#1 Clinical Trials Search in Europe

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

Clinical trials are studying INFLUENZA A (H1N1/WSN/1933) NUCLEOPROTEIN FUSED TO C-TERMINAL FRAGMENTS OF TWO AVIAN C4BP ALFA CHAIN SEQUENCES in healthy adults. These studies aim to evaluate safety, immune response, and how well the vaccine may prevent influenza illness. The trials include adults aged 18-59 years and look at both primary vaccination and booster use.

Table of Contents

Clinical trial overview

These studies are testing INFLUENZA A (H1N1/WSN/1933) NUCLEOPROTEIN FUSED TO C-TERMINAL FRAGMENTS OF TWO AVIAN C4BP ALFA CHAIN SEQUENCES in healthy adults to see whether it can help prevent influenza and whether it is safe to use in study settings.[1][2]

Both trials are interventional, which means the researchers give a study treatment and then watch what happens.[1][2]

The available trial data show two Phase 2 studies: one larger prevention study and one smaller study focused on booster and primary vaccination use.[1][2]

Phase 2b prevention study in healthy adults

NCT05569239 is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study in healthy people aged 18 to 59 years.[1]

Multicenter means the study takes place at more than one site.[1] Randomized means people are assigned by chance to study groups.[1] Double-blind means the participants and the study team do not know who receives the vaccine or the placebo.[1]

This study compares one dose of the vaccine with placebo, which is a look-alike treatment used for comparison.[1]

The main goal is to evaluate efficacy, immunogenicity, and safety.[1] Efficacy means how well the vaccine works, and immunogenicity means how strongly it triggers an immune response.[1]

The study is designed to see whether vaccination prevents RT-PCR-confirmed influenza Type A illness starting 14 days after vaccination.[1] RT-PCR is a laboratory test used to confirm infection.[1]

Phase 2a booster and primary vaccination study

NCT06582277 is a Phase 2a, single-center, randomized, double-blind study in healthy adults who had previously received OVX836, Influvac Tetra®, or placebo in earlier studies.[2]

Single-center means the study is done at one site.[2] The study looks at one single administration of INFLUENZA A (H1N1/WSN/1933) NUCLEOPROTEIN FUSED TO C-TERMINAL FRAGMENTS OF TWO AVIAN C4BP ALFA CHAIN SEQUENCES at two dose levels, 180 µg or 480 µg, given by intramuscular injection.[2]

The study compares use as a booster dose, which means an extra dose after earlier vaccination, and as a primary vaccination, which means the first dose in a vaccination series.[2]

The main goal is to evaluate reactogenicity and safety.[2] Reactogenicity means short-term reactions after vaccination, such as local or general symptoms.[2]

What the trials measure

The Phase 2b study measures the first occurrence of RT-PCR-confirmed influenza Type A illness from 14 days after vaccination, with specific respiratory and systemic symptoms lasting at least 24 hours.[1]

The symptoms listed in the trial include sore throat, cough, sputum production, wheezing, difficulty breathing, fever, chills, tiredness, headache, and muscle pain.[1]

The Phase 2a study measures the number and percentage of subjects with solicited local and systemic symptoms within 7 days after vaccination, unsolicited adverse events within 29 days, serious adverse events during the whole study, and cases of influenza or other respiratory infections.[2]

Solicited symptoms are side effects that the study specifically asks people to report.[2] Unsolicited adverse events are any other unwanted medical problems reported during the study.[2]

The Phase 2a study also tracks influenza-like illness and RT-PCR-confirmed influenza A or B, RSV, SARS-CoV-2, and other respiratory infectious agents.[2]

Who the studies include

The Phase 2b trial includes healthy adults aged 18 to 59 years.[1]

The Phase 2a trial includes healthy adults who had already taken part in earlier OVX836, Influvac Tetra®, or placebo studies.[2]

These studies are not described as treatment trials for people who already have flu symptoms at the time of enrollment. Instead, they focus on prevention and immune response in healthy volunteers.[1][2]

How to read the trial results

When reading these studies, the most important points are the trial phase, the study design, the group of people included, and the main outcomes being measured.[1][2]

The larger Phase 2b study is focused on whether the vaccine can prevent confirmed influenza illness in healthy adults.[1]

The Phase 2a study is focused more on safety and immune response after a booster or primary dose in adults with earlier study exposure.[2]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05569239Phase 2Influenza diseaseAuthorised2850
NCT06582277Phase 2InfluenzaCompleted117

FAQ

  • What are the trials studying? The trials are studying whether INFLUENZA A (H1N1/WSN/1933) NUCLEOPROTEIN FUSED TO C-TERMINAL FRAGMENTS OF TWO AVIAN C4BP ALFA CHAIN SEQUENCES can help prevent influenza illness and how safe it is. They also measure the body's immune response after vaccination.
  • Who can take part in these studies? The main study includes healthy adults aged 18 to 59 years. One study also includes healthy adults who previously received OVX836, Influvac Tetra®, or placebo in earlier studies.
  • What phases are these trials in? The trials are in Phase 2. One is a Phase 2b study and the other is a Phase 2a study. Phase 2 studies usually look more closely at safety and early signs of benefit.
  • What conditions are being studied? The studies focus on influenza disease and influenza infection. One trial looks at RT-PCR-confirmed influenza Type A illness, which means flu confirmed by a lab test.
  • What outcomes are the trials measuring? One trial measures the first case of RT-PCR-confirmed influenza Type A illness after vaccination. The other trial measures local and whole-body side effects, serious side effects, and cases of influenza and other respiratory infections.

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

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effectiveness and Safety of OVX836 Vaccine for Preventing Influenza in Healthy Adults Aged 18-59

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland France Germany

Glossary

  • Phase 2: A trial stage that looks more closely at safety, immune response, and early signs that a treatment may work.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team know who gets the vaccine or placebo during the trial.
  • Placebo: A look-alike treatment that does not contain the active study vaccine. It is used for comparison.
  • Immunogenicity: How well a vaccine triggers the immune system to make a response.
  • Safety: Information about side effects and whether the study treatment causes harm.
  • Reactogenicity: Short-term reactions after vaccination, such as local pain or general symptoms.
  • RT-PCR: A laboratory test used to detect the flu virus and confirm infection.
  • Influenza-like illness: A set of flu symptoms such as cough, sore throat, fever, tiredness, or muscle pain.
  • Serious adverse events: Important medical problems that happen during a study and may need urgent care.

References