RSV vaccine study - GSK ADJ001

The Clinical Trial Site at the Institute of Tropical Medicine (ITM) is seeking volunteers for a new clinical trial entitled ADJ 001. In this study, we will evaluate the effectiveness of a novel combination vaccine created by the company GlaxoSmithKline (GSK) against respiratory syncytial virus (RSV) and the Human metapneumovirus (hMPV).

• For whom: Volunteers aged 60 years or older

• Start: December 2026

• Duration: 2 years

• Study visits: 6 visits to the study centre and 1 follow-up phone call

• Compensation: Fixed compensation per study visit

Purpose of the study

RSV is a major cause of serious respiratory illness in older adults worldwide. It is a common virus that most people first encounter in early childhood. While repeated exposure usually causes mild symptoms, the risk of severe disease increases with age. This virus can affect both the upper and lower respiratory tracts, including the lungs. In severe cases, infection can lead to hospitalisation or even death.

Human metapneumovirus (hMPV) is another virus that causes similar respiratory illnesses in older adults. Studies show that hospitalisation rates due to hMPV infections are similar to those associated with RSV infections.

Both viruses are underdiagnosed because testing is not routinely performed in patients with flu-like symptoms. Currently, effective antiviral treatments for RSV and hMPV are limited, and there is no approved combination vaccine that protects against both viruses. Therefore, this study aims to investigate the effectiveness of a combination vaccine in an older population.

How is the study conducted?

When you are invited to participate, you will be screened during the first visit. Several factors are taken into account when determining eligibility, and the study doctor will review these with you. Once you agree to participate and the doctor has reviewed the eligibility criteria, you may start the study. The vaccine will be administered on Day 1, and blood samples will be collected at each on-site visit.

The visits will be scheduled as follows:

• 6 visits to the study centre on:

  • Day 1, Day 8 and Day 31

  • Month 6, Month 12 and Month 24

• 1 follow-up phone call in:

  • Month 4

To evaluate how well the new combination vaccine works in preventing RSV and hMPV infections, a small number of participants (less than 6%) will receive a placebo vaccine. This will be determined randomly by a computerised system. Neither you nor the study centre staff will know which vaccine you have received until the end of the study.

Throughout the study, you will be asked to record any respiratory symptoms in an electronic diary.

Who can participate?

We are looking for volunteers aged 60 years or older who have never received an RSV and/or hMPV vaccine.

There are additional criteria that the study doctor will check to determine whether you are eligible to participate in the study. These will be reviewed with you during the first study visit. The main criteria are listed on the registration page (see below).

Potential risks and inconveniences

Participation in this study involves having a small amount of blood drawn at specific time points. The total amount of blood collected is not expected to pose a risk to your health. The blood draw itself may cause some discomfort and possibly a bruise.

Compensation

To compensate you for your participation, you will receive a fixed fee for each study centre visit.

If you agree to participate in the study, we strongly encourage you to complete the entire study. However, you can withdraw from the study at any time.

Questions?

Contact us at studies@itg.be.