Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

NCT00875524 | Completed Phase 2 Results

• 2 other identifiers: CYD222014-001709-41
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives:

• To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
• To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
• To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.

Conditions

Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Disease

Keywords

Dengue virus; Dengue fever; Dengue hemorrhagic fever; Dengue diseases; Dengue vaccine

Outcome Measures

Primary Outcomes (6)

• Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine

  Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).

  Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3

• Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period

  GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.

  Year 1, Year 2, Year 3 and Year 4 after the Third Injection

• Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine

  Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.

  Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3

• Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period

  Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.

  Year 1, Year 2, Year 3 and Year 4 after the Third Injection

• Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine

  Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm.

  7 days post-each injection

• Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine

  Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.

  14 days post-each injection

Study Arms (2)

CYD Dengue Vaccine Group

EXPERIMENTAL

Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.

Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).

Control Vaccine Group

SHAM COMPARATOR

Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.

Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Interventions

CYD dengue vaccine serotypes (1, 2, 3, 4). BIOLOGICAL

0.5 mL, Subcutaneous

Also known as: ChimeriVax™

CYD Dengue Vaccine Group

Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide BIOLOGICAL

Each at 0.5 mL, Subcutaneous, respectively

Also known as: Meningococcal Polysaccharide Vaccine A+C, NaCl, Typhim Vi®

Control Vaccine Group

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years).
• Participant (and parent/guardian for participants \<18 years) able to attend all scheduled visits and to comply with all trial procedures.
• For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
• Participant in good health, based on medical history, physical examination and laboratory parameters.

You may not qualify if:

• Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
• For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
• For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
• Breast-feeding female participant.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
• Planned participation in another clinical trial during the first year of the study.
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy.
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
• Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Sanofi Pasteur Investigational Site

Long Xuyen, An Giang, Vietnam

Location

MeSH Terms

Conditions

Dengue; Severe Dengue

Interventions

ChimeriVax; Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

None reported.

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur SA

Contact-US@sanofi.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind- observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor participant had access.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 5, 2022
• Results First Posted: July 24, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)