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

Primary Purpose

Zika Virus, Zika Virus Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VLA1601
Placebo
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Zika Virus focused on measuring vaccine, prevention

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New Orleans Center for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment Group I

Treatment Group II

Treatment Group III

Treatment Group IV

Treatment Group V

Arm Description

0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7

0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28

0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7

0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28

0.5 ml Placebo on Day 0, 7 and 28

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of subjects with solicited adverse events including injection site and systemic reactions
Rate of subjects with any adverse events (AEs)
Rate of subjects with any adverse events (AEs)
Rate of subjects with serious adverse events (SAEs)
Rate of subjects with serious adverse events (SAEs)
Rate of subjects with any IMP-related AEs
IMP: Investigational Medicinal Product;
Rate of subjects with any IMP-related AEs
IMP: Investigational Medicinal Product;
Rate of subjects with any IMP-related SAEs
IMP: Investigational Medicinal Product;
Rate of subjects with any IMP-related SAEs
IMP: Investigational Medicinal Product;
Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer 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
GMT determined by plaque reduction neutralization test (PRNT)
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
GMT determined by PRNT
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
for the Day 0, 28 schedule; GMT determined by PRNT
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
GMT determined by PRNT
Rate of subjects with seroconversion after last active vaccination
Rate of subjects with seroconversion after last active vaccination
Rate of subjects with seroconversion after first vaccination
Rate of subjects with seroconversion after first vaccination
for the Day 0, 28 schedule
Rate of subjects with seroconversion after first vaccination
Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline
Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
for the Day 0, 28 schedule
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline

Full Information

First Posted
January 23, 2018
Last Updated
July 3, 2019
Sponsor
Valneva Austria GmbH
Collaborators
Emergent BioSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT03425149
Brief Title
Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 24, 2018 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)

3. Sponsor/Collaborators

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

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus, Zika Virus Infection
Keywords
vaccine, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
only dedicated site staff responsible for handling including preparation and administration of the vaccine will be unblinded
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group I
Arm Type
Experimental
Arm Description
0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.5 ml Placebo on Day 7
Arm Title
Treatment Group II
Arm Type
Experimental
Arm Description
0.5 ml (6 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.5 ml Placebo on Day 28
Arm Title
Treatment Group III
Arm Type
Experimental
Arm Description
0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 28, 0.25 ml Placebo on Day 7
Arm Title
Treatment Group IV
Arm Type
Experimental
Arm Description
0.25 ml (3 antigen units (AU)) of VLA1601 on Day 0 and 7, 0.25 ml Placebo on Day 28
Arm Title
Treatment Group V
Arm Type
Placebo Comparator
Arm Description
0.5 ml Placebo on Day 0, 7 and 28
Intervention Type
Biological
Intervention Name(s)
VLA1601
Intervention Description
purified inactivated ZIKV vaccine candidate adsorbed on alum
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Phosphate buffered saline (PBS)
Primary Outcome Measure Information:
Title
Rate of subjects with solicited adverse events including injection site and systemic reactions
Time Frame
within 7 days after any vaccination
Secondary Outcome Measure Information:
Title
Rate of subjects with solicited adverse events including injection site and systemic reactions
Time Frame
within 7 days after each vaccination
Title
Rate of subjects with any adverse events (AEs)
Time Frame
up to Day 56
Title
Rate of subjects with any adverse events (AEs)
Time Frame
during the entire study period, i.e., up to Day 208
Title
Rate of subjects with serious adverse events (SAEs)
Time Frame
up to Day 56
Title
Rate of subjects with serious adverse events (SAEs)
Time Frame
up to Day 208
Title
Rate of subjects with any IMP-related AEs
Description
IMP: Investigational Medicinal Product;
Time Frame
up to Day 56
Title
Rate of subjects with any IMP-related AEs
Description
IMP: Investigational Medicinal Product;
Time Frame
up to Day 208
Title
Rate of subjects with any IMP-related SAEs
Description
IMP: Investigational Medicinal Product;
Time Frame
up to Day 56
Title
Rate of subjects with any IMP-related SAEs
Description
IMP: Investigational Medicinal Product;
Time Frame
up to Day 208
Title
Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination
Description
GMT determined by plaque reduction neutralization test (PRNT)
Time Frame
7 days after last active vaccination
Title
Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination
Description
GMT determined by plaque reduction neutralization test (PRNT)
Time Frame
28 days after last active vaccination
Title
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
Description
GMT determined by PRNT
Time Frame
7 days after first vaccination
Title
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
Description
for the Day 0, 28 schedule; GMT determined by PRNT
Time Frame
28 days after first vaccination
Title
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
Description
GMT determined by PRNT
Time Frame
Day 208 after first vaccination
Title
Rate of subjects with seroconversion after last active vaccination
Time Frame
7 days after last active vaccination
Title
Rate of subjects with seroconversion after last active vaccination
Time Frame
28 days after last active vaccination
Title
Rate of subjects with seroconversion after first vaccination
Time Frame
7 days after first vaccination
Title
Rate of subjects with seroconversion after first vaccination
Description
for the Day 0, 28 schedule
Time Frame
28 days after first vaccination
Title
Rate of subjects with seroconversion after first vaccination
Time Frame
208 days after first vaccination
Title
Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline
Time Frame
7 after last active vaccination
Title
Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline
Time Frame
28 after last active vaccination
Title
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
Time Frame
7 days after first vaccination
Title
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
Description
for the Day 0, 28 schedule
Time Frame
28 days after first vaccination
Title
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
Time Frame
208 days after first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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: 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; Exclusion Criteria: 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); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Dubischar
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
Facility Information:
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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