Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults

NCT ID: NCT00712803

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-09-30

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 evaluate the safety of and immune response to a new dengue virus vaccine in healthy adults.

Detailed Description

Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock syndrome. More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection, which 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 vaccine called rDEN3-3'D4delta30. This vaccine is derived from rDEN4delta30, another dengue virus vaccine candidate that has been shown to be safe and immunogenic in Phase I and II trials in healthy adults.

There will be two groups in this study. Participants in Group 1 will be randomly assigned to receive rDEN3-3'D4delta30 vaccine or placebo at study entry. The dosing for Group 2 will be determined by a safety review of all participants in Group 1. If less than 90 % of the Group 1 participants seroconvert to DEN3 participants in Group 2 will receive a higher dose of rDEN3-3'D4delta30. If at least 90 % of Group 1 participants seroconvert to DEN3, participants in Group 2 will receive a lower dose of rDEN3-3'D4delta30.

All participants will be required to monitor their temperature three times each day for the first 16 days following each vaccination. Study visits will occur 30 minutes following each vaccination and every other day after vaccination until Day 16, followed by four additional visits at selected days through Day 180. Blood collection, vital signs measurement, 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

Study Design

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

Study Groups

1

One subcutaneous vaccination (10\^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.

Group Type: EXPERIMENTAL

rDEN3-3'D4delta30

Intervention Type: BIOLOGICAL

Live attenuated 10\^3 dose of rDEN3-3'D4delta30 vaccine.

2

One subcutaneous vaccination (10\^5 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm OR one subcutaneous vaccination (10\^1 dose of vaccine or placebo) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm.

Group Type: EXPERIMENTAL

rDEN3-3'D4delta30

Intervention Type: BIOLOGICAL

Live attenuated 10\^5 dose of rDEN3-3'D4delta30 vaccine.

rDEN3-3'D4delta30

Intervention Type: BIOLOGICAL

Live attenuated 10\^1 dose of rDEN3-3'D4delta30 vaccine.

Interventions

rDEN3-3'D4delta30

Live attenuated 10\^3 dose of rDEN3-3'D4delta30 vaccine.

Intervention Type: BIOLOGICAL

rDEN3-3'D4delta30

Live attenuated 10\^5 dose of rDEN3-3'D4delta30 vaccine.

Intervention Type: BIOLOGICAL

rDEN3-3'D4delta30

Live attenuated 10\^1 dose of rDEN3-3'D4delta30 vaccine.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• General good health
• Available for the duration of the study
• Willing to use accepted forms of contraception

Exclusion Criteria

• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
• Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
• Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
• History of severe allergy or anaphylaxis
• Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
• HIV infected
• Hepatitis C virus infected
• Hepatitis B surface antibody positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
• Receipt of live vaccine within 4 weeks of study entry
• Receipt of killed vaccine within 2 weeks of study entry
• Absence of spleen
• Plan to travel to an area where dengue virus is common
• Any investigational product within 30 days of study entry
• Other condition that, in the opinion of the investigator, would interfere with the study
• Pregnancy or breastfeeding

• 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

Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Locations

Center for Immunization Research, Johns Hopkins School of Public Health

Washington D.C., District of Columbia, United States

Center for Immunization Research, Johns Hopkins University of Public Health

Baltimore, Maryland, United States

Countries

United States

References

Blaney JE Jr, Hanson CT, Firestone CY, Hanley KA, Murphy BR, Whitehead SS. Genetically modified, live attenuated dengue virus type 3 vaccine candidates. Am J Trop Med Hyg. 2004 Dec;71(6):811-21.

Reference Type: BACKGROUND

PMID: 15642976 (View on PubMed)

Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52.

Reference Type: BACKGROUND

PMID: 15937367 (View on PubMed)

Guzman MG, Mune M, Kouri G. Dengue vaccine: priorities and progress. Expert Rev Anti Infect Ther. 2004 Dec;2(6):895-911. doi: 10.1586/14789072.2.6.895.

Reference Type: BACKGROUND

PMID: 15566333 (View on PubMed)

Other Identifiers

CIR 252

Identifier Type: -

Identifier Source: org_study_id