Status:
COMPLETED
Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus
Lead Sponsor:
Virometix
Collaborating Sponsors:
Center of Vaccinology, Ghent, Belgium (CEVAC)
Expert Clinical Services Organization, Brussels, Belgium (ECSOR)
Conditions:
Acute Bronchiolitis Due to Respiratory Syncytial Virus
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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. T...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04519073
Start Date
September 7 2020
End Date
March 2 2022
Last Update
March 7 2022
Active Locations (1)
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1
Centre for Vaccinology (CEVAC)
Ghent, Belgium, 9000