Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Dengue Fever Clinical Trial

Official title:

Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134263
• Other study ID #: CYD17
• Secondary ID: U1111-1114-7646
• Status: Completed
• Phase: Phase 3
• Start date: October 5, 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2019
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses.

Primary Objective

• To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes.

Secondary Objectives:

• To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.

• To describe the safety of the CYD dengue vaccine in all participants after each dose.

Description:

All participants received 3 doses of their assigned vaccine or placebo and provided blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety data were collected in all participants after each dose and throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 60 years on the day of inclusion.

• Informed consent form was signed and dated.

• Able to attend all scheduled visits and to comply with all trial procedures.

• For a woman of childbearing potential, use of an effective method of contraception, or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination (i.e., for 14 months).

Exclusion Criteria:

• Known pregnancy, or a positive urine pregnancy test.

• History of flavivirus infection or vaccination or prolonged habitation in a dengue endemic area.

• Currently breastfeeding a child.

• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for pandemic influenza vaccination.

• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

• Self-reported seropositivity for human immunodeficiency virus (HIV).

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.

• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.

• Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Dengue Hemorrhagic Fever
• Fever
• Severe Dengue

Intervention

Biological:
• Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)
• Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC
• Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC
• Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)
• Placebo: NaCl 0.9%
0.5 ml, SC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Torresi J, Heron LG, Qiao M, Marjason J, Chambonneau L, Bouckenooghe A, Boaz M, van der Vliet D, Wallace D, Hutagalung Y, Nissen MD, Richmond PC. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Va — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine	GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.	28 days post-injection 3
Secondary	Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine	GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.	28 days post-Injection 3
Secondary	Number of Participants With Solicited Injection Site Reactions After Any Vaccination	Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.	7 days post any vaccination
Secondary	Number of Participants With Solicited Systemic Reactions After Any Vaccination	Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.	14 days post any vaccination