VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
The purpose of this study is to test if an adjuvant (called SPA09) can improve the strength and function of an mRNA vaccine, without giving unwanted effects. This study will use an experimental mRNA vaccine designed to prevent lung disease caused by two viruses, named RSV and hMPV. Healthy adults, 60 to 75 years of age will participate in this Phase 1, randomized, modified double-blind, multi-center, parallel group, multi-arm study. Each participant will remain in the study for approximately 6 months.
We are currently recruiting participants for a medical research study that is testing a new investigational vaccine to protect against disease caused by the respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
- Category
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Trial status
Recruiting
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Trial phase
Phase 1 Drug TrialEarly stage studies seeking initial evidence of safety, dosage and efficacy in small numbers of patients or healthy volunteers.
- Registry listing
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ERM Project ID
110435
Trial contact details
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Contact person
RIO Clinical Trials Unit
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Phone
07 3163 1369
What you need to know
Who can take part?
- Aged 60 to 75 years on the day of inclusion
- You are considered medically stable based on history and physical examination by a qualified medical doctor at this site.
What is involved for me?
- Informed Consent
- Collection of medical history, medication and previous vaccinations
- Physical examination, Vitals signs, ECG
- Blood tests and mucosal sample collection
- Vaccination with investigational product
- Diary entry for 28 days to record any vaccine reactions.