thrombocytopenia | 0 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Dengue-Related Adverse Events | Fever | 3 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Thrombocytopenia | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Fever | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Headache/Eye Pain | 2 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Abdominal Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Muscle Pain | 1 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Joint/Bone Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Fatigue | 2 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Nausea/Vomiting | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Rash | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Leukopenia | 0 Participants |
| Homologous Rechallenge | Number of Participants With Dengue-Related Adverse Events | Liver Function Abnormality | 2 Participants |
Primary
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
Time frame: Days 2, 4-16, 28, 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Fever | 3 Participants |
| Homologous Rechallenge | Number of Participants With Fever | 0 Participants |
Primary
Number of Participants With Long-Term SAEs
Number of SAEs until 6 months post virus inoculation
Time frame: Days 2, 4-16, 28, 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Long-Term SAEs | 0 Participants |
| Homologous Rechallenge | Number of Participants With Long-Term SAEs | 1 Participants |
Primary
Number of Participants With Short-Term SAEs
Number of SAEs until 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Time frame: Days 2, 4-16, 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Short-Term SAEs | 0 Participants |
| Homologous Rechallenge | Number of Participants With Short-Term SAEs | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Adverse Events
solicited injection site adverse events until 7 days post virus inoculation
Time frame: Days 1-7 post-challenge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Injection Site Adverse Events | 1 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Injection Site Adverse Events | 0 Participants |
Primary
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
Time frame: Days 2, 4-16, 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Fever | 3 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Headache/Eye Pain | 10 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Abdominal Pain | 3 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Muscle Pain | 9 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Joint or Bone Pain | 9 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Fatigue | 14 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Nausea/Vomiting | 6 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Solicited Systemic Adverse Events | Rash | 14 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Rash | 0 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Fever | 0 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Joint or Bone Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Headache/Eye Pain | 2 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Nausea/Vomiting | 0 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Abdominal Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Fatigue | 2 Participants |
| Homologous Rechallenge | Number of Participants With Solicited Systemic Adverse Events | Muscle Pain | 1 Participants |
Primary
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
Time frame: Days 2, 4-16, 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Injection Site Adverse Events | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Injection Site Adverse Events | 0 Participants |
Primary
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
Time frame: Days 2, 4-16, 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Oropharyngeal Pain | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Bradycardia | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Tachycardia | 4 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Hypertension | 2 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | COVID-19 Infection | 3 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Nasopharyngitis | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Pruritis | 2 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Sensitive Skin | 2 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Chills | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Feeling Abnormal | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Pain | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Dyspnea | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Nasal Congestion | 1 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Decreased Appetite | 2 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Food Poisoning | 0 Participants |
| Main/Low Dose DHIM-4 | Number of Participants With Unsolicited Systemic Adverse Events | Craniocerebral Injury | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Craniocerebral Injury | 1 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Oropharyngeal Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Chills | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Bradycardia | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Nasal Congestion | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Tachycardia | 2 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Feeling Abnormal | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Hypertension | 2 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Food Poisoning | 1 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | COVID-19 Infection | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Pain | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Nasopharyngitis | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Decreased Appetite | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Pruritis | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Dyspnea | 0 Participants |
| Homologous Rechallenge | Number of Participants With Unsolicited Systemic Adverse Events | Sensitive Skin | 0 Participants |
Secondary
Microneutrilization (50%) Geometric Mean Titer
Microneutrilization (50%) Geometric Mean Titer Dengue antibodies
Time frame: Day 28
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Main/Low Dose DHIM-4 | Microneutrilization (50%) Geometric Mean Titer | 539.52 titer |
| Homologous Rechallenge | Microneutrilization (50%) Geometric Mean Titer | 903.69 titer |
Secondary
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?)
Time frame: Days 2, 4-16, 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main/Low Dose DHIM-4 | Number of Participants With Detected Viremia | 14 participants with detected viremia |
| Homologous Rechallenge | Number of Participants With Detected Viremia | 0 participants with detected viremia |