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

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ClinicalTrials.gov Identifier: NCT06106581
Recruitment Status : Recruiting
First Posted : October 30, 2023
Last Update Posted : April 19, 2024
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Description
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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).


Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Biological: VLA1553 full dose Biological: VLA1553 half dose Biological: Control Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 18, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: VLA1553 full dose Biological: VLA1553 full dose
Single intramuscular vaccination on Day 1 with VLA1553 full dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Experimental: VLA1553 half dose Biological: VLA1553 half dose
Single intramuscular vaccination on Day 1 with VLA1553 half dose, a lyophilized live-attenuated Chikungunya vaccine candidate
Active Comparator: Control
Single intramuscular vaccination on Day 1 with Nimenrix (Men ACWY vaccine), a conjugate vaccine indicated for the active immunization
 Biological: Control
Nimenrix


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of solicited injection site reactions [ Time Frame: within 14 days post-vaccination ]
  2. Severity of solicited injection site reactions [ Time Frame: within 14 days post-vaccination ]
  3. Frequency of systemic reactions [ Time Frame: within 14 days post-vaccination ]
  4. Severity of systemic reactions [ Time Frame: within 14 days post-vaccination ]

Secondary Outcome Measures :
  1. Frequency of any adverse event (AE) [ Time Frame: within 28 days post-vaccination ]
  2. Severity of any adverse event (AE) [ Time Frame: within 28 days post-vaccination ]
  3. Frequency of unsolicited AE [ Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination ]
  4. Severity of unsolicited AE [ Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination ]
  5. Frequency of any serious adverse event (SAE) [ Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination ]
  6. Severity of any serious adverse event (SAE) [ Time Frame: until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination ]
  7. Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers [ Time Frame: on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06106581


Contacts
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Contact: Valneva Clinical Development +4 1 206 20 ext 0 office@valneva.com

Locations
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Dominican Republic
Fundacion Dominicana de Perinatologia Fundacion Probebe Recruiting
Santo Domingo, Gazcue, Dominican Republic
Contact: Sonia Mazara, Dr.         
Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP Recruiting
Santo Domingo, Dominican Republic, 10306
Contact: Yeycy Donastorg, Dr.         
Honduras
Inversiones en Investigacion Medica INVERIME Recruiting
Tegucigalpa, Honduras
Contact: Maribel Rivera, Dr.         
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Chair: Valneva Clinical Development Valneva Austria GmbH
More Information
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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT06106581    
Other Study ID Numbers: VLA1553-221
First Posted: October 30, 2023    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Virus Diseases
Infections
Alphavirus Infections
Arbovirus Infections
 Vector Borne Diseases
Mosquito-Borne Diseases
Togaviridae Infections
RNA Virus Infections