Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04519073 |
Recruitment Status :
Completed
First Posted : August 19, 2020
Last Update Posted : March 7, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Bronchiolitis Due to Respiratory Syncytial Virus | Biological: V-306 candidate vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
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 |
Official Title: | 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) |
Actual Study Start Date : | September 7, 2020 |
Actual Primary Completion Date : | March 2, 2022 |
Actual Study Completion Date : | March 2, 2022 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
0.5 mL of diluent (phosphate buffer)
|
Biological: V-306 candidate vaccine
Each V-306 monomer consists of the following elements:
|
Experimental: V-306 low dose
V-306 at 15 µg
|
Biological: V-306 candidate vaccine
Each V-306 monomer consists of the following elements:
|
Experimental: V-306 intermediate dose
V-306 at 50 µg
|
Biological: V-306 candidate vaccine
Each V-306 monomer consists of the following elements:
|
Experimental: V-306 high dose
V-306 at 150 µg
|
Biological: V-306 candidate vaccine
Each V-306 monomer consists of the following elements:
|
- Solicited local and general adverse events [ Time Frame: During 7 days post-each administration ]Number and percentage of subjects reporting solicited local and general AEs reported on diary card during 7 days post-each administration in the placebo group and in the three vaccine cohorts. Local solicited symptoms are pain, induration, erythema, and swelling at administration site. General solicited symptoms are headache, fatigue, body temperature (measured orally) and generalized myalgia.
- Adverse events of special interest (AESI) [ Time Frame: Day 0 to Month 12 ]Number and percentage of subjects reporting AESI in the placebo group and in the three vaccine cohorts. Monitoring of AESI will include lower respiratory tract infection (LRTI) and respiratory events such as dyspnoea, wheezing, cough, other asthmatic symptoms and increased sputum production.
- Serious adverse events [ Time Frame: Day 0 to Month 12 ]Number and percentage of subjects reporting serious adverse events in the placebo group and in the three vaccine cohorts.
- Humoral immune response [ Time Frame: Day 0 to Month 12 ]RSV micro-neutralization titers against RSV A and B.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Written informed consent.
- Healthy women aged between 18-45 years.
- No evidence of disease based on medical history, physical examination, vital signs (blood pressure, heart rate, body temperature and respiratory rate), laboratory safety parameters and clinical judgement.
- Not pregnant and committed to not becoming pregnant during the whole study period. Committed to use adequate and effective contraception means in accordance with the Clinical Trial Facilitation Group (CTFG) criteria.
- The subjects must have used adequate and effective contraception means (CTFG criteria) for at least 60 days prior to the 1st administration.
- Capability to meet the requirements of the study.
Exclusion Criteria:
- Presence of serologic markers of acute or chronic Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAg and anti-HBc) and Hepatitis C Virus (anti-HCV) infection(s).
- As judged by the Investigator, any clinically significant disease related to the cardiovascular (CV), gastrointestinal (GI) or central nervous system (CNS).
- Any chronic disease, or history of significant disease that might interfere with the trial's conduct or completion. Some conditions may be accepted if stabilised, e.g. hypertension.
- An active respiratory disease or symptoms thereof (chronic obstructive pulmonary disease, asthma, asthmatic bronchitis, dyspnoea, wheezing, severe allergy) requiring medication, or history of such disease.
- Personal history of active or past autoimmune disease
- Administration for more than three months prior of study start of immunosuppressant or immuno-modifying drugs (including systemic corticosteroids).
- Confirmed or suspected (at the discretion of the Investigator) immuno-suppressive or immuno-deficient condition.
- Current smokers (more than 10 cigarettes/day).
- Blood transfusion, blood product, immunoglobulins received during the period of 3 months prior to study start.
- Clinically significant (according to Investigator's judgement) laboratory out of range values. The abnormal lab test can be neglected if its cause is evident and of no clinical relevance
- Acute disease and/or fever (≥38°C measured by the oral route) at the time of test article administration. Vaccine administration can be postponed until the febrile episode is over.
- Recent vaccination (e.g., vaccine administration within 2 weeks or 4 weeks [live attenuated]) or evidence that a vaccine will be required during the study period (e.g., planned travel).
- Pregnant or plan to become pregnant during the study period.
- Breastfeeding.
- Women highly exposed to children less than 5 years of age will be excluded to reduce risk of RSV infection, including mothers of young children, paediatric nurses, personnel of day nursery.
- Previous participation in a RSV vaccine study.
- Any other significant finding that would increase, according to the Investigator, the risk of having an adverse outcome from participating in the study.
- History of (suspected) hypersensitivity reaction that could be triggered by any component of the vaccine.
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): NCT04519073
Belgium | |
Centre for Vaccinology (CEVAC) | |
Ghent, Belgium, 9000 |
Study Director: | Anna Sumeray, MD | Virometix |
Responsible Party: | Virometix |
ClinicalTrials.gov Identifier: | NCT04519073 |
Other Study ID Numbers: |
VMXRSV306-001 |
First Posted: | August 19, 2020 Key Record Dates |
Last Update Posted: | March 7, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bronchiolitis Infections Bronchitis Respiratory Tract Infections |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |