Zika Virus Infection Clinical 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
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 28, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | Key Inclusion 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. Key Exclusion Criteria: Participant - 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 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]), 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. |
Country | Name | City | State |
---|---|---|---|
United States | Flourish Research | Chicago | Illinois |
United States | Velocity Clinical Research | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Valneva Austria GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Solicited Adverse Events | frequency of solicited AEs (injection site and systemic reactions) | 7 days after each vaccination | |
Primary | Solicited Adverse Events | severity of solicited AEs (injection site and systemic reactions) | 7 days after each vaccination | |
Primary | Neutralizing antibodies against ZIKA virus (ZIKV) | Geometric mean titer (GMT) for neutralizing antibodies against (ZIKV) determined by virus neutralization assay | Day 57 | |
Secondary | Solicited Adverse Events | frequency of solicited AEs (injection site and systemic reactions) | 7 days after any vaccination | |
Secondary | Solicited Adverse Events | severity of solicited AEs (injection site and systemic reactions) | 7 days after any vaccination | |
Secondary | Unsolicited AEs | frequency of unsolicited AEs | Day 57 | |
Secondary | Unsolicited AEs | severity of unsolicited AEs | Day 57 | |
Secondary | Vaccine-related unsolicited AEs | frequency of vaccine-related unsolicited AEs | Day 57 | |
Secondary | Vaccine-related unsolicited AEs | severity of vaccine-related unsolicited AEs | Day 57 | |
Secondary | Any AEs | severity of any AEs (including solicited and unsolicited AEs) | Day 395 | |
Secondary | Any AEs | frequency of any AEs (including solicited and unsolicited AEs) | Day 395 | |
Secondary | any vaccine-related AEs | severity of any vaccine-related AEs (including solicited and unsolicited AEs) | Day 395 | |
Secondary | Vaccine-related unsolicited AEs | frequency of vaccine-related AEs (including solicited and unsolicited AEs) | Day 395 | |
Secondary | Adverse Events of Special Interest (AESI) | severity of AESI | Day 395 | |
Secondary | Adverse Events of Special Interest (AESI) | frequency of AESI | Day 395 | |
Secondary | Vaccine-related Adverse Events of Special Interest (AESI) | frequency of vaccine-related AESI | Day 395 | |
Secondary | Vaccine-related Adverse Events of Special Interest (AESI) | severity of vaccine-related AESI | Day 395 | |
Secondary | Serious Adverse Events (SAE) | frequency of SAEs | Day 395 | |
Secondary | Serious Adverse Events (SAE) | severity of SAEs | Day 395 | |
Secondary | Vaccine-related Serious Adverse Events (SAE) | frequency of vaccine-related SAEs | Day 395 | |
Secondary | Vaccine-related Serious Adverse Events (SAE) | severity of vaccine-related SAEs | Day 395 | |
Secondary | ZIKV-specific neutralizing antibodies | Geometric Mean Titer (GMT) as determined by virus neutralization assay | up to Day 395 (including Day 1, 15, 29, 43, 208) | |
Secondary | Seroconversion rate (SCR) | Rate of participants with seroconversion (cut-off of ZIKV-specific neutralizing antibody titer to be determined) compared to baseline determined by virus neutralization assay | up to Day 395 (including Day 1, 15, 29, 43, 208) | |
Secondary | Geometric Mean Fold Increase (GMFI) | Geometric Mean Fold Increase compared to baseline determined by virus neutralization assay | up to Day 395 (including Day 1, 15, 29, 43, 208) |
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