Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults

Dengue Fever Clinical Trial

Official title:

Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740155
• Other study ID #: CYD11
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: March 2, 2015
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical 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.

Description:

Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria :

• 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.

Exclusion Criteria :

• 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue
• Dengue Diseases
• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Virus
• Fever
• Severe Dengue

Intervention

Biological:
• 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)
• 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)
• Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
• Tetravalent CYD-1,2,3,4 Dengue (Vero)
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)
0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Dayan GH, Galán-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naïve adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine		12 months post-vaccination	Yes

External Links

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