A Study of OVX836 Influenza Vaccine Given as Booster or Primary Vaccination in Healthy Adults Who Previously Received OVX836, Influenza Vaccine, or Placebo

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What is this study about?

This clinical trial focuses on testing a new influenza vaccine called OVX836. The vaccine is given as a single intramuscular injection and is being studied at two different dose levels. The purpose is to evaluate how well the vaccine works and how safe it is when given to healthy adults who have previously received either OVX836, Influvac Tetra, or placebo in earlier studies.

The study involves comparing the effects of the vaccine when used as either a booster shot in people who have already received OVX836 before, or as a first-time vaccination in those who haven’t. Participants will receive a single injection of either 180 or 480 micrograms of the vaccine solution. The study is designed as a double-blind trial, which means neither the participants nor the researchers directly involved in giving the vaccine know who receives which dose.

During the study, researchers will monitor participants’ immune system responses to the vaccine and track any side effects that may occur. This includes checking for both expected reactions at the injection site and throughout the body, as well as any unexpected health issues. The study will also track whether participants develop any respiratory infections, including influenza, during the study period.

1 Initial vaccination

You will receive a single intramuscular injection of the study vaccine. The dose will be either 180µg or 480µg of OVX836 influenza vaccine.

The specific dose will be assigned randomly, and neither you nor the medical staff will know which dose you receive (this is called double-blind).

2 First week monitoring

For 7 days after vaccination, you will need to record any reactions at the injection site (such as pain or redness) and any general symptoms in an electronic diary.

The medical team will monitor your health status during this period.

3 Day 8 assessment

You will need to visit the study center for a blood sample collection.

The blood sample will be used to measure your body’s immune response to the vaccine.

4 29-day follow-up period

You will need to report any unexpected health issues for 29 days after vaccination.

On day 29, you will visit the study center for another blood sample collection to measure your immune response.

5 Extended monitoring

The study will continue to monitor your health status until the study ends (estimated June 2025).

You will need to report any flu-like symptoms or respiratory infections that occur during this period.

Who Can Join the Study?

You must voluntarily agree and sign an informed consent form to participate in the study
You must be considered healthy based on your medical history and examination
You must meet specific reproductive requirements for both male and female participants
You must have previously participated in either:
- The OVX836-002 study and received either OVX836 180µg or Influvac Tetra®, or
- The OVX836-003 study
Your age must be between 20 and 64 years old
You must be willing and able to:
- Commit to participating for the entire study duration
- Follow all study procedures carefully
You must be able to use and complete an electronic diary (eDiary)

Who Cannot Join the Study?

History of severe allergic reactions or anaphylaxis to any vaccine components
Pregnancy or breastfeeding women
Participation in another clinical trial within the past 3 months
Current acute illness (temporary illness like cold or fever) or infection
History of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
Immunodeficiency (weakened immune system) or use of medications that suppress the immune system
Receipt of any influenza vaccine within the past 6 months
History of Guillain-Barré syndrome (a rare disorder where the immune system attacks the nerves)
Any chronic medical condition that is not well controlled
Current use of blood thinners or medications that affect blood clotting
Bleeding disorders or conditions that make it difficult for blood to clot
History of serious adverse reactions to previous vaccines

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2024

Trial locations

Investigated drugs:

INFLUENZA A (H1N1/WSN/1933) NUCLEOPROTEIN FUSED TO C-TERMINAL FRAGMENTS OF TWO AVIAN C4BP ALFA CHAIN SEQUENCES

OVX836 is an investigational influenza vaccine being tested to protect against flu. It’s a new type of flu vaccine that is given as an injection into the muscle. The vaccine aims to provide protection against influenza viruses.

Influvac Tetra is an established seasonal flu vaccine that helps protect against four different strains of influenza virus. It is given as an injection into the muscle and is commonly used to prevent flu infections.

Note: The trial includes different doses of OVX836, but these are variations of the same vaccine rather than different medications.

Investigated diseases:

Influenza

Influenza – A highly contagious viral respiratory infection that affects the nose, throat, and sometimes the lungs. The virus spreads through tiny droplets when infected people cough, sneeze, or talk. Symptoms typically appear suddenly and include fever, chills, muscle aches, fatigue, headache, dry cough, and runny or stuffy nose. The illness usually develops within 1-4 days after exposure to the virus. The infection causes inflammation of the respiratory tract and can vary in severity from mild to severe.

Trial ID:

2024-516267-83-00

Protocol code:

OVX836-007

NCT ID:

NCT06582277

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of OVX836 Influenza Vaccine Given as Booster or Primary Vaccination in Healthy Adults Who Previously Received OVX836, Influenza Vaccine, or Placebo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?