COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nordsjaellands Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-12-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic

This study aims to evaluate the specific and non-specific effects of innate immune activation induced by the AS01-adjuvanted RSV vaccine in individuals at high risk for severe respiratory disease and insufficient vaccine response.
Our specific objectives are:
1. To investigate whether the AS01-adjuvanted RSV vaccine induces potent mucosal and systemic innate responses in COPD patients aged ≥ 60 years.
2. To evaluate whether ipsi- and/or contralateral co-administration with PCV20 enhances the vaccine-specific adaptive immune response to pneumococcal antigens.
3. To assess non-specific effects of the AS01-adjuvanted RSV vaccine regarding a) the duration of innate enhancement that affects adaptive responses using a controlled delayed vaccine-coadministration model, b) mucosal protection against viral and bacterial respiratory pathogens, and c) sustained systemic control of viral replication in chronic or latent infections.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. A confirmed COPD diagnosis by a respiratory medicine specialist requiring attention at the hospital's outpatient clinic
2. Age≥60 years
3. Previous PPV23 vaccination more than one year before inclusion
4. Volunteer agrees to participate in all aspects of the trial and has signed the informed consent.

Exclusion criteria 6

1. Immunocompromised status (primary, or secondary immunodeficiencies e.g., HIV, cancer therapy chemo, any medications that would suppress the immune system)
2. Receipt of any PCV or RSV vaccine at any time
3. Acute illness within the previous 14 days (including COPD exacerbations and fever)
4. Receipt of any other vaccine within the last four weeks
5. Allergens towards one of the ingredients in the trial medication.
6. Previous illness with Gullain-Barré syndrome.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Interferon-gamma (IFN-γ) Response. Measured as the increase in systemic IFN-γ levels at 24 hours post-vaccination compared to baseline.

Secondary endpoints 6

1. NK Cell Activation. Change in Natural Killer (NK) cell activation markers (e.g., CD69 expression) 24 hours post-vaccination compared to baseline.
2. Gene Signature of Innate Activation. The expression levels of a predefined set of genes associated with the interferon response (e.g., IRF7, IFIT1) measured via transcriptomic analysis of peripheral blood mononuclear cells (PBMCs) pre- and post-vaccination.
3. Pneumococcal-Specific IgG Antibody Titers and Functional activity a. Increase in IgG GMCs for 12 pneumococcal serotypes included in PCV20, measured 30 days and 180 days post-vaccination. b. Assessment of functional pneumococcal antibodies through OPA for key serotypes, including serotype 3, at 30- and 180-day post-vaccination. c. Antibody glycosylation analysis (sialylation/desialylation), at 30- and 180-day post-vaccination
4. CD4+ T-cell Responses. Quantification of polyfunctional CD4+ T-cell responses (Th1-biased), as assessed by cytokine production (IFN-γ, TNF-α, IL-2) following ex vivo stimulation with RSV and pneumococcal antigens.
5. RSV antibody titers. RSV pre-F-binding antibody titers will be quantified on samples obtained on days 0, 30, and 180
6. CD4 Responses. Directed against RSV and the conjugate protein of the pneumococcal vaccine.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nordsjaellands Hospital

Sponsor organisation

Nordsjaellands Hospital

Address

Dyrehavevej 29

City

Hilleroed

Postcode

3400

Country

Denmark

Scientific contact point

Organisation

Nordsjaellands Hospital

Contact name

Zitta Barrella Harboe

Public contact point

Organisation

Nordsjaellands Hospital

Contact name

Zitta Barrella Harboe

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications