Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

NCT ID: NCT00089908

Last Updated: 2008-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-11-30

Brief Summary

Dengue fever, which is caused by dengue viruses, is a major health problem in 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

More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.

This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.

After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.

Conditions

Dengue Fever

Study Design

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

Study Groups

1

One subcutaneous vaccination with rDEN1delta30 vaccine (10\^3 PFU dose) into the deltoid region of either arm.

Group Type: EXPERIMENTAL

rDEN1delta30

Intervention Type: BIOLOGICAL

Live attenuated rDEN1delta30 vaccine

2

One subcutaneous vaccination with rDEN1delta30 vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.

Group Type: EXPERIMENTAL

rDEN1delta30

Intervention Type: BIOLOGICAL

Live attenuated rDEN1delta30 vaccine

3

One subcutaneous vaccination with placebo into the deltoid region of either arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo for rDEN1delta30

Interventions

rDEN1delta30

Live attenuated rDEN1delta30 vaccine

Intervention Type: BIOLOGICAL

Placebo

Placebo for rDEN1delta30

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Willing to be followed for the duration of the study
• Willing to use acceptable methods of contraception
• Good general health

Exclusion Criteria

• Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
• Liver, renal, or hematologic disease
• Alcohol or drug abuse within 12 months of study entry
• History of severe allergic reaction or anaphylaxis
• Emergency room visit or hospitalization for severe asthma within 6 months of study entry
• HIV-1 infected
• HCV infected
• Hepatitis B surface antigen positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
• Live vaccine within 4 weeks of study entry
• Killed vaccine within 2 weeks of study entry
• Blood products within 6 months of study entry
• Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
• Previously received a licensed or experimental yellow fever or dengue vaccine
• Surgical removal of spleen
• History of dengue virus infection or other flavivirus infection
• Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
• Pregnancy or breastfeeding
• Plan to travel to an area where dengue infection is common

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

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Center for Immunization Research, Johns Hopkins School of Public Health

Principal Investigators

Anna Durbin, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Immunization Research, John Hopkins School of Public Health

Locations

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, United States

Countries

United States

References

Jacobs M, Young P. Dengue vaccines: preparing to roll back dengue. Curr Opin Investig Drugs. 2003 Feb;4(2):168-71.

Reference Type: BACKGROUND

PMID: 12669377 (View on PubMed)

Pang T. Vaccines for the prevention of neglected diseases--dengue fever. Curr Opin Biotechnol. 2003 Jun;14(3):332-6. doi: 10.1016/s0958-1669(03)00061-2.

Reference Type: BACKGROUND

PMID: 12849789 (View on PubMed)

Rothman AL. Dengue: defining protective versus pathologic immunity. J Clin Invest. 2004 Apr;113(7):946-51. doi: 10.1172/JCI21512.

Reference Type: BACKGROUND

PMID: 15057297 (View on PubMed)

Sun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, Houng HS, Tang D, Scherer JM, Hoke CH Jr, Innis BL. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003 Dec;69(6 Suppl):24-31. doi: 10.4269/ajtmh.2003.69.6_suppl.0690024.

Reference Type: BACKGROUND

PMID: 14740952 (View on PubMed)

Other Identifiers

H.22.04.04.23.B2

Identifier Type: -

Identifier Source: secondary_id

CIR 199

Identifier Type: -

Identifier Source: org_study_id