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

NCT00712803 | Completed Phase 1 DMC

• 1 other identifier: CIR 252
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Dengue

Outcome Measures

Primary Outcomes (2)

• Safety and immunogenicity, as assessed by neutralizing antibody titers

  At 4 weeks and 6 weeks after vaccination

• Frequency of vaccine related adverse events as graded by severity

  Throughout study

Secondary Outcomes (5)

• Frequency, quantity, and duration of viremia after a single dose of vaccine

  Throughout study

• Number of vaccines infected with rDEN3-3'D4delta30

  Throughout study

• Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine

  Throughout study

• Durability of antibody response

  At 26 Weeks after vaccination

• Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

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

Biological: rDEN3-3'D4delta30

2

EXPERIMENTAL

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.

Biological: rDEN3-3'D4delta30

Interventions

rDEN3-3'D4delta30 BIOLOGICAL

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

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Center for Immunization Research, Johns Hopkins School of Public Health

Washington D.C., District of Columbia, 20037, United States

Location

Center for Immunization Research, Johns Hopkins University of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• 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.

  PMID: 15642976 BACKGROUND

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

  PMID: 15937367 BACKGROUND

• 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.

  PMID: 15566333 BACKGROUND

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Anna Durbin, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (2)