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

NCT01550289 | Completed Phase 2 Results DMC

• 2 other identifiers: CYD47UTN: U1111-1114-7909
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 5

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.

Conditions

Dengue; Dengue Fever; Dengue Hemorrhagic Fever

Keywords

Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Dengue Virus; Flavivirus

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• 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

  Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

• 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

  Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

• 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

  Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

• 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

  Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

• 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

  Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)

Study Arms (2)

Group 1: CYD dengue vaccine

EXPERIMENTAL

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

Group 2: Placebo

PLACEBO COMPARATOR

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

Biological: Placebo: NaCl 0.9% solution

Interventions

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

0.5 mL, Subcutaneous

Also known as: CYD Dengue vaccine

Group 1: CYD dengue vaccine

Placebo: NaCl 0.9% solution BIOLOGICAL

0.5 ml, Subcutaneous

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (5)

Unknown Facility

Bangalore, Karnataka, 560054, India

Location

Unknown Facility

Ludhiana, Punjab, 141008, India

Location

Unknown Facility

Kolkata, West Bengal, 700073, India

Location

Unknown Facility

New Delhi, 110002, India

Location

Unknown Facility

Pune, 411018, India

Location

Related 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 Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.

  PMID: 26291554 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Dengue; Severe Dengue

Interventions

Solutions

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur India Pvt Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: April 5, 2022
• Results First Posted: November 3, 2016

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (5)