RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.

A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02864628

Enrollment

Registered

2016-08-12

Start date

2016-09-30

Completion date

2017-10-27

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV Vaccines, Respiratory Syncytial Virus Vaccines

Brief summary

A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.

Interventions

BIOLOGICALMVA-BN-RSV

MVA-mBN294B

OTHERPlacebo

Tris Buffered Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* signed and dated an informed consent form and HIPAA. * Subjects without symptomatic cardiopulmonary and/or metabolic disease. * Body mass index (BMI) ≥ 18.5 and ≤ 34.9. * Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus. * Electrocardiogram (ECG) without clinically significant acute findings. * WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.

Exclusion criteria

* History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial * Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum * pregnant or breast-feeding women. * History or current clinical manifestation of any serious medical condition. * History of or active autoimmune disease. * Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I. * Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * History of anaphylaxis or severe allergic reaction to any vaccine. * Chronic systemic administration defined as more than 14 days of \> 5 mg prednisone per day

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of serious adverse events	Screening up to week 34 after first vaccination	Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

Secondary

Measure	Time frame	Description
RSV-specific humoral immune response	humoral immune response is measured up to week 34	To assess the RSV-specific serum antibody responses

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026