Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/11/2016 |
| Start Date: | August 2015 |
| End Date: | May 2016 |
A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects
A total of 63 subjects will be recruited into three groups (18 subjects per group will
receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen
suspension of MVA BN RSV.
Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per
0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen
suspension of MVA BN RSV.
Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per
0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
Inclusion Criteria:
- signed and dated an informed consent form
- Body mass index ≥ 18.5 and < 35.
- Women of childbearing potential (WOCBP) must have used an acceptable method of
contraception
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
- History of any serious medical condition.
- History of or active autoimmune disease.
- Known or suspected impairment of immunologic functions.
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