Clinical trial NCT01550289: Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
Official title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Dengue Virus
Flavivirus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
timeFrame: Day 0 up to Day 14 post each injection
Secondary outcomes:
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
measure: 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
timeFrame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Other outcomes:
Locations:
city: Bangalore
country: India
state: Karnataka
city: Ludhiana
country: India
state: Punjab
city: Kolkata
country: India
state: West Bengal
city: New Delhi
country: India
city: Pune
country: India
Study officials:
affiliation: Sanofi Pasteur India Pvt Ltd
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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 Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.