• To investigate the safety and tolerability of two ascending dose levels and two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.• To investigate safety and tolerability of three intramuscular dose…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
• Humoral immunity: Magnitude of MERS-S-specific antibody responses (ELISA and
neutralization assays) monitored in approved laboratories
Background summary
MERS is a potentially fatal disease under tight epidemiologic control by the
WHO and currently with-out registered prevention or treatment options. The
first case of MERS-CoV infection was identified in a patient with acute
pneumonia and renal failure in the Kingdom of Saudi Arabia (KSA) in June 2012 [
]. As of Augustus 2021, 2578 laboratory-confirmed cases of MERS-CoV and 888
deaths have been reported, resulting in a case-fatality rate of 34.4% (WHO
Situation Re-port). MERS-CoV shows an expanding geographical distribution.
While infections have been mainly observed in the Middle East, 27 countries
have reported MERS cases [ ]. To date three cases have been imported to
Germany, all with fatal outcome.
Study objective
• To investigate the safety and tolerability of two ascending dose levels and
two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in
healthy study subjects.
• To investigate safety and tolerability of three intramuscular dose
administrations of the candidate MVA-MERS-S_DF-1 vaccine in healthy study
subjects using the immunization schedule D0/D28/D224 or D0/D56/D224
Study design
Two-center, randomized, double-blind, placebo-controlled, dose-finding phase Ib
study with an open-label run-in phase
Intervention
Vaccination with MVA-MERS-S_DF1
Study burden and risks
Participation in a Phase Ib study may not have a therapeutic benefit for
healthy subjects. To the best of our knowledge, the study drug appears to be
safe and no serious side effects are expected in this study. The MVA vaccine
vector used has been widely used (more than 6,500 individuals, including
children, cancer patients, and immune-compromised patients) in clinical trials
for other infectious diseases. No unexpected side effects were found. Side
effects are also not expected from the antigen introduced into the vector. No
SAEs were found during the first small phase Ia study testing MVA-MERS-S
The results of the preclinical studies show a favorable safety and tolerability
profile. The chosen study design for the sequential dosing of Part A and Part B
is considered sufficient to ensure the safety of the subjects.
Vaccine recipients may benefit from protection against future MERS outbreaks.
However, at this stage of vaccine development, participants are strongly
advised not to consider themselves protected against MERS after vaccination.
In summary, preclinical and clinical results indicate a favorable safety and
tolerability profile. Taking into account the safety measures to minimize the
risks to study participants, exposure of healthy subjects to the MVA-MERS-S
vaccine is justified, as the potential risks and harms to study participants do
not outweigh the potential benefits for medical research, medical practice and
ultimately for individuals at risk of MERS infection.
Martinistraße 52
Hamburg 20246
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Martinistraße 52
Hamburg 20246
DE
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000715-83-NL |
| ClinicalTrials.gov | NCT04119440 |
| CCMO | NL75312.000.20 |