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Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

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ClinicalTrials.gov Identifier: NCT01134263
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus Biological: Placebo: NaCl 0.9% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: An observer-blind procedure was followed for the three injections with CYD dengue vaccine or placebo. Neither the observer, Investigator, Sponsor, nor the participant knew which product was administered.
Primary Purpose: Prevention
Official Title: Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Actual Study Start Date : October 5, 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1),Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)
Other Name: CYD Dengue vaccine

Experimental: CYD Dengue vaccine - Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC
Other Name: CYD Dengue vaccine

Experimental: CYD Dengue vaccine - Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC
Other Name: CYD Dengue vaccine

Experimental: CYD Dengue vaccine - Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)
Other Name: CYD Dengue vaccine

Placebo Comparator: Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Biological: Placebo: NaCl 0.9%
0.5 ml, SC
Other Name: NaCl




Primary Outcome Measures :
  1. 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 [ Time Frame: 28 days post-injection 3 ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 28 days post-Injection 3 ]
    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.

  2. Number of Participants With Solicited Injection Site Reactions After Any Vaccination [ Time Frame: 7 days post 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.

  3. Number of Participants With Solicited Systemic Reactions After Any Vaccination [ Time Frame: 14 days post 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134263


Locations
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Australia
Adelaide, Australia, SA 5000
Carina Heights, Australia, QLD 4152
Enoggera, Australia, QLD 4051
Heidelberg, Australia, VIC 3084
Herston, Australia, QLD 4006
Herston, Australia, QLD 4029
Subiaco, Australia, WA 6008
Westmead, Australia, NSW 2145
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01134263     History of Changes
Other Study ID Numbers: CYD17
U1111-1114-7646 ( Other Identifier: WHO )
First Posted: May 31, 2010    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: May 2019
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Lot Consistency
Additional relevant MeSH terms:
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Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs