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Zika VirusPhase 1NCT03425149

Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults

A Phase 1 study testing VLA1601 in people with Zika Virus and Zika Virus Infection, run by Valneva Austria GmbH at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Zika Virus, Zika Virus Infection
What is being tested?
VLA1601
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteUnited States
Study dates
24 Feb 2018to 16 Nov 2018
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject is 18 to 49 years of age on the day of screening (Visit 0);
  • Subject has a Body Mass Index (BMI) of ≥18.5 and <30 kg/m2 on the day of screening (Visit 0);
  • Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
  • Subject is generally healthy as determined by the Investigator's clinical judgment based on medical history, physical examination and screening laboratory tests;
  • If subject is of childbearing potential:
  • Subject has a negative serum pregnancy test at screening (Visit 0);
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  • Subject agrees to employ adequate birth control measures for the duration of the study. This includes one of the following measures:
  • Hormonal contraceptives (e.g. implants, birth control pills, patches) since ≥30 days prior to first vaccination;
  • Intrauterine device;
  • Barrier type of birth control measure (e.g. condoms, diaphragms, cervical caps);
  • Vasectomy in the male sex partner ≥3 months prior to first vaccination;

Who cannot join

  • Subject has a history of known flavivirus infection, or vaccination with a licensed or investigational flavivirus vaccine;
  • Subject has plans to receive a licensed flavivirus vaccine during the course of the study;
  • Subject has plans to travel to areas (including within the US) with active ZIKV, Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) transmission during the course of the study or has travelled to a flavivirus-endemic area within 4 weeks prior to study enrollment;
  • Subject is seropositive to ZIKV, JEV, DENV or West Nile virus (WNV);
  • Subject has received an inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to vaccination in this study;
  • Subject has clinically significant abnormal laboratory values, as determined by the Investigator, at screening (Visit 0);
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  • Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
  • Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barré syndrome), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder;
  • Subject has a disease or is undergoing a form of treatment or was undergoing a form of treatment within 4 weeks prior to study enrollment (i.e. subject randomized) that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled (low dose), intranasal or topical steroids is permitted);
  • Subject has a history of severe hypersensitivity reactions or anaphylaxis;
  • Subject has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications);
  • Subject had acute febrile infections within two weeks prior to vaccination in this study;
  • Subject has donated blood 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 during the course of the study;
  • Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating;
  • Subject is currently enrolled or has participated in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP or investigational device during the course of this study;
  • Subject has plans to become pregnant during the course of the study, or is pregnant (positive serum pregnancy test at screening) or lactating at the time of study enrollment;
  • Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
  • Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
  • Subject is a member of the team conducting this study or is 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;
  • Subject has any condition that, in the opinion of the Investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Observer-blinded Phase 1 Study to Assess the Safety and Immunogenicity of Two Different Dose Levels of an Alum Adjuvanted Inactivated Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years

In this Phase 1 study, two target dose levels of VLA1601, a purified, inactivated, whole Zika virus (ZIKV) vaccine candidate adsorbed on aluminum hydroxide (alum) will be evaluated: 6 antigen units (AU) and 3 AU of inactivated ZIKV vaccine. Each dose will be administered intramuscularly (i.m.) in the deltoid muscle on Days 0 and 28. In addition, an accelerated 2-dose vaccination schedule on Days 0 and 7 will be assessed for both doses.

Being tested
VLA1601, Placebo
Keywords
vaccine, prevention
Medical subject headings
Zika Virus Infection

What participants receive

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

  • VLA1601Biological

    purified inactivated ZIKV vaccine candidate adsorbed on alum

  • PlaceboBiological

    Phosphate buffered saline (PBS)

Study groups in NCT03425149
Study groupRoleWhat they receive
Treatment Group IExperimental0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7
Receives: Biological: VLA1601; Biological: Placebo
Treatment Group IIExperimental0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28
Receives: Biological: VLA1601; Biological: Placebo
Treatment Group IIIExperimental0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7
Receives: Biological: VLA1601; Biological: Placebo
Treatment Group IVExperimental0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28
Receives: Biological: VLA1601; Biological: Placebo
Treatment Group VPlacebo comparator0.5 ml Placebo on Day 0, 7 and 28
Receives: Biological: Placebo

What is being measured

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

  1. Rate of subjects with solicited adverse events including injection site and systemic reactions

    Measured: within 7 days after any vaccination

Secondary outcomes (24)

  1. Rate of subjects with solicited adverse events including injection site and systemic reactions

    Measured: within 7 days after each vaccination

  2. Rate of subjects with any adverse events (AEs)

    Measured: up to Day 56

  3. Rate of subjects with any adverse events (AEs)

    Measured: during the entire study period, i.e., up to Day 208

  4. Rate of subjects with serious adverse events (SAEs)

    Measured: up to Day 56

  5. Rate of subjects with serious adverse events (SAEs)

    Measured: up to Day 208

  6. Rate of subjects with any IMP-related AEs

    IMP: Investigational Medicinal Product;

    Measured: up to Day 56

  7. Rate of subjects with any IMP-related AEs

    IMP: Investigational Medicinal Product;

    Measured: up to Day 208

  8. Rate of subjects with any IMP-related SAEs

    IMP: Investigational Medicinal Product;

    Measured: up to Day 56

  9. Rate of subjects with any IMP-related SAEs

    IMP: Investigational Medicinal Product;

    Measured: up to Day 208

  10. Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination

    GMT determined by plaque reduction neutralization test (PRNT)

    Measured: 7 days after last active vaccination

  11. Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination

    GMT determined by plaque reduction neutralization test (PRNT)

    Measured: 28 days after last active vaccination

  12. GMT for ZIKV-specific neutralizing antibody titer after first vaccination

    GMT determined by PRNT

    Measured: 7 days after first vaccination

  13. GMT for ZIKV-specific neutralizing antibody titer after first vaccination

    for the Day 0, 28 schedule; GMT determined by PRNT

    Measured: 28 days after first vaccination

  14. GMT for ZIKV-specific neutralizing antibody titer after first vaccination

    GMT determined by PRNT

    Measured: Day 208 after first vaccination

  15. Rate of subjects with seroconversion after last active vaccination

    Measured: 7 days after last active vaccination

  16. Rate of subjects with seroconversion after last active vaccination

    Measured: 28 days after last active vaccination

  17. Rate of subjects with seroconversion after first vaccination

    Measured: 7 days after first vaccination

  18. Rate of subjects with seroconversion after first vaccination

    for the Day 0, 28 schedule

    Measured: 28 days after first vaccination

  19. Rate of subjects with seroconversion after first vaccination

    Measured: 208 days after first vaccination

  20. Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline

    Measured: 7 after last active vaccination

  21. Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline

    Measured: 28 after last active vaccination

  22. Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline

    Measured: 7 days after first vaccination

  23. Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline

    for the Day 0, 28 schedule

    Measured: 28 days after first vaccination

  24. Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline

    Measured: 208 days after first vaccination

Timeline

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

  1. First posted7 Feb 2018
  2. Study start24 Feb 2018
  3. Primary completion26 Jun 2018
  4. Study completion16 Nov 2018

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425149
Sponsor's protocol ID
VLA1601-101
Status last verified
Jul 2019
First submitted
23 Jan 2018
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VLA1601 in people with Zika Virus and Zika Virus Infection, run by Valneva Austria GmbH at 1 site 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 11 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: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Rate of subjects with solicited adverse events including injection site and systemic reactions (time frame: within 7 days after any vaccination). 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 NCT03425149.

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 5 Jul 2019.

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