Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

Dengue Fever Clinical Trial

Official title:

Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875524
• Other study ID #: CYD22
• Secondary ID: 2014-001709-41
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: December 2014

Study information

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

Clinical Trial 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.

Description:

Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 45 Years

Eligibility

Inclusion Criteria :

• Aged 2 to 45 years on the day of inclusion.

• 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.

Exclusion Criteria :

• 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.

• Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.

• Familial atopy medical history (parents, brothers, or sisters).

• Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.

• History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).

Related Conditions & MeSH terms

• Dengue
• Dengue Disease
• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Virus
• Fever
• Hyperthermia
• Severe Dengue

Intervention

Biological:
• CYD dengue vaccine serotypes (1, 2, 3, 4).
0.5 mL, Subcutaneous
• Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Each at 0.5 mL, Subcutaneous, respectively

Locations

Country	Name	City	State
Vietnam	Sanofi Pasteur Investigational Site	Long Xuyên	An Giang Province

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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