Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03425149
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Emergent BioSolutions
Information provided by (Responsible Party):
Valneva Austria GmbH

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE February 24, 2018
Actual Primary Completion Date June 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Rate of subjects with solicited adverse events including injection site and systemic reactions [ Time Frame: within 7 days after any vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Rate of subjects with solicited adverse events including injection site and systemic reactions [ Time Frame: within 7 days after each vaccination ]
  • Rate of subjects with any adverse events (AEs) [ Time Frame: up to Day 56 ]
  • Rate of subjects with any adverse events (AEs) [ Time Frame: during the entire study period, i.e., up to Day 208 ]
  • Rate of subjects with serious adverse events (SAEs) [ Time Frame: up to Day 56 ]
  • Rate of subjects with serious adverse events (SAEs) [ Time Frame: up to Day 208 ]
  • Rate of subjects with any IMP-related AEs [ Time Frame: up to Day 56 ]
    IMP: Investigational Medicinal Product;
  • Rate of subjects with any IMP-related AEs [ Time Frame: up to Day 208 ]
    IMP: Investigational Medicinal Product;
  • Rate of subjects with any IMP-related SAEs [ Time Frame: up to Day 56 ]
    IMP: Investigational Medicinal Product;
  • Rate of subjects with any IMP-related SAEs [ Time Frame: up to Day 208 ]
    IMP: Investigational Medicinal Product;
  • Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination [ Time Frame: 7 days after last active vaccination ]
    GMT determined by plaque reduction neutralization test (PRNT)
  • Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination [ Time Frame: 28 days after last active vaccination ]
    GMT determined by plaque reduction neutralization test (PRNT)
  • GMT for ZIKV-specific neutralizing antibody titer after first vaccination [ Time Frame: 7 days after first vaccination ]
    GMT determined by PRNT
  • GMT for ZIKV-specific neutralizing antibody titer after first vaccination [ Time Frame: 28 days after first vaccination ]
    for the Day 0, 28 schedule; GMT determined by PRNT
  • GMT for ZIKV-specific neutralizing antibody titer after first vaccination [ Time Frame: Day 208 after first vaccination ]
    GMT determined by PRNT
  • Rate of subjects with seroconversion after last active vaccination [ Time Frame: 7 days after last active vaccination ]
  • Rate of subjects with seroconversion after last active vaccination [ Time Frame: 28 days after last active vaccination ]
  • Rate of subjects with seroconversion after first vaccination [ Time Frame: 7 days after first vaccination ]
  • Rate of subjects with seroconversion after first vaccination [ Time Frame: 28 days after first vaccination ]
    for the Day 0, 28 schedule
  • Rate of subjects with seroconversion after first vaccination [ Time Frame: 208 days after first vaccination ]
  • Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline [ Time Frame: 7 after last active vaccination ]
  • Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline [ Time Frame: 28 after last active vaccination ]
  • Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline [ Time Frame: 7 days after first vaccination ]
  • Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline [ Time Frame: 28 days after first vaccination ]
    for the Day 0, 28 schedule
  • Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline [ Time Frame: 208 days after first vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
Official Title  ICMJE 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
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
only dedicated site staff responsible for handling including preparation and administration of the vaccine will be unblinded
Primary Purpose: Prevention
Condition  ICMJE
  • Zika Virus
  • Zika Virus Infection
Intervention  ICMJE
  • Biological: VLA1601
    purified inactivated ZIKV vaccine candidate adsorbed on alum
  • Biological: Placebo
    Phosphate buffered saline (PBS)
Study Arms  ICMJE
  • Experimental: Treatment Group I
    0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7
    Interventions:
    • Biological: VLA1601
    • Biological: Placebo
  • Experimental: Treatment Group II
    0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28
    Interventions:
    • Biological: VLA1601
    • Biological: Placebo
  • Experimental: Treatment Group III
    0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7
    Interventions:
    • Biological: VLA1601
    • Biological: Placebo
  • Experimental: Treatment Group IV
    0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28
    Interventions:
    • Biological: VLA1601
    • Biological: Placebo
  • Placebo Comparator: Treatment Group V
    0.5 ml Placebo on Day 0, 7 and 28
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2018)
67
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 16, 2018
Actual Primary Completion Date June 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is 18 to 49 years of age on the day of screening (Visit 0);
  2. Subject has a Body Mass Index (BMI) of ≥18.5 and <30 kg/m2 on the day of screening (Visit 0);
  3. 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;
  4. Subject is generally healthy as determined by the Investigator's clinical judgment based on medical history, physical examination and screening laboratory tests;
  5. If subject is of childbearing potential:

    i. Subject has a negative serum pregnancy test at screening (Visit 0);

ii. Subject agrees to employ adequate birth control measures for the duration of the study. This includes one of the following measures:

  1. Hormonal contraceptives (e.g. implants, birth control pills, patches) since ≥30 days prior to first vaccination;
  2. Intrauterine device;
  3. Barrier type of birth control measure (e.g. condoms, diaphragms, cervical caps);
  4. Vasectomy in the male sex partner ≥3 months prior to first vaccination;

Exclusion Criteria:

  1. Subject has a history of known flavivirus infection, or vaccination with a licensed or investigational flavivirus vaccine;
  2. Subject has plans to receive a licensed flavivirus vaccine during the course of the study;
  3. 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;
  4. Subject is seropositive to ZIKV, JEV, DENV or West Nile virus (WNV);
  5. Subject has received an inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to vaccination in this study;
  6. Subject has clinically significant abnormal laboratory values, as determined by the Investigator, at screening (Visit 0);
  7. Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
  8. 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;
  9. 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);
  10. Subject has a history of severe hypersensitivity reactions or anaphylaxis;
  11. Subject has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications);
  12. Subject had acute febrile infections within two weeks prior to vaccination in this study;
  13. 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;
  14. Subject has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating;
  15. 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;
  16. 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;
  17. Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
  18. Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
  19. 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;
  20. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03425149
Other Study ID Numbers  ICMJE VLA1601-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valneva Austria GmbH
Study Sponsor  ICMJE Valneva Austria GmbH
Collaborators  ICMJE Emergent BioSolutions
Investigators  ICMJE
Study Director: Katrin Dubischar Valneva Austria GmbH
PRS Account Valneva Austria GmbH
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP