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Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus

NCT ID: NCT00458120

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-31

Brief Summary

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Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.

Detailed Description

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The World Health Organization estimates that dengue virus causes more than 50 million cases of dengue fever a year. Dengue virus infection is the leading cause of hospitalization and death in children of most tropical Asian countries. There are four different serotypes of dengue virus. Most cases of dengue hemorrhagic fever/dengue shock syndrome are caused by secondary infection with a dengue serotype different from the first serotype the individual was infected with. A vaccine that would be effective in preventing infection by multiple dengue serotypes is desirable. The purpose of this study is to determine the safety of and immune response to two different dengue virus vaccines in individuals who have been previously vaccinated against a different serotype.

This study will last at least 42 days. Participants will be recruited from a database of previous dengue vaccine recipients and will be stratified by the type of vaccine previously received. Participants assigned to Cohort 1 and Cohort 2 will have already been vaccinated with the rDEN4delta30 vaccine. Participants assigned to Cohort 3 will have already been vaccinated with the rDEN2/4delta30(ME) vaccine. Participants in Cohort 4 will have already been vaccinated with the rDEN1delta30 vaccine. Participants in Cohorts 1 and 3 will be randomly assigned to receive either the rDEN1delta30 vaccine or placebo. Participants in Cohorts 2 and 4 will be randomly assigned to receive either the rDEN2/4delta30(ME) vaccine or placebo.

Participants will receive their assigned vaccination on Day 0. Study visits will occur every other day until Day 16, and then at Days 21, 28, and 42. At each visit, blood collection, vital signs measurement, and a physical exam will occur. In addition, participants will be asked to monitor their temperature daily, 3 times a day, from Day 0 to Day 16. Patients will also be asked to enroll in an optional skin biopsy sub-study.

Conditions

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Dengue Hemorrhagic Fever

Keywords

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Dengue Fever Dengue Hemorrhagic Fever Dengue Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.

Group Type EXPERIMENTAL

rDEN1delta30

Intervention Type BIOLOGICAL

Live attenuated 10\^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.

2

Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN2/4delta30(ME) into the deltoid region of either arm.

Group Type EXPERIMENTAL

rDEN2/4delta30(ME)

Intervention Type BIOLOGICAL

Live attenuated 10\^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.

3

Participants previously vaccinated with rDEN2/4delta30(ME) will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.

Group Type EXPERIMENTAL

rDEN1delta30

Intervention Type BIOLOGICAL

Live attenuated 10\^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.

4

Participants previously vaccinated with rDEN1delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN2/4delta30(ME) vaccine into the deltoid region of either arm.

Group Type EXPERIMENTAL

rDEN2/4delta30(ME)

Intervention Type BIOLOGICAL

Live attenuated 10\^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.

5

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

Group Type PLACEBO_COMPARATOR

Placebo to rDEN1delta30 or rDEN2/4delta30(ME)

Intervention Type BIOLOGICAL

Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)

Interventions

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rDEN1delta30

Live attenuated 10\^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.

Intervention Type BIOLOGICAL

rDEN2/4delta30(ME)

Live attenuated 10\^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.

Intervention Type BIOLOGICAL

Placebo to rDEN1delta30 or rDEN2/4delta30(ME)

Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine
* 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
* 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

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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

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Center for Immunization Research, Johns Hopkins School of Public Health

Principal Investigators

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Anna Durbin, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Immunization Research, Johns Hopkins School of Public Health

Locations

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Center for Immunization Research

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15688284 (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)

Durbin AP, Schmidt A, Elwood D, Wanionek KA, Lovchik J, Thumar B, Murphy BR, Whitehead SS. Heterotypic dengue infection with live attenuated monotypic dengue virus vaccines: implications for vaccination of populations in areas where dengue is endemic. J Infect Dis. 2011 Feb 1;203(3):327-34. doi: 10.1093/infdis/jiq059. Epub 2010 Dec 14.

Reference Type DERIVED
PMID: 21208923 (View on PubMed)

Other Identifiers

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WIRB Protocol Number 20070409

Identifier Type: -

Identifier Source: secondary_id

CIR 227

Identifier Type: -

Identifier Source: org_study_id