Respiratory Syncytial Virus (RSV)
Conditions
Interventions
RSV*G or placebo
Sponsors
Intravacc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female, 18-50 years of age, inclusive at screening; 2. Body mass index (BMI) * 18.0 and
Exclusion criteria
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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints (Serious) adverse events will be collected throughout the study at every study visit, solicited (via a questionnaire in a e-diary app) as well as non-solicited. Laboratory safety and vital signs will be obtained multiple times during the course of the study. Tolerability will be assessed via a visual analogue scale (naso-oropharyngeal pain). Assessments will be performed according to the Visit and Assessment Schedule. Immunogenicity endpoints The capacity of the RSV*G vaccine to induce a humoral immune response both systemically and mucosally will be evaluated. Therefore, RSV neutralizing antibodies and RSV-specific immunoglobulin (Ig) A will be measured in nasal washes. In addition, blood samples will be taken to also determine neutralizing antibodies, Palivizumab competing antibodies, F-specific antibodies and (if relevant) specificity for different F protein epitopes. Viral load / shedding endpoints The viral load in nasal washes will be performed in order to evaluate the ability of RSV*G to replicate and to evaluate the shedding. | — |
Countries
The Netherlands
Outcome results
None listed