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NCT05160766 | COMPLETED | Vaccination Reaction

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

Oliver Cornely, MD

Information provided by (Responsible Party):

Oliver Cornely, MD

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 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 elderly, a usually neglected population. Additional vaccines and extended follow-up visits can be added through amendments of this sub-protocol. As stated in the EU-COVAT master protocol, this trial, i.e., the EU-COVAT-1_AGED study, implements a specific safety monitoring strategy (see below). Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol

Condition or disease

Vaccination Reaction

COVID-19

Vaccination; Infection

Intervention/treatment

Comirnaty(BTN162b2)

Spikevax (mRNA-1273)

Phase

PHASE2

Detailed Description:

PLEASE NOTE: This protocol refers to Part B of the clinical trial in which new accruals are randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273. Part A of the present trial in which individuals received a 3rd vaccination (first booster) is closed to further recruitment as of January 13, 2022. With the massive roll-out of booster campaigns throughout Europe, Part A was abandoned because of a poor recruitment rate. Individuals in Part A are followed-up as specified in protocol version V04_0 and analyzed descriptively, the statistical analysis plan will be adapted accordingly. Randomisation in Part B Subjects who - prior to study entry - got a primary vaccination series and 3rd vaccination dose 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 will receive a 4th vaccination dose with an allocation ratio of 1:1 to either BNT162b2 or mRNA-1273. Accordingly, there are 6 cohorts/arms (equalling 12 intervention arms). All individuals who were randomized to BNT162b2 represent Group 1, all individuals who were randomized to mRNA-1273 represent Group 2.

Study Type : INTERVENTIONAL
Estimated Enrollment : 323 participants
Masking : NONE
Masking Description : No blinding is foreseen in this trial
Primary Purpose : PREVENTION
Official Title : A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)
Actual Study Start Date : 2021-11-08
Estimated Primary Completion Date : 2022-10-01
Estimated Study Completion Date : 2023-09-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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
    • * 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.
Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

Location Details

NCT05160766

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany,

University Hospital Cologne

Cologne, Germany, 50931

Not yet recruiting

Germany,

University Hospital Frankfurt

Frankfurt, Germany, 60590

Not yet recruiting

Germany,

Hannover Medical School Hospital

Hannover, Germany, 30625

Not yet recruiting

Ireland,

Cork University Hospital

Cork, Ireland, Wilton

Not yet recruiting

Ireland,

Royal College of Surgeons in Ireland

Dublin, Ireland, Dublin 09

Not yet recruiting

Ireland,

St. Vincent's University Hospital

Dublin, Ireland, Dublin 4

Not yet recruiting

Ireland,

Mother of Mercy University Hospital

Dublin, Ireland, Dublin 7

Not yet recruiting

Ireland,

St. James's Hospital

Dublin, Ireland, Dublin 8

Not yet recruiting

Lithuania,

Inlita JSC

Vilnius, Lithuania, 08406

Not yet recruiting

Lithuania,

Vilnius University Hospital Santaros Clinic

Vilnius, Lithuania, 08661

Not yet recruiting

Norway,

Health Bergen HF, Haukeland University Hospital

Bergen, Norway, 5021

Not yet recruiting

Spain,

Germans Trias i Pujol University Hospital

Badalona, Spain, 08916

Not yet recruiting

Spain,

Bellvitge University Hospital

Barcelona, Spain, 08907

Not yet recruiting

Spain,

Reina Sofia University Hospital

Córdoba, Spain, 14004

Not yet recruiting

Spain,

La Paz University Hospital

Madrid, Spain, 28046

Not yet recruiting

Spain,

Biodonostia Health Research Institute

San Sebastian, Spain, 20014