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About
"Multimeric-001" (M-001) contains conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to pandemic influenza vaccine in the adult population. The current clinical study was designed to assess M-001's standalone and priming action in subjects aged 18-60 years old.
This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.
Full description
This is a multi-center, randomized, double blind active-controlled Phase 2b study. 222 subjects will be randomized 1:1:1 into three groups to receive two sequential non-adjuvanted 0.5 mg or 1.0mg intramuscular injection of M-001 (treatment), or two placebo (saline) injection, before receiving the Alum adjuvanted H5N1 vaccine at a sub optimal dose of 3mcg. Hemagglutinin inhibition (HAI) will be evaluated at baseline and 3 weeks after H5N1 whole virion inactivated pandemic influenza vaccination as a measure of M-001's ability to enhance the humoral response. Cell mediated immune (CMI) responses will also be evaluated at baseline and after immunization with M-001 as a measure of M-001's standalone immunogenicity. The subjects will monitored for safety throughout the study until day 180.
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Inclusion and exclusion criteria
Inclusion Criteria:
Exclusion Criteria
A potential subject who meets any if the following criteria will be excluded from participation in this study:
Has a known allergy to components of the vaccine (e.g. egg products).
Has a history of severe reactions following immunization.
Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
Has a positive urine pregnancy test prior to vaccination or women who are breastfeeding.
Has a history of any of the following (reported by subjects):
Receipt of medicines/treatments that may affect evaluation of immunogenicity such as:
Has received any influenza vaccine within 6 months prior to vaccination in this study.
Has influenza-like illness within 6 months prior to vaccination in this study.
Has an acute illness, including an armpit temperature greater than 38 degrees Celsius (oC), within 1 week of vaccination.
Has a history of alcohol or drug abuse.
Any abnormal haematology values and/or serum chemistries judged by the Investigator as clinically significant.
Ineligible subject based on the judgement of the investigator.
In case there is uncertainty about the participant's medical status regarding any of the exclusion criteria mentioned, the participant's primary care physician will be consulted. Consultation of the primary care physician will only take place after having received written approval from the participant, and will concern medical information about exclusion criteria only.
Primary purpose
Allocation
Interventional model
Masking
224 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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