Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01550289
First received: March 7, 2012
Last updated: September 14, 2016
Last verified: September 2016
  Purpose

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

  • To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.
  • To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:

  • To detect symptomatic dengue cases occurring at any time in the trial.

Condition Intervention Phase
Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: NaCl 0.9% solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

  • Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).

  • Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo [ Time Frame: Day 0 up to Day 14 post each injection ] [ Designated as safety issue: No ]
    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.


Secondary Outcome Measures:
  • Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.

  • Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

  • Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.

  • Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.

  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.

  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.

  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and post each injection ] [ Designated as safety issue: No ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.


Enrollment: 189
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: CYD dengue vaccine
Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue vaccine
Placebo Comparator: Group 2: Placebo
Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively
Biological: Placebo: NaCl 0.9% solution
0.5 ml, Subcutaneous

Detailed Description:
Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 45 years on the day of inclusion
  • Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable)
  • Subject is able to attend all scheduled visits and to comply with all trial procedures
  • Subject in good health, based on medical history and physical examination

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
  • 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
  • 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)
  • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C reported by the subject
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an Investigator or employee of the Investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550289

Locations
India
Bangalore, Karnataka, India, 560054
Ludhiana, Punjab, India, 141008
Kolkata, West Bengal, India, 700073
New Delhi, India, 110002
Pune, India, 411018
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur India Pvt Ltd
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01550289     History of Changes
Other Study ID Numbers: CYD47  UTN: U1111-1114-7909 
Study First Received: March 7, 2012
Results First Received: September 14, 2016
Last Updated: September 14, 2016
Health Authority: India: Drugs Controller General of India
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.

Keywords provided by Sanofi:
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Dengue Virus
Flavivirus

Additional relevant MeSH terms:
Fever
Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016