Dengue Vaccine for Dengue Fever

Overseen By Camila D Odio, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressants, Cytotoxic, Blood products, others

Disqualifiers: HIV, Hepatitis B/C, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, only one vaccine is licensed for dengue, but it only protects people who have had dengue before. In people who have never had dengue, that vaccine increases the risk of severe disease. Better vaccines are needed. Objectives: To test a potential new vaccine against dengue. To see if side effects and immune responses are different depending on a person s previous exposure to dengue. Eligibility: Healthy people aged 18 to 59 years. Design: Participants will visit the clinic 11 times in 7 months; 9 of those visits will be in the first 2 months. Two additional visits are optional. Participants will be screened. They will have a physical exam with urine and blood tests. They will complete a survey about their travel history. Participants may opt to have a lymph node aspiration before receiving the study vaccine. An area in the left armpit will be numbed. A needle will be inserted to remove some cells from a lymph node. The vaccine will be injected into the fat under the skin of the participant s upper left arm. Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks. Then they will return for a provider visit and blood draws after longer intervals up to 7 months. The lymph node aspiration may be repeated at later visits. Participants may opt to return for a last visit after 12 months.

Research Team

Camila D Odio, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Healthy adults aged 18 to 59 can join this trial. They must not have had certain vaccines recently, avoid travel to dengue areas, and use effective contraception if they can get pregnant. Excluded are those with severe allergies, uncontrolled health conditions like asthma or diabetes, drug abuse issues, or a history of serious vaccine reactions.

Inclusion Criteria

In good general health as evidenced by medical history, physical examination, and laboratory screening results

For individuals who can become pregnant: use of at least one method of highly effective contraception from the invitation to participate in the trial through day 60 after vaccination

I have never been vaccinated or sick with flavivirus, nor traveled to areas where it's common.

Exclusion Criteria

Idiopathic urticaria within the past year

I have received blood products within the last 4 months.

My diabetes is not well controlled (A1c > 8).

Treatment Details

Interventions

• rDENdelta30/31-7164

Trial Overview The trial is testing a new dengue vaccine called rDENdelta30/31-7164. Participants will visit the clinic multiple times over seven months for injections into their upper arm fat and follow-up blood tests. Some may choose to have lymph node aspirations before and after vaccination.

Participant Groups

Group I: Primary Heterotypic DENV Antibody Profile Experimental Treatment 1 Intervention

Those who have a \>=70% neutralization or plaques at a 1:40 dilution for a single serotype, either DENV1, DENV2, or DENV4.

Group II: Polytypic DENV Antibody Profile Experimental Treatment 1 Intervention

Those considered immune (a \>=70% neutralization or plaques at a 1:40 dilution) to at least two serotypes.

Group III: Flavivirus Naive Experimental Treatment 1 Intervention

Those with \<=50% neutralization at a 1:10 dilution to all four DENV serotypes, no history of flavivirus vaccination, or travel history that increases the likelihood of other flavivirus infections.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+