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Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04786444
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Brief Summary:
This is a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall, approximately 402 healthy subjects aged 18 to 45 years will be enrolled into the study, approximately 134 subjects per VLA1553 Lot.

Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Biological: Biological Vaccine VLA1553 Phase 3

Detailed Description:
This is a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553. Overall, approximately 402 healthy subjects aged 18 to 45 years will be enrolled into the study, approximately 134 subjects per VLA1553 Lot. Subjects will be block-randomized in a 1:1:1 ratio into the three study arms to receive one of three Lots of VLA1553 as a single i.m. vaccination. The primary objective is to demonstrate Lot-to-Lot manufacturing consistency of VLA1553 28 days following vaccination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded Phase 3 Study to Demonstrate Lot-to-Lot Consistency of Three Lots of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Adults Aged 18 to 45 Years
Actual Study Start Date : February 22, 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Active Comparator: VLA1553 Lot 1 Biological: Biological Vaccine VLA1553
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Active Comparator: VLA1553 Lot 2 Biological: Biological Vaccine VLA1553
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Active Comparator: VLA1553 Lot 3 Biological: Biological Vaccine VLA1553
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate




Primary Outcome Measures :
  1. Geometric mean titer (GMT) of CHIKV-specific neutralizing antibodies as determined by microneutralization (μPRNT) assay in subjects who tested negative for CHIKV antibodies at baseline [ Time Frame: up to Day 29 after single vaccination ]

Secondary Outcome Measures :
  1. Immune response as measured by CHIKV-specific neutralizing antibody titers [ Time Frame: on Day 8, 85 and Month 6 ]
  2. Proportion of subjects with seroprotective levels for baseline negative subjects [ Time Frame: on Day 8, 29, 85 and Month 6 ]
  3. Proportion of subjects with seroconversion [ Time Frame: on Day 29 and Month 6 ]
  4. Fold increase of CHIKV-specific neutralizing antibody titers compared to baseline [ Time Frame: on Day 8, 29, 85 and Month 6 ]
  5. Proportion of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline [ Time Frame: up to Month 6 ]
  6. Frequency and severity of solicited injection site and systemic reactions [ Time Frame: 10 days post vaccination ]
  7. Frequency and severity of unsolicited adverse events (AEs) within 28 days post-vaccination [ Time Frame: up to Day 29 ]
  8. Frequency and severity of any Adverse Event during the entire study period [ Time Frame: up to Month 6 ]
  9. Frequency and severity of any Serious Adverse Event (SAE) during the entire study period [ Time Frame: up to Month 6 ]
  10. Frequency and severity of any Adverse Event of Special Interest (AESI) within 2 to 21 days post-vaccination [ Time Frame: up to Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 to 45 years of age on the Day of screening
  2. able to provide informed consent
  3. generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests
  4. for women of childbearing potential:

    1. practiced an adequate method of contraception during 30 days before screening
    2. negative serum or urine pregnancy test at screening or vaccination, respectively
    3. agrees to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85).

Exclusion Criteria:

  1. CHIKV infection in the past (self-reported), including suspected CHIKV infection; is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical study involving an investigational CHIKV vaccine
  2. acute or recent infection (and not symptom-free in the week prior to screening)
  3. tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
  4. received another live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively
  5. abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study
  6. medical history of or currently has acute or progressive, unstable or uncontrolled clinical conditions that pose a risk for participation in the study
  7. history of immune-mediated or clinically relevant arthritis / arthralgia
  8. history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the subject may be enrolled.
  9. known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination.
  10. history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications)
  11. clinical conditions representing a contraindication to intramuscular vaccination and blood draws
  12. pregnant, plans to become pregnant during the first three months post-vaccination or lactating at the time of enrollment
  13. Donated of blood, blood fractions or plasma 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 until Day 180 of the study
  14. rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
  15. known or suspected problem with alcohol or drug abuse as determined by the Investigator
  16. any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
  17. committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
  18. Participation 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 device during the course of this study
  19. member of the team conducting the study or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786444


Contacts
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Contact: Valneva Clinical Development +43 1 206 20 ext 0 office@valneva.com

Locations
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United States, Florida
AMR Miami Recruiting
Coral Gables, Florida, United States, 33134
Contact: Jeffrey Rosen         
AMR Fort Myers Recruiting
Fort Myers, Florida, United States, 33912
Contact: Pedro Ylisastigui         
St. Johns Center for Clinical Research Recruiting
Ponte Vedra, Florida, United States, 32081
Contact: Richard Myers         
United States, Kansas
AMR Wichita West Recruiting
Wichita, Kansas, United States, 67205
Contact: Richard Egelhof         
United States, Kentucky
AMR Lexington Recruiting
Lexington, Kentucky, United States, 40509
Contact: Mark Adams         
United States, Maryland
Walter Reed Amy Institute of Research Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Michael Koren, Dr.         
United States, Missouri
Alliance for Multispecialty Research (AMR) Recruiting
Kansas City, Missouri, United States, 64114
Contact: John Ervin         
United States, Nebraska
Meridian Clinical Research Recruiting
Omaha, Nebraska, United States, 68134
Contact: Brandon Essink         
United States, Nevada
Wr-Crcn, Llc Recruiting
Las Vegas, Nevada, United States, 89104
Contact: Michael Levin         
United States, New York
Rochester Clinical Research Recruiting
Rochester, New York, United States, 14609
Contact: Matthew Davis         
United States, Tennessee
AMR Knoxville Recruiting
Knoxville, Tennessee, United States, 37919
United States, Texas
Dynamed Clinical Research Recruiting
Tomball, Texas, United States, 77375
Contact: Earl Martin         
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
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Study Chair: Valneva Clinical Development Valneva Austria GmbH
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Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04786444    
Other Study ID Numbers: VLA1553-302
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valneva Austria GmbH:
VLA1553
Chikungunya Virus Infection
CHIKV
Live-attenuated Chikungunya virus vaccine
Additional relevant MeSH terms:
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Virus Diseases
Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections