Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425149
Other study ID # VLA1601-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 24, 2018
Est. completion date November 16, 2018

Study information

Verified date July 2019
Source Valneva Austria GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date November 16, 2018
Est. primary completion date June 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
VLA1601
purified inactivated ZIKV vaccine candidate adsorbed on alum
Placebo
Phosphate buffered saline (PBS)

Locations

Country Name City State
United States New Orleans Center for Clinical Research Knoxville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Valneva Austria GmbH Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of subjects with solicited adverse events including injection site and systemic reactions within 7 days after any vaccination
Secondary Rate of subjects with solicited adverse events including injection site and systemic reactions within 7 days after each vaccination
Secondary Rate of subjects with any adverse events (AEs) up to Day 56
Secondary Rate of subjects with any adverse events (AEs) during the entire study period, i.e., up to Day 208
Secondary Rate of subjects with serious adverse events (SAEs) up to Day 56
Secondary Rate of subjects with serious adverse events (SAEs) up to Day 208
Secondary Rate of subjects with any IMP-related AEs IMP: Investigational Medicinal Product; up to Day 56
Secondary Rate of subjects with any IMP-related AEs IMP: Investigational Medicinal Product; up to Day 208
Secondary Rate of subjects with any IMP-related SAEs IMP: Investigational Medicinal Product; up to Day 56
Secondary Rate of subjects with any IMP-related SAEs IMP: Investigational Medicinal Product; up to Day 208
Secondary Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination GMT determined by plaque reduction neutralization test (PRNT) 7 days after last active vaccination
Secondary Geometric mean titer (GMT) for ZIKV-specific neutralizing antibody titer after last active vaccination GMT determined by plaque reduction neutralization test (PRNT) 28 days after last active vaccination
Secondary GMT for ZIKV-specific neutralizing antibody titer after first vaccination GMT determined by PRNT 7 days after first vaccination
Secondary GMT for ZIKV-specific neutralizing antibody titer after first vaccination for the Day 0, 28 schedule; GMT determined by PRNT 28 days after first vaccination
Secondary GMT for ZIKV-specific neutralizing antibody titer after first vaccination GMT determined by PRNT Day 208 after first vaccination
Secondary Rate of subjects with seroconversion after last active vaccination 7 days after last active vaccination
Secondary Rate of subjects with seroconversion after last active vaccination 28 days after last active vaccination
Secondary Rate of subjects with seroconversion after first vaccination 7 days after first vaccination
Secondary Rate of subjects with seroconversion after first vaccination for the Day 0, 28 schedule 28 days after first vaccination
Secondary Rate of subjects with seroconversion after first vaccination 208 days after first vaccination
Secondary Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline 7 after last active vaccination
Secondary Fold increase of ZIKV-specific neutralizing antibody titers after last active vaccination as compared to baseline 28 after last active vaccination
Secondary Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline 7 days after first vaccination
Secondary Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline for the Day 0, 28 schedule 28 days after first vaccination
Secondary Fold increase of ZIKV-specific neutralizing antibody titers after first vaccination as compared to baseline 208 days after first vaccination
See also
  Status Clinical Trial Phase
Completed NCT04697147 - Zika and Neurodevelopment Among Infants in Grenada N/A
Completed NCT03631719 - Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
Completed NCT02952833 - ZIKA Vaccine in Naive Subjects Phase 1
Terminated NCT03055585 - Applying Wolbachia to Eliminate Dengue N/A
Not yet recruiting NCT05589012 - Evaluation of Viral Replication by Tonate Virus (TONV) and Zika Virus (ZIKV), Within an ex Vivo Trophoblast and Placental Model
Completed NCT02963909 - A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects. Phase 1
Completed NCT03110770 - VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents Phase 2
Recruiting NCT06334393 - Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults Phase 1
Completed NCT03008122 - Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area Phase 1
Terminated NCT03161444 - Estimated Cumulative Incidence of Zika Infection at the End of the First Epidemic in the French West Indies in a Sample of Patients Followed for HIV Infection. N/A
Completed NCT04478656 - Safety and Immunogenicity of BBV121 Phase 1
Completed NCT03624946 - Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) Phase 1
Completed NCT03330600 - Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome N/A
Completed NCT05041439 - Adherence to Care for Children With Congenital Zika Virus Infection in Puerto Rico N/A
Recruiting NCT03255369 - Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF)
Completed NCT03206541 - Neurologic Manifestations of the Arbovirus Infection in Colombia
Completed NCT04033068 - Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) Phase 1
Completed NCT03679728 - Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
Withdrawn NCT03204409 - ZIKAlliance Natural History Study
Completed NCT03776903 - Evaluation of the Clinical Performance of the ZIKV Detect™ 2.0 IgM Capture ELISA