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A Clinical Phase 3 Study of VLA1553 in Adult Participants With Human Immunodeficiency Virus (HIV)

Primary Purpose

Chikungunya Virus Infection

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
VLA1553
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chikungunya Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants who meet ALL of the following criteria are eligible for this study: Adult participant aged 18 years or above infected with HIV of either gender Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures Stage of disease A1, A2, B1 or B2 according to the revised CDC classification system for HIV infection from 1993 or Stages 1 or 2 in the absence of AIDS defining conditions (CDC update from 1994) Participants are recruited in Cohorts: For Cohort I: Participant has CD4+ T cell counts >350-≤400 cells/μL, is receiving antiretroviral therapy (ART) for at least 6 months and plasma HIV RNA < 400 copies/ mL prior enrollment For Cohort II: Participant has CD4+ T cell counts >200 cells/μL (no upper limit), is receiving ART for at least 3 months and plasma HIV RNA < 50 copies/ mL prior enrollment Participant is seronegative for previous CHIKV exposure (i.e. IgM- and IgG-) as screened by CHIKV-specific ELISA If female participant is of childbearing potential: Participant has a negative urine pregnancy test at screening (Visit 0) or Day 1 (Visit 1), respectively Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0) Participant agrees to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85, Visit 6). Female/male participant agrees to employ adequate birth control measures for the first three months post-vaccination (i.e., until Day 85, Visit 7) Exclusion Criteria: Participants who meet ANY of the following criteria are NOT eligible for this study: Participant 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 Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0) and Visit 1) Participant tests positive for human immunodeficiency virus (HIV) and fulfills AIDS indicator T cell counts or AIDS indicator conditions (disease stages C1, C2 or C3 or stage Participant tests positive for HIV with the actual target disease stages A1, A2, B1 or B2 (or stage 1 or 2), but was classified in the past at least once as fulfilling AIDS indicator conditions (disease stage C1, C2 or C3) or AIDS indicator T cell counts (CD4+ lymphocyte count <200/μL or CD4+ percentage <14%) Participant tests PCR positive for active hepatitis B or hepatitis C virus (HCV) Participant has received any vaccine within 28 days prior to vaccination in this study or plans to receive any vaccine within 28 days after vaccination Participant has abnormal findings in any required study investigations (e.g. medical history, physical examination, and laboratory findings) considered clinically relevant by the Investigator and which pose a risk for participation in the study based on his/her judgement Participant currently has or had a history of significant cardiovascular, respiratory, metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder (of note: Mild asthma that requires low dose corticosteroid inhalation only, during limited time periods of the year is not an exclusion criterion) Participant has an abnormal, clinically significant 12-lead ECG at screening Participant has a history of immune-mediated or clinically relevant arthritis/arthralgia Participant has a history of malignancy Participant has a known or suspected defect of the immune system that can be expected to influence the immune response to the vaccine other than asymptomatic or moderately symptomatic HIV infection, such as participants with congenital immunodeficiency, status post organ transplantation or immuno-suppressive therapy within four weeks prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥0.05 mg/kg/day within 4 weeks prior to study entry, radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous three years; topical and inhaled steroids are allowed Participant has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications including febrile convulsions) Participant presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws Participant is pregnant (positive urine pregnancy test at screening or Visit 1, respectively), is lactating at the time of enrollment, has plans to become pregnant or subject's female partner plans to become pregnant during the first three months post-vaccination or practices unreliable contraception Participant received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study Participant has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating Participant has participated in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to vaccination or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study Participant is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    VLA1553

    Arm Description

    Outcomes

    Primary Outcome Measures

    Solicited adverse events
    To assess frequency and severity of unsolicited AEs
    To assess frequency and relatedness of any serious adverse event (SAE)
    To assess frequency and severity of any early onset adverse event of special interest (AESI)
    To assess frequency and severity of any late onset adverse event of special interest (AESI) during the entire study
    To assess CHIKV viremia
    To assess HIV viral load

    Secondary Outcome Measures

    Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination as determined by μPRNT assay
    Proportion of participants with seroresponse levels post-vaccination as determined by μPRNT assay
    Proportion of participants with seroconversion as compared to baseline as determined by μPRNT assay
    Fold increase of CHIKV-specific neutralizing antibody titers determined by μPRNT assay post-vaccination as compared to baseline
    Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Valneva Austria GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06028841
    Brief Title
    A Clinical Phase 3 Study of VLA1553 in Adult Participants With Human Immunodeficiency Virus (HIV)
    Official Title
    An Open-label Phase 3 Study to Assess the Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Moderately Immunocompromised Adult Participants Infected With Human Immunodeficiency Virus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Valneva Austria GmbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a phase 3 clinical study to evaluate the safety, tolerability, and immunogenicity of VLA1553 in moderately immunocompromised adults with HIV infection.
    Detailed Description
    This is a multicenter, prospective, open-label, uncontrolled, single arm, phase 3 clinical study evaluating the final dose of VLA1553. The safety, tolerability, and immunogenicity of VLA1553 will be assessed in moderately immunocompromised adult participants infected with HIV living in CHIKV endemic areas. Approximately 75 male and female adults (aged 18 years or above) infected with HIV will be enrolled. Participants will be screened by ELISA for evidence of previous CHIKV exposure excluding CHIKV seropositive participants from study participation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chikungunya Virus Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VLA1553
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    VLA1553
    Intervention Description
    Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose
    Primary Outcome Measure Information:
    Title
    Solicited adverse events
    Time Frame
    until Day 15
    Title
    To assess frequency and severity of unsolicited AEs
    Time Frame
    until Day 29 and Day 180 post-vaccination
    Title
    To assess frequency and relatedness of any serious adverse event (SAE)
    Time Frame
    until Day 180 post-vaccination
    Title
    To assess frequency and severity of any early onset adverse event of special interest (AESI)
    Time Frame
    within 2 to 21 days post-vaccination (i.e. Day 3 - Day 22)
    Title
    To assess frequency and severity of any late onset adverse event of special interest (AESI) during the entire study
    Time Frame
    starting 22 days post-vaccination (i.e. Day 23 - Day 180)
    Title
    To assess CHIKV viremia
    Time Frame
    on Days 1, 4, 8 and 15 (Day 29 and Day 57, if applicable)
    Title
    To assess HIV viral load
    Time Frame
    on Days 1, 15, 29, 57, 85, and 180
    Secondary Outcome Measure Information:
    Title
    Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination as determined by μPRNT assay
    Time Frame
    Day 15, Day 29, Day 57, Day 85 and Day 180
    Title
    Proportion of participants with seroresponse levels post-vaccination as determined by μPRNT assay
    Time Frame
    Day 15, Day 29, Day 57, Day 85 and Day 180
    Title
    Proportion of participants with seroconversion as compared to baseline as determined by μPRNT assay
    Time Frame
    Day 29 and Day 180
    Title
    Fold increase of CHIKV-specific neutralizing antibody titers determined by μPRNT assay post-vaccination as compared to baseline
    Time Frame
    Day 15, Day 29, Day 57, Day 85 and Day 180
    Title
    Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay
    Time Frame
    Day 15, Day 29, Day 57, Day 85 and Day 180

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who meet ALL of the following criteria are eligible for this study: Adult participant aged 18 years or above infected with HIV of either gender Participant has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures Stage of disease A1, A2, B1 or B2 according to the revised CDC classification system for HIV infection from 1993 or Stages 1 or 2 in the absence of AIDS defining conditions (CDC update from 1994) Participants are recruited in Cohorts: For Cohort I: Participant has CD4+ T cell counts >350-≤400 cells/μL, is receiving antiretroviral therapy (ART) for at least 6 months and plasma HIV RNA < 400 copies/ mL prior enrollment For Cohort II: Participant has CD4+ T cell counts >200 cells/μL (no upper limit), is receiving ART for at least 3 months and plasma HIV RNA < 50 copies/ mL prior enrollment Participant is seronegative for previous CHIKV exposure (i.e. IgM- and IgG-) as screened by CHIKV-specific ELISA If female participant is of childbearing potential: Participant has a negative urine pregnancy test at screening (Visit 0) or Day 1 (Visit 1), respectively Participant has practiced an adequate method of contraception during the 30 days before screening (Visit 0) Participant agrees to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85, Visit 6). Female/male participant agrees to employ adequate birth control measures for the first three months post-vaccination (i.e., until Day 85, Visit 7) Exclusion Criteria: Participants who meet ANY of the following criteria are NOT eligible for this study: Participant 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 Participant has an acute or recent infection (and who is not symptom-free in the week prior to the Screening Visit (Visit 0) and Visit 1) Participant tests positive for human immunodeficiency virus (HIV) and fulfills AIDS indicator T cell counts or AIDS indicator conditions (disease stages C1, C2 or C3 or stage Participant tests positive for HIV with the actual target disease stages A1, A2, B1 or B2 (or stage 1 or 2), but was classified in the past at least once as fulfilling AIDS indicator conditions (disease stage C1, C2 or C3) or AIDS indicator T cell counts (CD4+ lymphocyte count <200/μL or CD4+ percentage <14%) Participant tests PCR positive for active hepatitis B or hepatitis C virus (HCV) Participant has received any vaccine within 28 days prior to vaccination in this study or plans to receive any vaccine within 28 days after vaccination Participant has abnormal findings in any required study investigations (e.g. medical history, physical examination, and laboratory findings) considered clinically relevant by the Investigator and which pose a risk for participation in the study based on his/her judgement Participant currently has or had a history of significant cardiovascular, respiratory, metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder (of note: Mild asthma that requires low dose corticosteroid inhalation only, during limited time periods of the year is not an exclusion criterion) Participant has an abnormal, clinically significant 12-lead ECG at screening Participant has a history of immune-mediated or clinically relevant arthritis/arthralgia Participant has a history of malignancy Participant has a known or suspected defect of the immune system that can be expected to influence the immune response to the vaccine other than asymptomatic or moderately symptomatic HIV infection, such as participants with congenital immunodeficiency, status post organ transplantation or immuno-suppressive therapy within four weeks prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥0.05 mg/kg/day within 4 weeks prior to study entry, radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous three years; topical and inhaled steroids are allowed Participant has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications including febrile convulsions) Participant presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws Participant is pregnant (positive urine pregnancy test at screening or Visit 1, respectively), is lactating at the time of enrollment, has plans to become pregnant or subject's female partner plans to become pregnant during the first three months post-vaccination or practices unreliable contraception Participant received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study Participant has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating Participant has participated in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to vaccination or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study Participant is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valneva Clinical Development
    Phone
    +43 1 206 20
    Ext
    0
    Email
    office@valneva.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valneva Clinical Development
    Organizational Affiliation
    Valneva Austria GmbH
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Clinical Phase 3 Study of VLA1553 in Adult Participants With Human Immunodeficiency Virus (HIV)

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