ChikungunyaPhase 1NCT03382964
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
A Phase 1 study testing VLA1553 in people with Chikungunya, run by Valneva Austria GmbH at 2 sites in United States.
Trial summary
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya
- What is being tested?
- VLA1553
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Mar 2018to 28 Jul 2019
- Phase
- Phase 1
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 45 years on the Day of screening;
- Has a BMI of ≥ 18.5 and < 30 kg/m2 on the Day of screening;
- Understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
- Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
- If female, subject is of non-childbearing potential. The definition of non-childbearing potential includes the following:
- Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian tube ligation; endometrial ablation), at least 30 days prior to signature of the Informed Consent form;
- At least 5 years post-menopause (i.e., 6 years post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing.
Who cannot join
- History of known CHIKV infection;
- Plans to travel to areas with active CHIKV transmission during the course of the study or history of travel to an endemic CHIKV area within 4 weeks prior to study enrollment;
- Participation in a clinical study involving an investigational CHIKV vaccine;
- Receipt of an inactivated vaccine within 4 weeks or live vaccine within 8 weeks prior to vaccination in this study;
- Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
- (1) Abnormal laboratory liver function values (≥ grade 1), (2) any grade 1 abnormal lab values deemed clinically relevant by the Investigator, and (3) any ≥ grade 2 abnormal lab values irrespective of clinical significance at screening;
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- Clinically significant abnormal ECG at screening;
- History of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder;
- History of immune-mediated or clinically significant arthritis/arthralgia;
- History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved a cure;
- Disease or recent or current treatment that can be expected to influence immune response as specified in the protocol;
- History of severe hypersensitivity reactions or anaphylaxis;
- History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications);
- Acute febrile infections within two weeks prior to vaccination;
- Subject is of childbearing potential or lactating at the time of enrollment;
- Blood donation within 30 days or receipt of blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or during the course of the study;
- A 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;
- Any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
- Participation in another clinical study involving an investigational medicinal product within 30 days prior to study enrollment or during the course of this study;
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Optimal Research, LLC
Huntsville, Alabama, 35802
Optimal Research, LLC
Peoria, Illinois, 61614
About this study
Official title: A Randomized, Observer-Blinded, Dose-Escalation Phase 1 Study to Assess the Safety and Immunogenicity of Three Different Dose Levels of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers Aged 18 To 45 Years
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization.
120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms.
Read more
A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia.
Study participants will be followed up until 13 months after initial vaccination.
- Conditions
- Chikungunya
- Being tested
- VLA1553
- Keywords
- VLA1553, Chikungunya, CHIKV, Live-attenuated Chikungunya virus vaccine
- 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
I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate
| Study group | Role | What they receive |
|---|---|---|
| VLA1553 low dose | Active comparator | VLA1553 with 3.2x10^3 TCID50/ 100 µL (microliter). Re-vaccination at Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL (milliliter) Receives: Biological: VLA1553 |
| VLA1553 medium dose | Active comparator | VLA1553 with 3.2x10^4 TCID50/ 1 mL Re-vaccination at Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL Receives: Biological: VLA1553 |
| VLA1553 high dose | Active comparator | VLA1553 with 3.2x10^5 TCID50/ 1 mL Re-vaccination at Month 6 or Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL Receives: Biological: VLA1553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Measured: up to Day 14 after single vaccination
Severity of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Measured: up to Day 14 after single vaccination
Frequency of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Measured: up to Day 14 after single vaccination
Severity of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
Measured: up to Day 14 after single vaccination
Secondary outcomes (8)
Frequency of any adverse event (AE)
Measured: until Day 14, Day 28 and throughout the study period
Severity of any adverse event (AE)
The investigator will assess the severity of AEs using his/her clinical expertise and judgment based on the most appropriate description (mild, moderate, severe) as per study protocol
Measured: until Day 14, Day 28 and throughout the study period
Frequency of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Measured: until Day 14, Day 28 and throughout the study period
Severity of solicited injection site reactions
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Measured: until Day 14, Day 28 and throughout the study period
Frequency of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Measured: until Day 14, Day 28 and throughout the study period
Severity of solicited systemic reactions
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
Measured: until Day 14, Day 28 and throughout the study period
Assessment of viremia after each vaccination
Assessment of CHIKV viremia will be done by RT (real-time)-qPCR (quantitative polymerase chain reaction) in blood and urine
Measured: on Days 3, 7, 14 and beyond Day 14 after re-vaccination
Immune response as measured by CHIKV-specific neutralizing antibody titer as determined by micro-neutralization (μNT) assay.
Measured: Day 28, Day 84, Month 6, Month 12, and 28 days after re-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start5 Mar 2018
- Primary completion13 Jul 2018
- Study completion28 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChikungunyaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nina Wressnigg, Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382964
- Sponsor's protocol ID
- VLA1553-101
- Status last verified
- Aug 2019
- First submitted
- 12 Dec 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bezay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Corbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bender W. Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial. Lancet Infect Dis. 2020 Oct;20(10):1193-1203. doi: 10.1016/S1473-3099(20)30238-3. Epub 2020 Jun 1.
PubMed 32497524
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Dose-Escalation Phase 1 Study to Assess the Safety and Immunogenicity of Three Different Dose Levels of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers Aged 18 To 45 Years
- ClinicalTrials.gov ID
- NCT03382964
- Acronym / sponsor ID
- VLA1553-101
- Conditions
- Chikungunya
- Keywords
- VLA1553, Chikungunya, CHIKV, Live-attenuated Chikungunya virus vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 28 Jul 2019 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization.
120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms.
A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia.
Study participants will be followed up until 13 months after initial vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLA1553 low dose | Active comparator | Biological: VLA1553VLA1553 with 3.2x10^3 TCID50/ 100 µL (microliter). Re-vaccination at Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL (milliliter) |
| VLA1553 medium dose | Active comparator | Biological: VLA1553VLA1553 with 3.2x10^4 TCID50/ 1 mL Re-vaccination at Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL |
| VLA1553 high dose | Active comparator | Biological: VLA1553VLA1553 with 3.2x10^5 TCID50/ 1 mL Re-vaccination at Month 6 or Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18 to 45 years on the Day of screening;
- Has a BMI of ≥ 18.5 and < 30 kg/m2 on the Day of screening;
- Understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
- Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
- If female, subject is of non-childbearing potential. The definition of non-childbearing potential includes the following:
Key exclusion criteria (21 listed)
- History of known CHIKV infection;
- Plans to travel to areas with active CHIKV transmission during the course of the study or history of travel to an endemic CHIKV area within 4 weeks prior to study enrollment;
- Participation in a clinical study involving an investigational CHIKV vaccine;
- Receipt of an inactivated vaccine within 4 weeks or live vaccine within 8 weeks prior to vaccination in this study;
- Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLA1553I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate | Biological | VLA1553 high dose, VLA1553 low dose, VLA1553 medium dose |
Primary outcome
Frequency of solicited injection site reactions
Time frame: up to Day 14 after single vaccination
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Severity of solicited injection site reactions
Time frame: up to Day 14 after single vaccination
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Frequency of solicited systemic reactions
Time frame: up to Day 14 after single vaccination
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Severity of solicited systemic reactions
Time frame: up to Day 14 after single vaccination
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
8 secondary outcomes
Frequency of any adverse event (AE)
Time frame: until Day 14, Day 28 and throughout the study period
Severity of any adverse event (AE)
Time frame: until Day 14, Day 28 and throughout the study period
Frequency of solicited injection site reactions
Time frame: until Day 14, Day 28 and throughout the study period
Severity of solicited injection site reactions
Time frame: until Day 14, Day 28 and throughout the study period
Frequency of solicited systemic reactions
Time frame: until Day 14, Day 28 and throughout the study period
Severity of solicited systemic reactions
Time frame: until Day 14, Day 28 and throughout the study period
Assessment of viremia after each vaccination
Time frame: on Days 3, 7, 14 and beyond Day 14 after re-vaccination
Immune response as measured by CHIKV-specific neutralizing antibody titer as determined by micro-neutralization (μNT) assay.
Time frame: Day 28, Day 84, Month 6, Month 12, and 28 days after re-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 32497524Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bezay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Corbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bender W. Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial. Lancet Infect Dis. 2020 Oct;20(10):1193-1203. doi: 10.1016/S1473-3099(20)30238-3. Epub 2020 Jun 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Wressnigg study chair
Valneva Austria GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLA1553 in people with Chikungunya, run by Valneva Austria GmbH at 2 sites in United States.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of solicited injection site reactions (time frame: up to Day 14 after single vaccination). The study lists 4 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 NCT03382964, which also lists 1 linked publication.
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 29 Aug 2019.