DenguePhase 1NCT00712803
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
A Phase 1 study testing rDEN3-3'D4delta30 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- rDEN3-3'D4delta30
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General good health
- Available for the duration of the study
- Willing to use accepted forms of contraception
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research, Johns Hopkins University of Public Health
Baltimore, Maryland, 21205
Center for Immunization Research, Johns Hopkins School of Public Health
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3-3'Ddelta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
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.
Read the 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
- Being tested
- rDEN3-3'D4delta30
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rDEN3-3'D4delta30Biological
Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine.
rDEN3-3'D4delta30Biological
Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine.
rDEN3-3'D4delta30Biological
Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One subcutaneous vaccination (10^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm. Receives: 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. Receives: Biological: rDEN3-3'D4delta30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immunogenicity, as assessed by neutralizing antibody titers
Measured: At 4 weeks and 6 weeks after vaccination
Frequency of vaccine related adverse events as graded by severity
Measured: Throughout study
Secondary outcomes (5)
Frequency, quantity, and duration of viremia after a single dose of vaccine
Measured: Throughout study
Number of vaccines infected with rDEN3-3'D4delta30
Measured: Throughout study
Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine
Measured: Throughout study
Durability of antibody response
Measured: At 26 Weeks after vaccination
Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anna Durbin, MD, Principal investigator, Center for Immunization Research (CIR), Johns Hopkins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712803
- Sponsor's protocol ID
- CIR 252
- Status last verified
- Dec 2012
- First submitted
- 8 Jul 2008
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15642976Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52.
PubMed 15937367Guzman 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.
PubMed 15566333
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3-3'Ddelta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 3
- ClinicalTrials.gov ID
- NCT00712803
- Acronym / sponsor ID
- CIR 252
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rDEN3-3'D4delta30One subcutaneous vaccination (10^3 dose of vaccine) of rDEN3-3'D4delta30 vaccine into the deltoid region of either arm. |
| 2 | Experimental | Biological: rDEN3-3'D4delta30One 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- General good health
- Available for the duration of the study
- Willing to use accepted forms of contraception
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rDEN3-3'D4delta30Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine. | Biological | 1 |
| rDEN3-3'D4delta30Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine. | Biological | 2 |
| rDEN3-3'D4delta30Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine. | Biological | 2 |
Primary outcome
Safety and immunogenicity, as assessed by neutralizing antibody titers
Time frame: At 4 weeks and 6 weeks after vaccination
Frequency of vaccine related adverse events as graded by severity
Time frame: Throughout study
5 secondary outcomes
Frequency, quantity, and duration of viremia after a single dose of vaccine
Time frame: Throughout study
Number of vaccines infected with rDEN3-3'D4delta30
Time frame: Throughout study
Infectivity rates, safety, and immunogenicity of a single dose of rDEN3-3'D4delta30 vaccine
Time frame: Throughout study
Durability of antibody response
Time frame: At 26 Weeks after vaccination
Obtain an estimate for the Human Infectious Dose-50% (HID50) idf dose dependent infectivity is observed
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Background: PubMed 15642976Blaney 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.
- Background: PubMed 15937367Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52.
- Background: PubMed 15566333Guzman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Durbin, MD principal investigator
Center for Immunization Research (CIR), Johns Hopkins School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rDEN3-3'D4delta30 in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and immunogenicity, as assessed by neutralizing antibody titers (time frame: At 4 weeks and 6 weeks after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712803, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.