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DenguePhase 2NCT00730288

Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

A Phase 2 study testing Chimeric dengue serotype (1, 2, 3, 4) in people with Dengue and Dengue Fever, run by Sanofi at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine Primary Objectives: To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Dengue, Dengue Fever, Dengue Hemorrhagic Fever
What is being tested?
Chimeric dengue serotype (1, 2, 3, 4)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteAustralia
Study dates
Aug 2006to Jan 2008
Phase
Phase 2
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18 to 40 years on the day of inclusion.
  • Informed consent form signed.
  • For a woman, inability to bear a child or negative serum pregnancy test.
  • Completed the one-year follow-up of Study DIV12.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.

Who cannot join

  • History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
  • Breast-feeding.
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Planned participation in another clinical trial during the present trial period.
Show all 19Show fewer
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past three months.
  • Vaccination planned in the four weeks following the trial vaccination.
  • Flavivirus vaccination planned during the present trial period.
  • Planned travel during the present trial period to areas with high dengue endemicity.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
  • Participation in another clinical trial in the four weeks preceding the trial vaccination.
  • Any vaccination in the four weeks preceding the trial vaccination.
  • Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
  • Positive flavivirus serological test in blood sample taken at screening (for Controls only).

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Study site

    Adelaide

Other trials in Australia

About this study

Official title: Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine

To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine

Primary Objectives:

  • To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
  • To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
Read the detailed description

This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.

Being tested
Chimeric dengue serotype (1, 2, 3, 4)
Keywords
Dengue, Dengue fever, Dengue hemorrhagic fever, Dengue virus
Medical subject headings
Dengue, Severe Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chimeric dengue serotype (1, 2, 3, 4)Biological

    Also called ChimeriVax™ Dengue Tetravalent Vaccine

    0.5 mL, Subcutaneous, 1 dose

  • Chimeric dengue serotype (1, 2, 3, 4)Biological

    Also called ChimeriVax™ Dengue Tetravalent Vaccine

    0.5 mL, Subcutaneous, 1 dose

  • Chimeric dengue serotype (1, 2, 3, 4)Biological

    Also called ChimeriVax™ Dengue Tetravalent Vaccine

    0.5mL, Subcutaneous, 1 dose

Study groups in NCT00730288
Study groupRoleWhat they receive
1ExperimentalReceived monovalent Vero dengue vaccine in Study DIV12
Receives: Biological: Chimeric dengue serotype (1, 2, 3, 4)
2ExperimentalReceived Yellow fever vaccine in Study DIV12
Receives: Biological: Chimeric dengue serotype (1, 2, 3, 4)
3ExperimentalFlavivirus-naive subjects
Receives: Biological: Chimeric dengue serotype (1, 2, 3, 4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™

    Measured: 28, 60 and 180 days post vaccination

  2. Safety: To provide information concerning the safety of ChimeriVax™

    Measured: 28 days post-vaccination and entire study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study startAug 2006
  3. Primary completionAug 2007
  4. Study completionJan 2008

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00730288
Sponsor's protocol ID
CYD10
Status last verified
Feb 2018
First submitted
6 Aug 2008
Last updated
27 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Qiao M, Shaw D, Forrat R, Wartel-Tram A, Lang J. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011 Oct;85(4):724-31. doi: 10.4269/ajtmh.2011.10-0436.

    PubMed 21976579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chimeric dengue serotype (1, 2, 3, 4) in people with Dengue and Dengue Fever, run by Sanofi at 1 site in Australia.

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 6 inclusion and 19 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 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ (time frame: 28, 60 and 180 days post 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 NCT00730288, which also lists 1 linked publication.

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 27 Feb 2018.

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