Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus
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ClinicalTrials.gov Identifier: NCT04519073 |
Recruitment Status :
Completed
First Posted : August 19, 2020
Last Update Posted : March 7, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | August 15, 2020 | ||||
First Posted Date ICMJE | August 19, 2020 | ||||
Last Update Posted Date | March 7, 2022 | ||||
Actual Study Start Date ICMJE | September 7, 2020 | ||||
Actual Primary Completion Date | March 2, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Humoral immune response [ Time Frame: Day 0 to Month 12 ] RSV micro-neutralization titers against RSV A and B.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus | ||||
Official Title ICMJE | Randomized, Placebo-controlled, Double-blind, Phase 1, Dose-escalating Study to Evaluate the Safety and Immunogenicity of a Synthetic Virus Like Particle (SVLP) Vaccine Against Respiratory Syncytial Virus (RSV) | ||||
Brief Summary | The primary and secondary objectives of this Phase 1 study are respectively to assess the safety and the immunogenicity of two administrations of the RSV vaccine candidate at three different doses. The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg, n=15), intermediate (50 µg, n=15) or high dosage (150 µg, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years. There will be two phases: an active treatment phase from Day 0 to Month 3, and a follow-up phase from Month 3 + 1 day to Month 12. During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration. Blood will be drawn at a screening visit and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84. During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit. Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84. The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months. |
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Detailed Description | Virometix designed and developed a candidate vaccine coded V-306 based on synthetic virus like particles (SVLP) that present the neutralizing Palivizumab epitope of the antigenic site II region of the F-protein (FsII). V-306 has been evaluated in cotton rats, mice and rabbits for safety and immunogenicity. Strong immunogenicity was demonstrated in mice and rabbits by ELISA and RSV A and B neutralization. Full protection with no vaccine-associated enhanced respiratory disease (VAERD) was demonstrated in a validated mouse challenge model. Reduction of the viral load with no VAERD was also shown in the cotton rat challenge model. The primary objective of the first-in-human Phase 1 study is to assess the safety of two administrations of the RSV vaccine candidate at three different dosages of V-306. The secondary objective is to assess the immunogenicity of two administrations of the RSV vaccine candidate at three different dosages of V-306. The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. It will be conducted in one centre. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg/administration, n=15), intermediate (50 µg/administration, n=15) or high dosage (150 µg/administration, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years. The enrolment schedule with sentinel dosing will be the same in each cohort. After each administration, the subject will be observed in the clinical trial centre for 120 minutes, before being discharged. The study will be in two phases: (1) an active treatment phase from Day 0 to Month 3, i.e. one month post 2nd administration, with unblinding and primary analysis of data collected up to Month 3, and (2) a follow-up phase from Month 3 + 1 day to Month 12 post-1st administration for safety and immunogenicity. The sponsor will be unblinded at Month 3, while the clinical site and laboratory will remain blinded during the whole study. During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration. A time window will be defined for each visit. Blood will be drawn at a screening visit (up to 14 days before Day 0 for lab safety analyses and up to 2 months before Day 0 for serology analyses) and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. These data will be part of the baseline health status of each subject. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample and if positive will be confirmed by blood analysis. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84. During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit. Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Months 6, 9 and 12 aim to evaluate the persistence of the humoral response. Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84. Data collection will use an electronic Case Report Form (eCRF). The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) study in one centre. Masking: Double (Participant, Investigator)Masking Description: The Investigator, the laboratory and the subjects will be kept blind to the treatment arm (placebo/vaccine) to which the subject has been allocated up to the end of the study (Month 12). Primary Purpose: Prevention
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Condition ICMJE | Acute Bronchiolitis Due to Respiratory Syncytial Virus | ||||
Intervention ICMJE | Biological: V-306 candidate vaccine
Each V-306 monomer consists of the following elements:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 2, 2022 | ||||
Actual Primary Completion Date | March 2, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04519073 | ||||
Other Study ID Numbers ICMJE | VMXRSV306-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Virometix | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Virometix | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Virometix | ||||
Verification Date | March 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |