Status:
COMPLETED
Homologous Re-infection With Dengue 1 or Dengue 3
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Dengue
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
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 reinfectio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05967455
Start Date
October 30 2023
End Date
August 26 2024
Last Update
November 13 2024
Active Locations (1)
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1
State University of New York, Upstate Medical University (SUNY-UMU)
Syracuse, New York, United States, 13210