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Chikungunya Virus InfectionPhase 3NCT06028841

A Clinical Phase 3 Trial of VLA1553 in Adult Participants with Human Immunodeficiency Virus (HIV)

A Phase 3 study testing VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This was a phase 3 clinical study to evaluate the safety, tolerability, and immunogenicity of VLA1553 in moderately immunocompromised adults with HIV infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chikungunya Virus Infection
What is being tested?
VLA1553
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Apr 2024to 27 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who met ALL of the following criteria were 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:
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  • 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)

Who cannot join

  • Participants who met ANY of the following criteria were 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)
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  • 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.

About this study

Official title: An Open-label Phase 3 Trial to Assess the Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Moderately Immunocompromised Adult Participants Infected with Human Immunodeficiency Virus

This was a phase 3 clinical study to evaluate the safety, tolerability, and immunogenicity of VLA1553 in moderately immunocompromised adults with HIV infection.

Read the detailed description

This was 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 should have been 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 should have been enrolled. Participants would have been screened by ELISA for evidence of previous CHIKV exposure excluding CHIKV seropositive participants from study participation.

Being tested
VLA1553
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLA1553Biological

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

Study groups in NCT06028841
Study groupRoleWhat they receive
VLA1553ExperimentalNot described
Receives: Biological: VLA1553

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Solicited adverse events

    Measured: until Day 15

  2. To assess frequency and severity of unsolicited AEs

    Measured: until Day 29 and Day 180 post-vaccination

  3. To assess frequency and relatedness of any serious adverse event (SAE)

    Measured: until Day 180 post-vaccination

  4. To assess frequency and severity of any early onset adverse event of special interest (AESI)

    Measured: within 2 to 21 days post-vaccination (i.e. Day 3 - Day 22)

  5. To assess frequency and severity of any late onset adverse event of special interest (AESI) during the entire study

    Measured: starting 22 days post-vaccination (i.e. Day 23 - Day 180)

  6. To assess CHIKV viremia

    Measured: on Days 1, 4, 8 and 15 (Day 29 and Day 57, if applicable)

  7. To assess HIV viral load

    Measured: on Days 1, 15, 29, 57, 85, and 180

Secondary outcomes (5)

  1. Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination as determined by μPRNT assay

    Measured: Day 15, Day 29, Day 57, Day 85 and Day 180

  2. Proportion of participants with seroresponse levels post-vaccination as determined by μPRNT assay

    Measured: Day 15, Day 29, Day 57, Day 85 and Day 180

  3. Proportion of participants with seroconversion as compared to baseline as determined by μPRNT assay

    Measured: Day 29 and Day 180

  4. Fold increase of CHIKV-specific neutralizing antibody titers determined by μPRNT assay post-vaccination as compared to baseline

    Measured: Day 15, Day 29, Day 57, Day 85 and Day 180

  5. 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

    Measured: Day 15, Day 29, Day 57, Day 85 and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start10 Apr 2024
  3. Primary completion27 Aug 2024
  4. Study completion27 Aug 2024

Why it stopped: Withdrawn due to challenges related to recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028841
Sponsor's protocol ID
VLA1553-304
Status last verified
Nov 2024
First submitted
29 Mar 2023
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited adverse events (time frame: until Day 15). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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