VOLUNTEERS NEEDED FOR RSV mRNA VACCINE STUDY

Why is this study being conducted?

The purpose of the study is to evaluate the safety and immunogenicity of a respiratory syncytial virus (RSV) mRNA vaccine candidate in adult participants 60 years of age and older. Respiratory syncytial virus is a leading cause of respiratory illness in adults (second to the flu) with no specific approved prevention or treatment options.     

Who is eligible to participate in this study?

Men and women 60 years of age or older who:

  • Are in good general health
  • Have no current immunodeficiency disease/condition
  • Have not had previous allergic reactions to vaccines

Applicants who express interest in participating in this study will be reviewed and contacted as other requirement criteria must also be met.

What happens during the study?

Screening

Participants will have a screening visit (up to 2 weeks before study vaccination) to confirm if they are eligible. If the criteria is met, the participant will be assigned to a treatment group.

Vaccine assignment

Each participant will be assigned by chance (like the flip of a coin) to one of 7 intervention groups. Up to 6 vaccine formulations and one placebo group are planned to be tested and 1 out of 7 participants will receive placebo. Each participant will receive one vaccination and will be in the study for approximately 12 months. However, if participants are selected to be part of an additional booster cohort, they will receive a second vaccination (approximately 12 months after receiving the 1st vaccine) where 1 out of 2 participants will receive placebo, and be in the study for an additional year.

What you will need to do

Participation in this study will involve around 7 onsite clinic visits plus 4 telephone visits over 12 months.

For those involved in the booster cohort, an additional 7 onsite clinic visits plus 4 telephone visits over another 12 months (total duration for participants in booster cohort is 24 months) are required. 

Why should individuals consider participating in this study?

If a person is eligible to participate, his/her data may help the research team learn more to advance the development of a vaccine that may protect against disease caused by the RSV virus. Respiratory syncytial virus is a leading cause of respiratory illness in adults (second to the flu) with no specific prevention or treatment options. While RSV can infect anyone, for some people, especially babies, older adults, and those with heart or lung problems or weakened immune systems, symptoms can be more severe. RSV infection can cause problems like worsening congestive heart failure (when your heart can’t pump enough oxygen to your body) or pneumonia (an infection of the lungs).

Participation in this study is completely voluntary, and participants can decide to withdraw at any time.

Eligible participants will be reimbursed for their time and travel associated with each study visit.

If you would like to register your interest click here.

For further information please contact

Clinical Trial Coordinator, Amy Finlayson

+61 7 567 80112

email: [email protected]