Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

NCT05160766 | Completed Phase 2 Results DMC

• 3 other identifiers: EU-COVAT-1_AGED2021-004526-29uni-koeln-4602
• Study Type: interventional
• Target: 323
• Locations: 4 countries
• Sites: 9

Brief Summary

This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population. Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.

Conditions

Prevention of COVID-19

Keywords

SARS-CoV-2; COVID-19; Vaccination; Immunogenicity; BNT162b2; mRNA-1273; Booster; Elderly; head-to-head comparison

Outcome Measures

Primary Outcomes (1)

• Antibody Titre Increase 14 Days After Study Vaccination Dose.

  Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.

  From Day 0 until Day 14

Secondary Outcomes (5)

• Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose

  From Day 0 until Day 14

• Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose

  From Day 0 until Day 14

• Antibody Titre Level at 12 Months After a Study Vaccination Dose

  From Day 0 until Month 12

• Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose

  From Day 0 until Month 12

• Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose

  From Day 0 until Month 12

Other Outcomes (5)

• Number of Participants With Unsolicited AEs

  From Day 0 until Month 12

• Number of Participants With Solicited AEs

  From Day 0 until Day 7

• Number of Participants With Rate of SAEs Grade ≥3

  From Day 0 until Month 3

Study Arms (4)

BNT162b2 (Part A)

ACTIVE COMPARATOR

vaccination with BNT162b2 as 3rd vaccination

Biological: Comirnaty (BTN162b2)

mRNA-1273 (Part A)

ACTIVE COMPARATOR

vaccination with mRNA-1273 as 3rd vaccination

Biological: Spikevax (mRNA-1273)

BNT162b2 (Part B)

ACTIVE COMPARATOR

vaccination with BNT162b2 as 4th vaccination

Biological: Comirnaty (BTN162b2)

mRNA-1273 (Part B)

ACTIVE COMPARATOR

vaccination with mRNA-1273 as 4th vaccination

Biological: Spikevax (mRNA-1273)

Interventions

Comirnaty (BTN162b2) BIOLOGICAL

Single booster shot (3rd dose in Part A and 4th dose in Part B)

BNT162b2 (Part A); BNT162b2 (Part B)

Spikevax (mRNA-1273) BIOLOGICAL

Single booster shot (3rd dose in Part A and 4th dose in Part B)

mRNA-1273 (Part A); mRNA-1273 (Part B)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject is ≥75 years old.
• Prior to study entry the subject was vaccinated with BNT162b2, mRNA-1273 or ChAdOx-1-S (same vaccine product for 1st + 2nd dose)
• BNT162b2 + BNT162b2
• mRNA-1273 + mRNA-1273
• ChAdOx-1-S + ChAdOx-1-S
• ± 3 months since the second vaccine dose at time of enrolment for the planned 3rd vaccine dose in the trial. Vaccination status should be documented in the source data and captured in the eCRF.
• No contra-indication against any of the vaccine products in the trial.
• Written informed consent from subject has been obtained.

You may not qualify if:

• Primary vaccination performed with different vaccine products as sole (e.g., COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).
• Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
• Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to \>10 mg/day prednisolone.
• Participation in other interventional trials.
• Subjects unable to report solicited adverse events.
• Subject with any contraindications to the vaccines in the trial at randomisation. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.
• Use of drugs with significant interaction with the investigational product according to the SmPC or similar documents.
• Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation.
• Any current SARS-CoV-2 infection or proven in the preceding 3 months.
• Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator.
• Legally incapacitated persons.
• Persons held in an institution by legal or official order.
• Subject is ≥75 years old.
• Prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):
• BNT162b2 + BNT162b2 + BNT162b2

Sponsors & Collaborators

• Oliver Cornely, MD: lead
• VACCELERATE: collaborator
• European Commission: collaborator

Study Sites (9)

University Hospital Cologne

Cologne, 50931, Germany

Location

University Hospital Frankfurt

Frankfurt, 60590, Germany

Location

Hannover Medical School Hospital

Hanover, 30625, Germany

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Helse Bergen HF, Haukeland University Hospital

Bergen, 5021, Norway

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Reina Sofia University Hospital

Córdoba, 14004, Spain

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

Biodonostia Health Research Institute

San Sebastián, 20014, Spain

Location

Related Publications (1)

• Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.

  PMID: 36209129 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Prof. Dr. med. Oliver A. Cornely
• Organization: University Hospital Cologne

oliver.cornely@uk-koeln.de

0049 221 478 85523

Study Officials

• Oliver A Cornely, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding is foreseen in this trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Coordinating Investigator

Model Details: This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a third (first booster, Part A) or fourth vaccine dose (second booster, Part B) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 16, 2021
• Study Start: November 8, 2021
• Primary Completion: October 1, 2022
• Study Completion: September 13, 2023
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.
• Access Criteria: To be announced.

Locations

DE (3); NO (1); LI (1); ES (4)