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

• ClinicalTrials.gov Identifier: NCT04786444
• Recruitment Status: Completed
• First Posted: March 8, 2021
• Last Update Posted: February 1, 2022
• Sponsor: Valneva Austria GmbH
• Information provided by (Responsible Party): Valneva Austria GmbH

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 409 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
• Actual Primary Completion Date: July 22, 2021
• Actual Study Completion Date: January 26, 2022

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Florida

AMR Miami

Coral Gables, Florida, United States, 33134

AMR Fort Myers

Fort Myers, Florida, United States, 33912

St. Johns Center for Clinical Research

Ponte Vedra, Florida, United States, 32081

United States, Kansas

AMR Wichita West

Wichita, Kansas, United States, 67205

United States, Kentucky

AMR Lexington

Lexington, Kentucky, United States, 40509

United States, Maryland

Walter Reed Amy Institute of Research

Silver Spring, Maryland, United States, 20910

United States, Missouri

Alliance for Multispecialty Research (AMR)

Kansas City, Missouri, United States, 64114

United States, Nebraska

Meridian Clinical Research

Omaha, Nebraska, United States, 68134

United States, Nevada

Wr-Crcn, Llc

Las Vegas, Nevada, United States, 89104

United States, New York

Rochester Clinical Research

Rochester, New York, United States, 14609

United States, Tennessee

AMR Knoxville

Knoxville, Tennessee, United States, 37919

United States, Texas

Dynamed Clinical Research

Tomball, Texas, United States, 77375

Sponsors and Collaborators

Valneva Austria GmbH

Investigators

• Study Chair: Valneva Clinical Development; Valneva Austria GmbH

More Information

• Responsible Party: Valneva Austria GmbH
• ClinicalTrials.gov Identifier: NCT04786444
• Other Study ID Numbers: VLA1553-302
• First Posted: March 8, 2021
• Last Update Posted: February 1, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Virus Diseases; Chikungunya Fever; Infections; Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Togaviridae Infections; RNA Virus Infections