Clinical study to evaluate safety, tolerability and effects on the immune system of a common cold vaccine in healthy adults
Completed
- Conditions
- Prophylaxis against infection with Respiratory Syncytial Virus
- Registration Number
- NL-OMON19920
- Lead Sponsor
- Intravacc, Bilthoven, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1.Healthy male or female, 18-50 years of age, inclusive at screening;
2.Body mass index (BMI) > 18.0 and < 32.0 kg/m2;
Exclusion Criteria
1.Immune-compromised (known or expected immune deficiency, disease, or use of medication that may affect the immune system);
2.Close contact with infants (<2 years of age) and immune-compromised individuals, during 14 days starting from day of vaccine administration;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability: Naso-oropharyngeal pain during and shortly after administration (VAS)<br>Safety: <br /><br>- occurence in treatment-emergent (S)AEs<br /><br>- occurrence and severity of solicited adverse events (local and systemic reactions)<br /><br>- change in laboratory safety data, vital signs, body temperature
- Secondary Outcome Measures
Name Time Method Viral load and shedding in nasal wash by CCID50 and PCR: presence and duration of presence of viral load<br>Immunogenicity<br /><br>- % of subjects with increase in virus neutralizing titers in serum or nasal wash<br /><br>- mean fold-increase in virus neutralizing titers<br /><br>- Increase in RSV-specific IgA in nasal wash and percentage of subjects with increase in IgA titers <br /><br>- Palivizumab-competing antibodies in serum<br />