Active not recruitingPHASE1INTERVENTIONAL

A Study to Evaluate Safety and Immunogenicity of Haemophilus Influenzae Serotype A Vaccine

This study is looking at a new vaccine designed to protect against Haemophilus influenzae serotype a (Hia), a type of bacteria that can cause serious illnesses like meningitis. Hia has become a particular concern for Indigenous children in Canada and Alaska, similar to how another type, Hib, previously caused problems before a vaccine was developed. This early-stage study, called Phase 1, involves healthy adults aged 18 to 40. The main goal is to see if the new Hia vaccine is safe and if it helps the body create protective antibodies. The findings from this study will be crucial for deciding whether to continue developing this promising vaccine to help prevent this infection.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

InventVacc Biologicals Inc.

Enrolment target

Start

29 May 2024

Estimated completion

15 Sep 2025

Haemophilus Influenzae Meningitis Invasive Haemophilus Influenzae Disease

What is this study about?

This research is focused on a new vaccine to protect against a serious bacterial infection called Haemophilus influenzae serotype a, or Hia. Hia can lead to very severe health problems, including sepsis (a life-threatening reaction to infection) and meningitis (an infection around the brain and spinal cord). For many years, another type, Haemophilus influenzae serotype b (Hib), caused similar serious illnesses, but a successful vaccine dramatically reduced these cases. Unfortunately, Hia has now become a leading cause of these invasive infections, particularly affecting Indigenous children in Canada and Alaska. Because Hia causes similar problems to Hib, scientists believe a vaccine is the best way to protect these vulnerable communities.

This study is the very first time this Hia vaccine has been given to people. It's called a 'Phase 1' study, which means the main aim is to carefully check its safety. Researchers also want to see if the vaccine helps the body's immune system to produce special protective substances called antibodies. These antibodies are what would fight off the Hia bacteria if someone were exposed to it after vaccination. This information is a vital first step in developing the vaccine further.

Various Canadian health groups and researchers are working together on this project. They hope that if this study shows good results for safety and immune response, it will pave the way for more studies and eventually make the vaccine available to those who need it most.

Key takeaways

This is the first study of a new Hia vaccine in humans.
The main goals are to check if the vaccine is safe and if it helps the body create protective antibodies.
The study includes healthy adults aged 18-40.
It aims to prevent serious infections, especially in vulnerable communities.
Your participation could help develop an important new vaccine.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 40 years old. You must be willing to follow all the study instructions and attend appointments, which will be checked through your medical history and a basic health check-up. Your doctor leading the study will decide if you are a good fit.

If you have a long-term health condition, you might still be able to take part if it's well-controlled and your study doctor thinks it won't affect the study results or put you at extra risk. Generally, this means your condition hasn't gotten worse or changed significantly in the last three months.

Women who could become pregnant must have negative pregnancy tests before vaccination and use effective contraception during the study. If you are pregnant or breastfeeding, you cannot participate. Also, your body mass index (BMI) needs to be 32 or less.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 40 years old?
Are you generally healthy, or is any long-term condition you have well-controlled?
Is your BMI 32 or lower?
If you are a woman, are you not pregnant or breastfeeding, and willing to use contraception?
Are you able to attend all study visits and provide blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive doses of the new Hia vaccine. After each vaccination, you will need to keep a record of any side effects you notice for 7 days. You'll also be monitored for any unexpected health changes for 28 days after each dose. To check if the vaccine is helping your body build protection, blood samples will be taken 28 days after each vaccine dose, and again 208 days (about 7 months) after the first dose. The study will take place over several months, with different check-up points.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping scientists understand if this new vaccine is safe and if it can protect against Hia infection. While you might not directly benefit from the vaccine depending on future risks, your participation is very important for potentially protecting others in the future. As with any vaccine, there might be temporary side effects like soreness at the injection site or feeling unwell. All potential risks will be thoroughly explained to you, and your safety will be carefully monitored throughout the study. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Canadian Center for Vaccinology (CCfV)
Verified postcode
Halifax, Canada
McGill University Health Centre (MUHC) Vaccine Study Centre
Verified postcode
Montreal, Canada

Common questions

What is Haemophilus influenzae serotype a (Hia)?

Hia is a type of bacteria that can cause serious infections, such as meningitis (infection of the brain and spinal cord lining) and sepsis (blood poisoning).

Why is this vaccine being developed?

Hia has become a major cause of serious illness, especially among Indigenous children in certain parts of Canada and Alaska. This vaccine aims to prevent these dangerous infections.

What does 'Phase 1 study' mean?

A Phase 1 study is the first time a new treatment or vaccine is tested in people. Its main goals are to check for safety and to see what dose is best, and if it triggers a protective response from the body.

Will I get sick from the vaccine?

The vaccine does not contain live Hia bacteria, so it cannot give you the infection. You might experience common vaccine side effects like a sore arm or feeling a bit under the weather, which are usually mild and temporary.

Who is funding this research?

This research is a collaborative effort involving several Canadian public health organisations, research networks, and other partners, including the Public Health Agency of Canada and the National Research Council.