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

NCT ID: NCT05160766

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2023-09-13

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.

Detailed Description

Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.

The initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:

Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 or mRNA-1273 & mRNA-1273 or ChAdOx-1-S & ChAdOx-1-S.

For the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:

Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 & BNT162b2 or BNT162b2 & BNT162b2 & mRNA-1273 or mRNA-1273 & mRNA-1273 & mRNA-1273 or mRNA-1273 & mRNA-1273 & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & mRNA-1273.

Conditions

Prevention of COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BNT162b2 (Part A)

vaccination with BNT162b2 as 3rd vaccination

Group Type: ACTIVE_COMPARATOR

Comirnaty (BTN162b2)

Intervention Type: BIOLOGICAL

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

mRNA-1273 (Part A)

vaccination with mRNA-1273 as 3rd vaccination

Group Type: ACTIVE_COMPARATOR

Spikevax (mRNA-1273)

Intervention Type: BIOLOGICAL

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

BNT162b2 (Part B)

vaccination with BNT162b2 as 4th vaccination

Group Type: ACTIVE_COMPARATOR

Comirnaty (BTN162b2)

Intervention Type: BIOLOGICAL

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

mRNA-1273 (Part B)

vaccination with mRNA-1273 as 4th vaccination

Group Type: ACTIVE_COMPARATOR

Spikevax (mRNA-1273)

Intervention Type: BIOLOGICAL

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

Interventions

Comirnaty (BTN162b2)

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

Intervention Type: BIOLOGICAL

Spikevax (mRNA-1273)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 9 ± 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.

• 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

BNT162b2 + BNT162b2 + mRNA-1273

mRNA-1273 + mRNA-1273 + mRNA-1273

mRNA-1273 + mRNA-1273 + BNT162b2

ChAdOx-1-S + ChAdOx-1-S + BNT162b2

ChAdOx-1-S + ChAdOx-1-S + mRNA-1273

The last dose of the above listed vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.

• Written informed consent from subject has been obtained.

Exclusion Criteria

• 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.

• Prior to study entry the subject got vaccinated with a regimen not included in the list given above.
• Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
• Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
• 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.
• Subject simultaneously participates in another clinical trials or has participated in the past 30 days.
• Subjects unable to report solicited adverse events.
• Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VACCELERATE

UNKNOWN

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

Oliver Cornely, MD

OTHER

Sponsor Role: lead

Responsible Party

Oliver Cornely, MD

Principal Coordinating Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oliver A Cornely, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

University Hospital Cologne

Cologne, , Germany

University Hospital Frankfurt

Frankfurt, , Germany

Hannover Medical School Hospital

Hanover, , Germany

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Helse Bergen HF, Haukeland University Hospital

Bergen, , Norway

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Reina Sofia University Hospital

Córdoba, , Spain

La Paz University Hospital

Madrid, , Spain

Biodonostia Health Research Institute

San Sebastián, , Spain

Countries

Germany; Lithuania; Norway; Spain

References

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.

Reference Type: DERIVED

PMID: 36209129 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-004526-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

uni-koeln-4602

Identifier Type: OTHER

Identifier Source: secondary_id

EU-COVAT-1_AGED

Identifier Type: -

Identifier Source: org_study_id