Challenge Trials

A clinical trial is an investigation where medications, vaccines and other therapies are tested on people who volunteer to participate.

Doherty Clinical Trials specialises in what is known as early phase trials. Participants in early phase trials are usually healthy volunteers and the investigation is designed to see if the potential treatment or vaccine is safe.

Doherty Clinical Trials also has the capacity to conduct later phase trials, which investigate whether a treatment works or is better than any treatment already available.

A human challenge trial is a type of early phase clinical trial that allows researchers to better understand the immune system and infectious diseases, and to also rapidly test the effectiveness of vaccines and treatments.

Human infection challenge trials involve exposing healthy volunteer participants to a well-characterised infectious agent (such as a bacteria or virus) in a controlled environment. A well-characterised infectious agent means that “the bug” has been tested for safety in humans and this has been approved by our Ethics Committee. When testing a new vaccine or treatment, “the bug” is applied either after the volunteer has been vaccinated, or before they have received treatment.

Participants are monitored closely by a medical team, with observations and tests helping researchers better understand the effectiveness of new vaccines and treatments. These trials are carefully designed to ensure that the trial can run safely and that researchers learn how well these vaccines or treatments will impact infectious diseases globally.

The COVID-19 pandemic has taught us the importance of being able to rapidly understand infectious pathogens and test vaccines and treatments to decrease global disease and deaths. Human challenge trials give critical real-time information which allows for rapid development of vaccines and treatment.

Human challenge trials have been used to develop new medicines and vaccines globally for decades and have contributed to the research and development of vaccines and/or treatments for:

• Cholera
• The common cold virus
• Malaria
• Influenza
• Dengue
• Typhoid fever
• Gastrointestinal infections (e.g. those cause by Norovirus, Salmonella and E.coli)
• COVID-19

As a participant, you will be reimbursed for your time and contribution, which can include travel expenses and parking. Each study has different reimbursement amounts.

For human challenge trials, you may need to stay on site for several days. So depending on the length of the trial, the reimbursement amounts can add up.

Reimbursements are not assessable income for tax purposes and don’t impact social welfare payments.

If you can’t complete the trial, you’ll get a partial payment to cover your time. You might not be paid for screening appointments unless this is specified in advance.

Like any medication, vaccine or treatment (and even some over-the-counter products), human challenge trials carry some risk and potential for side effects. To minimise any risk, all the infectious pathogens used are very well understood and all treatments or vaccines have already been tested for safety over many years before they are used in human challenge trials.

Human challenge trials must adhere to both global and national regulations. Australia has strict requirements for clinical trials and we follow all guidelines and regulatory requirements including those set out by the principles of Good Clinical Practice, the Therapeutic Goods Administration and Medicines Australia. In Australia, all trials are approved by an experienced, independent Human Research Ethics Committee registered with Australia’s National Health and Medical Research Council.

We believe it is important that researchers involved in human challenge trials continually assess the risks and benefits of these types of trials to uphold the safety and rights of participants. We also ensure that all participants are fully informed of any risks and benefits, have ample opportunity to ask questions and feel comfortable before they consent to enrolling and participating in our studies.

The types of people who can participate in each trial depends on the purpose of the trial and the information the researchers would like to collect. The type of participant required for each study is dependent on the specific trial and will be described in the recruitment materials. This will give you an early idea about what the researchers are looking for. The early screening process will give you more information about your eligibility.

During the screening process, our team will advise you if you are suitable for the trial in progress. If you are not, there may be other trials for which you fill the selection criteria.

If you are interested in taking part in a human challenge trial, please register your interest here.

All clinical trials have criteria for participants. These are designed to decrease risk for participants and help researchers select the people who help them answer the research questions the trial is investigating.

All volunteers will need to provide consent to participate and will be asked to answer medical questions specific to the trial. You will be assessed by a doctor and have medical examinations to make sure it is safe for you to be involved in the trial. To understand what you can expect during the screening process, visit our patient screening process page.

Human challenge trials often require a short stay in a clinical unit. In some cases, participants may be quarantined and isolated from other participants until the end of the challenge period, when they can resume normal activities. After a short stay in the unit, participants may have follow-up appointments in the future, either in person or over the phone.

At Doherty Clinical Trials, participants in our trials stay in Australia’s only unit specifically devoted to human challenge studies. In addition to the highest quality facilities for our researchers, as a participant our team will make sure you are well looked after and that you are comfortable, healthy and safe at all times.

All meals are provided and we can accommodate any dietary requirements. The space includes areas for relaxation and work, where participants will have access to complimentary entertainment in both common and private areas, such as TVs, gaming consoles and WiFi. All our individual rooms are equipped with a bed, private en-suite bathroom and desk, where participants can set up their own laptops for study, work or for a chat with friends and family.