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

NCT03425149 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VLA1601-101
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Zika Virus; Zika Virus Infection

Keywords

vaccine; prevention

Outcome Measures

Primary Outcomes (1)

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

  within 7 days after any vaccination

Secondary Outcomes (24)

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

  within 7 days after each vaccination

• Rate of subjects with any adverse events (AEs)

  up to Day 56

• Rate of subjects with any adverse events (AEs)

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

• Rate of subjects with serious adverse events (SAEs)

  up to Day 56

• Rate of subjects with serious adverse events (SAEs)

  up to Day 208

Study Arms (5)

Treatment Group I

EXPERIMENTAL

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

Biological: VLA1601; Biological: Placebo

Treatment Group II

EXPERIMENTAL

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

Biological: VLA1601; Biological: Placebo

Treatment Group III

EXPERIMENTAL

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

Biological: VLA1601; Biological: Placebo

Treatment Group IV

EXPERIMENTAL

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

Biological: VLA1601; Biological: Placebo

Treatment Group V

PLACEBO COMPARATOR

0.5 ml Placebo on Day 0, 7 and 28

Biological: Placebo

Interventions

VLA1601 BIOLOGICAL

purified inactivated ZIKV vaccine candidate adsorbed on alum

Treatment Group I; Treatment Group II; Treatment Group III; Treatment Group IV

Placebo BIOLOGICAL

Phosphate buffered saline (PBS)

Treatment Group I; Treatment Group II; Treatment Group III; Treatment Group IV; Treatment Group V

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Valneva Austria GmbH: lead
• Emergent BioSolutions: collaborator

Study Sites (1)

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Katrin Dubischar

  Valneva Austria GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: only dedicated site staff responsible for handling including preparation and administration of the vaccine will be unblinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 7, 2018
• Study Start: February 24, 2018
• Primary Completion: June 26, 2018
• Study Completion: November 16, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

US (1)