Dengue VirusPhase 2NCT00740155
Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
A Phase 2 study testing Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero), Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) and Tetravalent CYD-1,2,3,4 Dengue (Vero) in people with Dengue Virus and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Mexico.
Trial summary
This is part of an ongoing effort to develop a satisfactory dengue vaccine: Primary objective: To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates. To describe the immune response after each vaccination of dengue vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever
- What is being tested?
- Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero), Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) and Tetravalent CYD-1,2,3,4 Dengue (Vero)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesMexico
- Study dates
- Aug 2008to Jan 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by medical history, clinical examination, and biological safety parameters
- Aged 18 to 45 years on the day of inclusion.
- Informed consent form signed.
- 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 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
Who cannot join
- History of thymic diseases or thymectomy.
- For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test
- Breast-feeding
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
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- Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening.
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Previous residence in or travel of more than 2 weeks to areas with high dengue infection endemicity.
- Known 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 (i.e. egg, egg products, proteins of rodent or neural origin, gelatin, and thimerosal.
- History of urticaria after hymenoptera envenomation.
- History of flavivirus infection as reported by the subject.
- Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
- Planned travel during the present trial period to areas with high dengue infection endemicity.
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroid therapy (at a dose of a t least 10 mg).
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past 3 months.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Vaccination planned in the 4 weeks following any trial vaccination.
- Flavivirus vaccination planned during the present trial period.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
This is part of an ongoing effort to develop a satisfactory dengue vaccine:
Primary objective:
To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.
To describe the immune response after each vaccination of dengue vaccine.
Read the detailed description
Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
- Being tested
- Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero), Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero), Tetravalent CYD-1,2,3,4 Dengue (Vero), JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
- Keywords
- Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases
- 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.
Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)Biological
0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)Biological
0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)Biological
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
Tetravalent CYD-1,2,3,4 Dengue (Vero)Biological
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)Biological
Also called JE-VAX®
0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) |
| Group 2 | Experimental | Not described Receives: Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) |
| Group 3 | Experimental | Not described Receives: Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) |
| Group 4 | Experimental | Not described Receives: Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero) |
| Group 5 | Active comparator | Not described Receives: Biological: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
Measured: 12 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue VirusStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740155
- Sponsor's protocol ID
- CYD11
- Status last verified
- Mar 2015
- First submitted
- 7 May 2008
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.
PubMed 25483647
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
- ClinicalTrials.gov ID
- NCT00740155
- Acronym / sponsor ID
- CYD11
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
- Keywords
- Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Aug 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.
This is part of an ongoing effort to develop a satisfactory dengue vaccine:
Primary objective:
To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.
To describe the immune response after each vaccination of dengue vaccine.
Detailed description
Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) |
| Group 2 | Experimental | Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero) |
| Group 3 | Experimental | Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) |
| Group 4 | Experimental | Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero) |
| Group 5 | Active comparator | Biological: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy as determined by medical history, clinical examination, and biological safety parameters
- Aged 18 to 45 years on the day of inclusion.
- Informed consent form signed.
- 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 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
Key exclusion criteria (21 listed)
- History of thymic diseases or thymectomy.
- For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test
- Breast-feeding
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
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 |
|---|---|---|
| Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105) | Biological | Group 1 |
| Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105) | Biological | Group 2 |
| Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) | Biological | Group 3 |
| Tetravalent CYD-1,2,3,4 Dengue (Vero)0.5 mL, Subcutaneous (SC) (Day 0 and Day 105) | Biological | Group 4 |
| JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)Also: JE-VAX®0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105) | Biological | Group 5 |
Primary outcome
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
Time frame: 12 months post-vaccination
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 Mar 2015.
- Results publication: PubMed 25483647Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.
- Related InfoLink provided by the sponsor.
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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.
Medical Monitor study director
Sanofi Pasteur Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero), Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero) and Tetravalent CYD-1,2,3,4 Dengue (Vero) in people with Dengue Virus and Dengue Fever, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Mexico.
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 5 inclusion and 21 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 Mar 2015. 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 Mexico. 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?
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine (time frame: 12 months post-vaccination). 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 NCT00740155, 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 3 Mar 2015.