Prophylaxis against infection with Respiratory Syncytial Virus
Conditions
Interventions
RSVdG Vaccine or placebo
Sponsors
Intravacc, Bilthoven, the Netherlands
Eligibility
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 < 32.0 kg/m2; 3. Good health, based upon the results of medical history, physical examination, vital signs, ECG, and laboratory profiles of both blood and urine; 4. Pre-existing virus neutralization antibody titers (VNT) against RSV below 9.5 log2(titer) at screening; 5. Willing to comply with effective contraception during the study if subject is male or woman of child bearing potential, up to 90 days after the vaccine administration; 6. Signed informed consent prior to any study-mandated procedure; 7. The ability to communicate well with the Investigator in the Dutch language 8. Willing to comply with the study restrictions.
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 (<2 years of age) and immune-compromised individuals, during 14 days starting from day of vaccine administration; 3. Chronic airway diseases; 4. Airway infection in the period of 14 days before first vaccine administration; 5. Active hay fever or other allergies that involve the airways; 6. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies; 7. Any anatomic or neurologic abnormality impairing the gag reflex, or associated with an increased risk of aspiration, or any abnormality significantly altering the anatomy of the nose or nasopharynx; 8. History of frequent epistaxis (nose bleeds); 9. Evidence of any other active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator. 10. Clinically significant abnormalities, as judged by the investigator, in laboratory test results 11. Positive Hepatitis B surface antigen, Hepatitis B antibody, Hepatitis C antibody, or human immunodeficiency virus antibody at screening; 12. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study or 90 days after vaccine administration; 13. Use of any medications (prescription or over-the-counter (OTC)), within 14 days of vaccine administration, or less than 5 half-lives (whichever is longer). Exceptions is are paracetamol (up to 4 g/day).. Other exceptions will only be made if the rationale is clearly documented and accepted by the investigator. 14. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent; 15. Smoking for at leastin the 90 days preceding screening; 16. Positive test for drugs of abuse at screening or pre-dose; 17. Participation in an investigational drug or device study within 3 months prior to first dosing or more than 4 times a year; 18. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening or intention to donate blood or blood products during the study; 19. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: Naso-oropharyngeal pain during and shortly after administration (VAS) Safety: - occurence in treatment-emergent (S)AEs - occurrence and severity of solicited adverse events (local and systemic reactions) - change in laboratory safety data, vital signs, body temperature | — |
Secondary
| Measure | Time frame |
|---|---|
| Viral load and shedding in nasal wash by CCID50 and PCR: presence and duration of presence of viral load Immunogenicity - % of subjects with increase in virus neutralizing titers in serum or nasal wash - mean fold-increase in virus neutralizing titers - Increase in RSV-specific IgA in nasal wash and percentage of subjects with increase in IgA titers - Palivizumab-competing antibodies in serum | — |
Contacts
Public ContactI. Visser, de
Centre for Human Drug Research
Outcome results
None listed