Serial antibody progression after 3rd dose of vaccination in thoracic organ transplant patients with inadequate immune response after dual protective vaccination against SARS-CoV-2 coronavirus

Serial antibody progression after 3rd dose of vaccination in thoracic organ transplant patients with inadequate immune response after dual protective vaccination against SARS-CoV-2 coronavirus - H/LTX-Cov19-3. Dosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028865

Enrollment

400

Registered

2022-04-26

Start date

2021-09-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart transplantation coronavirus disease

Interventions

Group 1: Patients who have undergone heart transplantation and have received a double vaccination against SARS-COV-2 are recommended to receive a third vaccination dose if their antibody titres are lo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women after thoracic organ transplantation (heart, lung, combined heart-lung) with a minimum age of 18 years who have received a first and second vaccination against SARS-CoV-2. Precondition: Present signed and dated study consent.

Exclusion criteria

Exclusion criteria: Acute infections; Medical complications that could increase the risk of vaccination in the opinion of the clinicians treating the patient and/or the physicians responsible for the study, in particular o Rejection reactions in the past 3 months with the need for augmentation of standard.

Design outcomes

Primary

Measure	Time frame
Anti-SARS-CoV-2 IgG antibody (Abbott quantitative SARS-CoV-2 antibody assay, traceable to WHO standard) 21-28 days after 3rd vaccination dose	—

Secondary

Measure	Time frame
1st analysis of SARS-CoV-2 antibodies: Neutralising antibodies 21-28 days after 3rd vaccination dose. In case of detectable SARS-CoV-2 antibodies 21-28 days after 3rd vaccination dose: o SARS-CoV-2 antibodies 60, 120 and 180 days after 3rd vaccination dose to detect long-term immunity. o Neutralising antibodies 60, 120 and 180 days after 3rd vaccination dose to assess long-term immunity 2. analysis of T-cell immunity. INF-? release from cells stimulated with SARS-CoV-2 specific peptides, analysed on fresh blood from a sub-collective of patients, 21-28 days after 3rd vaccination dose. 3. tolerability, exclusion of relevant side effects o Analysis of short-term tolerability (telephone study visit 5-7 days after 3rd vaccination dose) o Evaluation of a patient questionnaire on the tolerability of the 3rd vaccination dose (incl. data on the tolerability of the previous standard vaccination doses 1 and 2), completed 21-28 days after the 3rd vaccination dose.	—

Measure

Time frame

1st analysis of SARS-CoV-2 antibodies: Neutralising antibodies 21-28 days after 3rd vaccination dose. In case of detectable SARS-CoV-2 antibodies 21-28 days after 3rd vaccination dose: o SARS-CoV-2 antibodies 60, 120 and 180 days after 3rd vaccination dose to detect long-term immunity. o Neutralising antibodies 60, 120 and 180 days after 3rd vaccination dose to assess long-term immunity 2. analysis of T-cell immunity. INF-? release from cells stimulated with SARS-CoV-2 specific peptides, analysed on fresh blood from a sub-collective of patients, 21-28 days after 3rd vaccination dose. 3. tolerability, exclusion of relevant side effects o Analysis of short-term tolerability (telephone study visit 5-7 days after 3rd vaccination dose) o Evaluation of a patient questionnaire on the tolerability of the 3rd vaccination dose (incl. data on the tolerability of the previous standard vaccination doses 1 and 2), completed 21-28 days after the 3rd vaccination dose.

—

Countries

Germany

Contacts

Public ContactHeike Windhagen

Herz- und Diabeteszentrum NRW, Klinik für Thorax- u. Kardiovaskularchirurgie, Universitätsklinikum der Ruhr Universität Bochum

hwindhagen@hdz-nrw.de05731-97-1907

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026