Clinical trial NCT06106581: A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chikungunya Virus Infection
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 304
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of solicited injection site reactions
timeFrame: within 14 days post-vaccination
measure: Severity of solicited injection site reactions
timeFrame: within 14 days post-vaccination
measure: Frequency of systemic reactions
timeFrame: within 14 days post-vaccination
measure: Severity of systemic reactions
timeFrame: within 14 days post-vaccination
Secondary outcomes:
measure: Frequency of any adverse event (AE)
timeFrame: within 28 days post-vaccination
measure: Severity of any adverse event (AE)
timeFrame: within 28 days post-vaccination
measure: Frequency of unsolicited AE
timeFrame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
measure: Severity of unsolicited AE
timeFrame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
measure: Frequency of any serious adverse event (SAE)
timeFrame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
measure: Severity of any serious adverse event (SAE)
timeFrame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
measure: Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers
timeFrame: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Fundacion Dominicana de Perinatologia Fundacion Probebe
state: Gazcue
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP
city: Tegucigalpa
country: Honduras
facility: Inversiones en Investigacion Medica INVERIME
Study officials:
affiliation: Valneva Austria GmbH
name: Valneva Clinical Development
role: STUDY_CHAIR
References: