A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects

A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects - Study to test safety and immune response to a vaccine for MERS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50932

Enrollment

Registered

2020-10-28

Start date

2021-10-07

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Middle Eastern Respiratory Syndrome (MERS)

Interventions

Vaccination with MVA-MERS-S_DF1

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) Written informed consent form. 2) Healthy male and female subjects aged 18-55 years. 3) No clinically significant acute health problems as determined from medical history and physical examination at screening visit. 4) Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening. 5) Non-pregnant, non-lactating female with negative pregnancy test. 6) Females who agree to comply with the applicable contracep-tive requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1) Receipt of vaccination against MERS in medical history. 2) Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination. 3) Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product. 4) Evidence in the subject*s medical history or in the medical examination that might influence either the safety of the sub-ject or the absorption, distribution, metabolism or excretion of the investigational product. 5) Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes. 6) Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Design outcomes

Primary

Measure	Time frame
• Overall safety and tolerability of two ascending dose levels and two different dosing intervals of MVA MERS S_DF-1 administered at three time points • Frequency and severity of local injection site reactogenicity signs and symptoms • Occurrence and frequency of adverse events • Change from baseline safety laboratory parameters	—

Secondary

Measure	Time frame
• Humoral immunity: Magnitude of MERS-S-specific antibody responses (ELISA and neutralization assays) monitored in approved laboratories	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)