ACTIVE_NOT_RECRUITING

Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults

Conditions

Zika Zika Virus Infection vaccine Phase 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29). The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immune response of the vaccine candidate will be monitored throughout the trial.

Official Title

A Phase 1 Double-blind, Randomized, Dose Finding Clinical Trial with an Open-label Run-in Part to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years

Quick Facts

Study Start:2024-03-25

Study Completion:2026-04-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06334393

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.

Ages Eligible for Study:18 Years to 49 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 18 to 49 years of age * BMI of ≥18.5 and \<30 kg/m2 * generally healthy as determined by the investigator's clinical judgement based on medical history, physical examination, and screening laboratory tests. * If trial participant is of childbearing potential: negative pregnancy test; employ adequate birth control measures up to Day 208. * Male participant agrees to employ adequate birth control measures up to 90 days after last vaccination.	* has a known history of the following flavivirus infection: Zika Virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV), Yellow Fever Virus (YFV), West-Nile Virus (WNV), or Tick-Borne Encephalitis Virus (TBEV). * received or has plans to receive a licensed or investigational flavivirus vaccine during the course of the trial. * travelled within 4 weeks prior to trial enrollment or has plans to travel to areas (including within the US) with Zika virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) active transmission/circulation during the course of the trial . * received active or passive immunization within 4 weeks prior or planned to get such vaccination after any trial-vaccination. * presents with clinically significant abnormal laboratory values, as determined by the investigator. * tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). * has history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barre syndrome \[GBS\]), psychiatric, hepatic, rheumatic, autoimmune, hematological, gastrointestinal, or renal disorder. * with known or suspected defect of the immune system that would prevent an immune response to the vaccine. * received immuno-suppressive therapy within 4 weeks prior to first vaccination. Radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years. * with a history of severe hypersensitivity reactions or anaphylaxis. * with a history of any vaccine related contraindicating event . * with acute febrile infections within two weeks prior to vaccination in this trial. * donated blood within 4 weeks or received blood-derived products (e.g. plasma) within 12 weeks prior to vaccination in this trial or plans to donate blood or use blood products during the course of the trial. * has a rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection site reaction rating. * presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * is currently enrolled (ICF signed) or has participated in another clinical trial involving an investigational medicinal product (IMP) or device within 4 weeks prior to trial enrollment or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial. * has a known or suspected problem with alcohol or drug abuse

Inclusion Criteria

Exclusion Criteria

* 18 to 49 years of age
* BMI of ≥18.5 and \<30 kg/m2
* generally healthy as determined by the investigator's clinical judgement based on medical history, physical examination, and screening laboratory tests.
* If trial participant is of childbearing potential: negative pregnancy test; employ adequate birth control measures up to Day 208.
* Male participant agrees to employ adequate birth control measures up to 90 days after last vaccination.

* has a known history of the following flavivirus infection: Zika Virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV), Yellow Fever Virus (YFV), West-Nile Virus (WNV), or Tick-Borne Encephalitis Virus (TBEV).
* received or has plans to receive a licensed or investigational flavivirus vaccine during the course of the trial.
* travelled within 4 weeks prior to trial enrollment or has plans to travel to areas (including within the US) with Zika virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) active transmission/circulation during the course of the trial .
* received active or passive immunization within 4 weeks prior or planned to get such vaccination after any trial-vaccination.
* presents with clinically significant abnormal laboratory values, as determined by the investigator.
* tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
* has history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barre syndrome \[GBS\]), psychiatric, hepatic, rheumatic, autoimmune, hematological, gastrointestinal, or renal disorder.
* with known or suspected defect of the immune system that would prevent an immune response to the vaccine.
* received immuno-suppressive therapy within 4 weeks prior to first vaccination. Radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years.
* with a history of severe hypersensitivity reactions or anaphylaxis.
* with a history of any vaccine related contraindicating event .
* with acute febrile infections within two weeks prior to vaccination in this trial.
* donated blood within 4 weeks or received blood-derived products (e.g. plasma) within 12 weeks prior to vaccination in this trial or plans to donate blood or use blood products during the course of the trial.
* has a rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection site reaction rating.
* presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* is currently enrolled (ICF signed) or has participated in another clinical trial involving an investigational medicinal product (IMP) or device within 4 weeks prior to trial enrollment or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial.
* has a known or suspected problem with alcohol or drug abuse

Contacts and Locations

Study Locations (Sites)

Flourish Research

Chicago, Illinois, 60640

United States

Velocity Clinical Research

Sioux City, Iowa, 51106

United States

Velocity Clinical Research

Lincoln, Nebraska, 68510

United States

Velocity Clinical Research

Omaha, Nebraska, 68134

United States

Collaborators and Investigators

Sponsor: Valneva Austria GmbH

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 Registration Dates

Study Start Date2024-03-25

Study Completion Date2026-04-27

Study Record Updates

Study Start Date2024-03-25

Study Completion Date2026-04-27

Terms related to this study

Keywords Provided by Researchers

vaccine
Phase 1

Additional Relevant MeSH Terms

Zika
Zika Virus Infection