- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03425149
Randomized, Placebo-controlled, Observer-blinded Phase 1 Safety and Immunogenicity Study of Inactivated Zika Virus Vaccine Candidate in Healthy Adults
July 3, 2019 updated by: Valneva Austria GmbH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
- New Orleans Center for Clinical Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
purified inactivated ZIKV vaccine candidate adsorbed on alum
Phosphate buffered saline (PBS)
|
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
|
purified inactivated ZIKV vaccine candidate adsorbed on alum
Phosphate buffered saline (PBS)
|
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
|
purified inactivated ZIKV vaccine candidate adsorbed on alum
Phosphate buffered saline (PBS)
|
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
|
purified inactivated ZIKV vaccine candidate adsorbed on alum
Phosphate buffered saline (PBS)
|
Placebo Comparator: Treatment Group V
0.5 ml Placebo on Day 0, 7 and 28
|
Phosphate buffered saline (PBS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of subjects with solicited adverse events including injection site and systemic reactions
Time Frame: within 7 days after any vaccination
|
within 7 days after any vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of subjects with solicited adverse events including injection site and systemic reactions
Time Frame: within 7 days after each vaccination
|
within 7 days after each vaccination
|
|
Rate of subjects with any adverse events (AEs)
Time Frame: up to Day 56
|
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
|
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
|
up to Day 56
|
|
Rate of subjects with serious adverse events (SAEs)
Time Frame: up to Day 208
|
up to Day 208
|
|
Rate of subjects with any IMP-related AEs
Time Frame: up to Day 56
|
IMP: Investigational Medicinal Product;
|
up to Day 56
|
Rate of subjects with any IMP-related AEs
Time Frame: up to Day 208
|
IMP: Investigational Medicinal Product;
|
up to Day 208
|
Rate of subjects with any IMP-related SAEs
Time Frame: up to Day 56
|
IMP: Investigational Medicinal Product;
|
up to Day 56
|
Rate of subjects with any IMP-related SAEs
Time Frame: up to Day 208
|
IMP: Investigational Medicinal Product;
|
up to Day 208
|
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)
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7 days after last active vaccination
|
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)
|
28 days after last active vaccination
|
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
Time Frame: 7 days after first vaccination
|
GMT determined by PRNT
|
7 days after first vaccination
|
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
|
28 days after first vaccination
|
GMT for ZIKV-specific neutralizing antibody titer after first vaccination
Time Frame: Day 208 after first vaccination
|
GMT determined by PRNT
|
Day 208 after first vaccination
|
Rate of subjects with seroconversion after last active vaccination
Time Frame: 7 days after last active vaccination
|
7 days after last active vaccination
|
|
Rate of subjects with seroconversion after last active vaccination
Time Frame: 28 days after last active vaccination
|
28 days after last active vaccination
|
|
Rate of subjects with seroconversion after first vaccination
Time Frame: 7 days after first vaccination
|
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
|
28 days after first vaccination
|
Rate of subjects with seroconversion after first vaccination
Time Frame: 208 days after first vaccination
|
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
|
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
|
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
|
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
|
28 days after first vaccination
|
Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline
Time Frame: 208 days after first vaccination
|
208 days after first vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2018
Primary Completion (Actual)
June 26, 2018
Study Completion (Actual)
November 16, 2018
Study Registration Dates
First Submitted
January 23, 2018
First Submitted That Met QC Criteria
February 6, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 3, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLA1601-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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