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Safety of and Immune Response to a Dengue Virus Vaccine (rDEN2/4delta30[ME]) in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00094705
Recruitment Status : Completed
First Posted : October 22, 2004
Last Update Posted : January 21, 2008
Sponsor:
Collaborator:
Johns Hopkins Bloomberg School of Public Health
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Dengue Fever Biological: rDEN2/4delta30(ME) Vaccine Biological: Placebo Phase 1

Detailed Description:

Dengue viruses cause dengue fever, as well as 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 rDEN2/4delta30(ME), which is derived from the DEN2 and DEN4 serotypes.

This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN2/4delta30(ME) 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 rDEN2/4delta30(ME) or placebo.

After vaccination, participants will be observed for at least 30 minutes for immediate adverse reactions. Participants will also 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase 1 Study of the Safety and Immunogenicity of rDEN2/4delta30(ME), a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 2
Study Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: 1
One subcutaneous vaccination with a 10^3 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
Biological: rDEN2/4delta30(ME) Vaccine
Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)

Experimental: 2
One subcutaneous vaccination with a 10^5 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.
Biological: rDEN2/4delta30(ME) Vaccine
Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)

Placebo Comparator: 3
One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm.
Biological: Placebo
Placebo for rDEN2/4delta30(ME) vaccine




Primary Outcome Measures :
  1. Frequency and severity of vaccine-related adverse effects for each dose graded by severity [ Time Frame: Throughout study ]
  2. Amount of dengue 2 neutralizing antibody induced by the vaccine [ Time Frame: At Day 42 ]

Secondary Outcome Measures :
  1. To assess the durability of the antibody response out to Day 180 [ Time Frame: Throughout study ]
  2. To assess the frequency, quantity, and duration of viremia in each dose cohort studied [ Time Frame: Throughout study ]
  3. To determine the number of vaccinees infected with rDEN2/4delta30(ME) [ Time Frame: Throughout study ]
  4. To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN2/4delta30(ME) vaccine virus with that of uninfected volunteers and placebo recipients [ Time Frame: Throughout study ]
  5. If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups [ Time Frame: At study completion ]
  6. To evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Hematologic disease
  • 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
  • Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while this trial is ongoing
  • Previously received a licensed or experimental yellow fever or dengue vaccine
  • Surgical removal of spleen
  • History of dengue virus infection or other flavivirus infection (e.g., yellow fever virus, St. Louis encephalitis, West Nile virus, Japanese encephalitis virus)
  • Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
  • Plan to travel to an area where dengue infection is common
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00094705


Locations
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United States, Maryland
Johns Hopkins School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Anna Durbin, MD Center for Immunization Research, Johns Hopkins School of Public Health

Publications:
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Responsible Party: Anna Durbin, MD, Center for Immunization Research, Johns Hopkins School of Public Health
ClinicalTrials.gov Identifier: NCT00094705     History of Changes
Other Study ID Numbers: CIR 189
H.22.03.09.26.A2
First Posted: October 22, 2004    Key Record Dates
Last Update Posted: January 21, 2008
Last Verified: January 2008

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Dengue Vaccine
Dengue Virus
Dengue Hemorrhagic Fever
Dengue Shock Syndrome

Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs