A Phase 2 Clinical Study of VLA1553 in Healthy Children Aged 1 to 11 Years

Chikungunya Virus Infection Clinical Trial

Official title:

A Randomized, Observer-blinded, Dose Response Phase 2 Trial to Assess the Safety and Immunogenicity of Two Different Dose Levels of a Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Healthy Children Aged 1 to 11 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106581
• Other study ID #: VLA1553-221
• Status: Recruiting
• Phase: Phase 2
• Start date: December 18, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Valneva Austria GmbH
• Contact: Valneva Clinical Development
• Phone: +4 1 206 20
• Email: office[@]valneva.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control. At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

Description:

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control (Nimenrix, a tetravalent meningococcal vaccine - Men ACWY). At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (Nimenrix) (n=60). As a safety precaution measure, the first 30 sentinel participants will be enrolled into the trial in an open-label fashion according to an age step down scheme. After sentinel analysis, participants will be enrolled in a blinded, randomized manner into three Trial Arms. Within each treatment arm participants will be stratified into three age strata: Stratum A: 7 to 11 years -children from their 7th birthday until the day before their 12th birthday. Stratum B: 3 to 6 years - children from their 3rd birthday until the day before their 7th birthday. Stratum C: 1 to 2 years - children from their 1st birthday until the day before their 3rd birthday. Age strata for the VLA1553 treatment arms are targeted to be equal in size, i.e., approximately 40 per age stratum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 11 Years

Eligibility

Inclusion Criteria:

1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination;

2. Written informed consent by the participant's parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to local requirements, and written informed assent of the participant, if applicable;

Exclusion Criteria:

1. Participant who is IgM+/IgG- does not qualify for participation in this trial.

2. Participant is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical trial involving an investigational CHIKV vaccine;

3. Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0)

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus Infection

Intervention

Biological:
• VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
• VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
• Control
Nimenrix

Locations

Country	Name	City	State
Dominican Republic	Fundacion Dominicana de Perinatologia Fundacion Probebe	Santo Domingo	Gazcue
Dominican Republic	Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP	Santo Domingo
Honduras	Inversiones en Investigacion Medica INVERIME	Tegucigalpa

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Dominican Republic,  Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of solicited injection site reactions		within 14 days post-vaccination
Primary	Severity of solicited injection site reactions		within 14 days post-vaccination
Primary	Frequency of systemic reactions		within 14 days post-vaccination
Primary	Severity of systemic reactions		within 14 days post-vaccination
Secondary	Frequency of any adverse event (AE)		within 28 days post-vaccination
Secondary	Severity of any adverse event (AE)		within 28 days post-vaccination
Secondary	Frequency of unsolicited AE		until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Secondary	Severity of unsolicited AE		until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Secondary	Frequency of any serious adverse event (SAE)		until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Secondary	Severity of any serious adverse event (SAE)		until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Secondary	Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers		on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination