Clinical trial NCT01134263: Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Official title: Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Lot Consistency
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-31
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 28 days post-injection 3
Secondary outcomes:
measure: 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
timeFrame: 28 days post-Injection 3
measure: Number of Participants With Solicited Injection Site Reactions After Any Vaccination
timeFrame: 7 days post any vaccination
measure: Number of Participants With Solicited Systemic Reactions After Any Vaccination
timeFrame: 14 days post any vaccination
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Carina Heights
country: Australia
city: Enoggera
country: Australia
city: Heidelberg
country: Australia
city: Herston
country: Australia
city: Herston
country: Australia
city: Subiaco
country: Australia
city: Westmead
country: Australia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. Vaccine. 2015 Sep 22;33(39):5127-34. doi: 10.1016/j.vaccine.2015.08.008. Epub 2015 Aug 13.
citation: Torresi J, Richmond PC, Heron LG, Qiao M, Marjason J, Starr-Spires L, van der Vliet D, Jin J, Wartel TA, Bouckenooghe A. Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding. J Infect Dis. 2017 Oct 17;216(7):834-841. doi: 10.1093/infdis/jix314.