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

NCT ID: NCT01550289

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Dengue; Dengue Fever; Dengue Hemorrhagic Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1: CYD dengue vaccine

Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.

Group Type: EXPERIMENTAL

Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus

Intervention Type: BIOLOGICAL

0.5 mL, Subcutaneous

Group 2: Placebo

Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively

Group Type: PLACEBO_COMPARATOR

Placebo: NaCl 0.9% solution

Intervention Type: BIOLOGICAL

0.5 ml, Subcutaneous

Interventions

Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus

0.5 mL, Subcutaneous

Intervention Type: BIOLOGICAL

Placebo: NaCl 0.9% solution

0.5 ml, Subcutaneous

Intervention Type: BIOLOGICAL

Other Intervention Names

CYD Dengue vaccine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur India Pvt Ltd

Locations

Bangalore, Karnataka, India

Ludhiana, Punjab, India

Kolkata, West Bengal, India

New Delhi, , India

Pune, , India

Countries

India

References

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.

Reference Type: RESULT

PMID: 26291554 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

UTN: U1111-1114-7909

Identifier Type: OTHER

Identifier Source: secondary_id

CYD47

Identifier Type: -

Identifier Source: org_study_id