Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-200,201) in Healthy Adults

NCT00270699 | Completed Phase 1 DMC

• 2 other identifiers: CIR 214WIRB Protocol Number 2006478
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue Fever

Keywords

Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome

Outcome Measures

Primary Outcomes (2)

• Frequency of vaccine-related adverse events, as classified by intensity and severity through active and passive surveillance and separate assessments of systemic and local reactions

  Throughout study

• Determine the number of vaccinees who have seroconverted to DEN4 up to and including Day 42

  At 42 days

Secondary Outcomes (7)

• Durability of antibody responses to DEN4 virus

  At 180 days

• Frequency, quantity, and duration of viremia in each dose cohort

  Thoughout study

• Number of vaccinees infected with vaccine virus in each dose cohort

  Throughout study

• Duration of antibody response determined by serum neutralizing antibody

  At 180 days

• Determine cellular targets of vaccine infection in participants willing to undergo skin biopsy

  Throughout study

Study Arms (4)

1

EXPERIMENTAL

One subcutaneous vaccination with rDEN4delta30-200,201 vaccine (10\^5 PFU dose) into the deltoid region of either arm.

Biological: rDEN4delta30-200,201

2

EXPERIMENTAL

One subcutaneous vaccination with rDEN4delta30-200,201 vaccine (10\^3 PFU dose) into the deltoid region of either arm. This arm will enroll after Arm 1.

Biological: rDEN4delta30-200,201

3

EXPERIMENTAL

One subcutaneous vaccination with rDEN4delta30-200,201 vaccine (10\^1 PFU dose) into the deltoid region of either arm. This arm will enroll after Arms 1 and 2.

Biological: rDEN4delta30-200,201

4

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

rDEN4delta30-200,201 BIOLOGICAL

Live attenuated dengue 4 vaccine (one of three doses)

1; 2; 3

Placebo BIOLOGICAL

Placebo for rDEN4delta30-200,201

4

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may affect the ability of the volunteer to understand and cooperate with the study
• Laboratory abnormalities at study screening
• Alcohol or drug abuse within 12 months prior to study entry
• History of severe allergic reaction or anaphylaxis
• Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
• HIV-1 infected
• Hepatitis C virus infected
• Hepatitis B surface antigen positive
• Known immunodeficiency syndrome
• Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
• Live vaccine within 4 weeks prior to study entry
• Killed vaccine within 2 weeks prior to study entry
• Blood products within 6 months prior to study entry
• Previously received a licensed or experimental yellow fever or dengue vaccine

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

• Durbin AP, Whitehead SS, McArthur J, Perreault JR, Blaney JE Jr, Thumar B, Murphy BR, Karron RA. rDEN4delta30, a live attenuated dengue virus type 4 vaccine candidate, is safe, immunogenic, and highly infectious in healthy adult volunteers. J Infect Dis. 2005 Mar 1;191(5):710-8. doi: 10.1086/427780. Epub 2005 Jan 27.

  PMID: 15688284 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

• Malavige GN, Fernando S, Fernando DJ, Seneviratne SL. Dengue viral infections. Postgrad Med J. 2004 Oct;80(948):588-601. doi: 10.1136/pgmj.2004.019638.

  PMID: 15466994 BACKGROUND

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

  PMID: 15057297 BACKGROUND

• 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.

  PMID: 14740952 BACKGROUND

MeSH Terms

Conditions

Dengue; Severe 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, Johns Hopkins School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 28, 2005
• Study Start: June 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (1)