A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents

NCT04650399 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: VLA1553-321
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 10

Brief Summary

This is a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control will be administered as single immunization on Day 1. Overall, approximately 750 male and female subjects aged 12 years to \<18 years will be enrolled into the study.

Conditions

Chikungunya

Outcome Measures

Primary Outcomes (1)

• Seroprotection

  Proportion of subjects with a seroprotective CHIKV antibody level determined by µPRNT (Micro Plaque Reduction Neutralization Test) for baseline negative subjects 28 days post-vaccination.

  up to Day 29 after single vaccination

Secondary Outcomes (11)

• Immunogenicity

  until Day 8, Day 85, Day 180, and Month 12 after vaccination

• Seroprotection up to 1 year

  until Day 8, Day 29, Day 85, Day 180, and Month 12 after vaccination

• Seroconversion up to 1 year

  12 months after vaccination

• Fold Increase in neutralizing antibodies

  12 months after vaccination

• Proportion of increase of neutralizing antibodies

  12 months after vaccination

Study Arms (2)

Active

EXPERIMENTAL

VLA1553

Biological: Active

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Active BIOLOGICAL

Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose

Active

Placebo BIOLOGICAL

Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• From the 12th birthday to the last day before the 18th birthday on the Day of screening;
• able to provide informed consent as well as written informed consent by the subject's legal representative ;
• generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
• seropositive for previous CHIKV exposure (i.e. IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e. IgM-/IgG-) as screened by CHIKV-specific ELISA.
• for women of childbearing potential:
• negative serum or urine pregnancy test at screening.
• practiced an adequate method of contraception during 30 days before screening
• agrees to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85).

You may not qualify if:

• CHIKV infection in the past, including suspected CHIKV infection; is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical study involving an investigational CHIKV vaccine;
• acute or recent infection;
• tests positive for human immunodeficiency virus (HIV) human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
• live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively;
• abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study;
• medical history of or currently has acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation in the study;
• history of immune-mediated or clinically relevant arthritis / arthralgia;
• history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled;
• known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination;
• history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications);
• with clinical conditions representing a contraindication to intramuscular vaccination and blood draws;
• pregnant or lactating at the time of enrollment;
• donation of blood, blood fractions or plasma within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or plans to donate blood or use blood products until Day 180 of the study;
• rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating;
• known or suspected problem with alcohol or drug abuse as determined by the Investigator;

Sponsors & Collaborators

• Butantan Institute: lead
• Valneva Austria GmbH: collaborator

Study Sites (10)

CECOR - Centro Oncológico de Roraima

Boa Vista, Acre, 69304-015, Brazil

Location

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Manaus, Amazonas, 69040-000, Brazil

Location

Núcleo de Medicina Tropical - Universidade Federal do Ceará

Fortaleza, Ceará, 60020-181, Brazil

Location

Associação Obras Sociais Irmã Dulce / Centro de Pesquisa Clínica - CPEC

Salvador, Estado de Bahia, 40415-180, Brazil

Location

Centro de Pesquisa e Desenvolvimento de Fármacos (CPDF) - Universidade Federal de Minas Gerais, Instituto de Ciências Biológicas

Belo Horizonte, Minas Gerais, 31270-010, Brazil

Location

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, 52010-075, Brazil

Location

Centro de Pesquisas Clínicas Universidade Federal Sergipe

Aracaju, Sergipe, 49100-000, Brazil

Location

Faculdade de Medicina de São José do Rio Preto - FAMERP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Centro de Pesquisa Clínica da Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS

Campo Grande, 79070-900, Brazil

Location

Centro de Estudos do Instituto de Infectologia Emílio Ribas

São Paulo, 01246-900, Brazil

Location

Related Publications (2)

• Buerger V, Pfeiffer A, Schoengrundner P, Seebacher J, Hochreiter R, Kosulin K, Zoihsl O, Weisova P, Mader R, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in adolescents: final results from a 12-month, double-blind, randomised, placebo-controlled, phase 3 trial in endemic areas of Brazil. Lancet Infect Dis. 2025 Dec 8:S1473-3099(25)00631-0. doi: 10.1016/S1473-3099(25)00631-0. Online ahead of print.

  PMID: 41380703 DERIVED

• Buerger V, Hadl S, Schneider M, Schaden M, Hochreiter R, Bitzer A, Kosulin K, Mader R, Zoihsl O, Pfeiffer A, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Dubischar K, Wressnigg N, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in endemic areas of Brazil: interim results of a double-blind, randomised, placebo-controlled phase 3 trial in adolescents. Lancet Infect Dis. 2025 Jan;25(1):114-125. doi: 10.1016/S1473-3099(24)00458-4. Epub 2024 Sep 5.

  PMID: 39243794 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Exercise

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fernanda Boulos, MD, MSc

  Butantan Institute

  STUDY CHAIR

• Valneva Austria GmbH

  Valneva Austria GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 2, 2020
• Study Start: January 31, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 15, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

BR (10)