New influenza vaccine based on MVA.

Phase I clinical trial to assess safety and immunogenicity of an MVA-based influenza vaccine in healthy adults.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28138

Enrollment

Registered

2012-04-18

Start date

2012-10-15

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

influenza A/H5N1 virus smallpox (pokken)

Interventions

1 or 2 intramuscular immunizations with an MVA-based influenza vaccine. Two dosages are tested: 1. 10e7 pfu in 0.5ml

2. 10e8 pfu in 0.5ml.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18-35 years of age; 2. Female volunteers must acquire an acceptable form of contraception during the study period and to have a negative pregnancy test on the days of immunization; 3. Refrain from blood donation during the study period; 4. Written informed consent; 5. Available for the complete study period; 6. Able and willing to comply with all study requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation; 2. Acute or chronic illness; 3. Known allergy to eggs, egg products or chicken protein; 4. Previous immunization with a recombinant MVA; 5. Previous immunization with an influenza A/H5N1 vaccine; 6. Pre-existing immunity to influenza A/H5N1 virus; 7. Pre-existing immunity to vaccinia virus.

Design outcomes

Primary

Measure	Time frame
Safety assessment of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. Study subjects will undergo physical examinations will be performed before and on fixed time points during the study phase. Clinical chemistry is performed on the blood samples that are drawn throughout the study and local and systemic reactions are tracked with a daily dairy card during the first week after immunization.	—

Measure

Time frame

Safety assessment of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. Study subjects will undergo physical examinations will be performed before and on fixed time points during the study phase. Clinical chemistry is performed on the blood samples that are drawn throughout the study and local and systemic reactions are tracked with a daily dairy card during the first week after immunization.

—

Secondary

Measure	Time frame
Assessment of the immunogenicity of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. The immunogenicity will be determined by measuring influenza-specific antibody titers in the hemagglutination inhibition assay and virus neutralization assay. Furthermore HA-specificity of cytotoxic T cells isolated from the vaccinees will be determined. Besides these responses the immunity against the vector will also be characterized and quantified.	—

Measure

Time frame

Assessment of the immunogenicity of the MVA-H5-sfMR vaccine in humans in a dose escalation setup and with one or two immunizations. The immunogenicity will be determined by measuring influenza-specific antibody titers in the hemagglutination inhibition assay and virus neutralization assay. Furthermore HA-specificity of cytotoxic T cells isolated from the vaccinees will be determined. Besides these responses the immunity against the vector will also be characterized and quantified.

—

Contacts

Public ContactJ. Kreijtz

Erasmus MC Department of Virology Dr Molewaterplein 50

fluvec@erasmusmc.nl+31 (0)10 7044066

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)