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

NCT ID: NCT00920517

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

Brief Summary

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.

Detailed 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.

Conditions

Dengue Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Participants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 180

Group Type: ACTIVE_COMPARATOR

rDEN2/4delta30(ME) vaccine

Intervention Type: BIOLOGICAL

10\^3 PFU dose

Placebo

Intervention Type: BIOLOGICAL

placebo for rDEN2/4delta30(ME) vaccine

2

Participants will receive 1 injection of rDEN2/4delta30(ME) or placebo vaccine on Days 0 and 120

Group Type: ACTIVE_COMPARATOR

rDEN2/4delta30(ME) vaccine

Intervention Type: BIOLOGICAL

10\^3 PFU dose

Placebo

Intervention Type: BIOLOGICAL

placebo for rDEN2/4delta30(ME) vaccine

Interventions

rDEN2/4delta30(ME) vaccine

10\^3 PFU dose

Intervention Type: BIOLOGICAL

Placebo

placebo for rDEN2/4delta30(ME) vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Durbin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Center for Immunization Research

Baltimore, Maryland, United States

Countries

United States

References

Katzelnick LC, Fonville JM, Gromowski GD, Bustos Arriaga J, Green A, James SL, Lau L, Montoya M, Wang C, VanBlargan LA, Russell CA, Thu HM, Pierson TC, Buchy P, Aaskov JG, Munoz-Jordan JL, Vasilakis N, Gibbons RV, Tesh RB, Osterhaus AD, Fouchier RA, Durbin A, Simmons CP, Holmes EC, Harris E, Whitehead SS, Smith DJ. Dengue viruses cluster antigenically but not as discrete serotypes. Science. 2015 Sep 18;349(6254):1338-43. doi: 10.1126/science.aac5017.

Reference Type: DERIVED

PMID: 26383952 (View on PubMed)

Other Identifiers

CIR 250

Identifier Type: -

Identifier Source: org_study_id