Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 1

Conditions

Dengue Fever

Treatments

Biological: Placebo

Biological: rDEN2/4delta30(ME) vaccine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00920517

CIR 250

Details and patient eligibility

About

Dengue fever, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.

Full description

Dengue viruses, which cause dengue fever and dengue shock syndrome, are a major cause of morbidity and mortality in several of the world's tropical and subtropical regions. The rDEN2/4delta30(ME) vaccine is a live attenuated dengue virus vaccine that may be protective against dengue virus serotype 2 (DEN2). The purpose of this study is to evaluate the safety and immunogenicity of the rDEN2/4delta30(ME) vaccine in healthy adults.

This study will last approximately 5 to 7 months with 25 study visits. Participants will be randomly assigned into one of two cohorts. Participants in Cohort 1 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 180. Participants in Cohort 2 will receive an injection of rDEN2/4delta30(ME) or placebo vaccine at Days 0 and 120. Participants will be asked to record their temperature in a diary for 16 days after each vaccination. At each study visit a physical examination, symptom history, and blood and urine collection will occur.

Enrollment

25 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Good general health as determined by means of the screening procedures.
Available for the duration of the study (32 weeks for cohort 1 and 23 weeks for cohort 2)
Willing to use effective methods of contraception

Exclusion criteria

Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator will affect the ability of the volunteer to understand and cooperate with the requirements of the study protocol
Neutropenia as defined by an ANC ≤1500/mm3
ALT level above the laboratory-defined upper limit of normal
Serum creatinine level above the laboratory-defined upper limit of normal
Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
History of a severe allergic reaction or anaphylaxis
Severe asthma (emergency room visit or hospitalization within the last 6 months)
Positive HIV-1 serology by screening and confirmatory assays
Positive for hepatitis C virus (HCV) by screening and confirmatory assays
Positive hepatitis B surface antigen (HBsAg) by enzyme-linked immunosorbent assay (ELISA)
Known immunodeficiency syndrome
Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study
Receipt of a live vaccine within the 4 weeks or a killed vaccine within the 2 weeks prior to entry into the study
Has had spleen surgically removed
Receipt of blood products within the 6 months prior to study entry
History or serologic evidence of previous dengue virus infection or other flavivirus infection (e.g. yellow fever virus, St. Louis encephalitis, West Nile virus).
Previous receipt of yellow fever or dengue vaccine (licensed or experimental)
Persons who have received any investigational agent in the 30 days prior to study entry
Persons who have definite plans to travel to a dengue endemic area during the study