Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01550289
Other study ID # CYD47
Secondary ID UTN: U1111-1114-
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2012
Est. completion date February 2014

Study information

Verified date March 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Intervention

Biological:
Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Placebo: NaCl 0.9% solution
0.5 ml, Subcutaneous

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

India, 

References & Publications (1)

Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vac — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Primary 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 Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Primary Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Primary 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 Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Primary Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo 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. Day 0 up to Day 14 post each injection
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Secondary 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 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. Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
See also
  Status Clinical Trial Phase
Completed NCT05321264 - Educational Intervention to Promote Control Behaviors and Prevention of Dengue N/A
Completed NCT01436396 - Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers Phase 3
Completed NCT01391819 - Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children N/A
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02833584 - Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults N/A
Completed NCT02433652 - Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2 Phase 1
Enrolling by invitation NCT02016027 - Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter Phase 1
Completed NCT01477671 - Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children N/A
Recruiting NCT00377754 - Prospective Study of Infant Dengue N/A
Recruiting NCT05919277 - A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
Recruiting NCT04582474 - Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso N/A
Completed NCT01983553 - Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Completed NCT03803618 - Dengue Effectiveness Study in the Philippines
Active, not recruiting NCT05967455 - Homologous Re-infection With Dengue 1 or Dengue 3 Phase 1
Completed NCT03631719 - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Recruiting NCT02606019 - The Use of Biomarkers in Predicting Dengue Outcome N/A
Completed NCT02372175 - Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain Phase 1
Active, not recruiting NCT01696422 - Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine Phase 2
Completed NCT00993447 - Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America Phase 2
Completed NCT00375726 - Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults Phase 1

External Links