Clinical Trials Register

Summary
EudraCT Number:	2021-002245-15
Sponsor's Protocol Code Number:	CCM-RNT-202102
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-04-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2021-002245-15

A.3

Full title of the trial

A low-interventional study to investigate the efficacy and safety of SARS-CoV-2 vaccines in patients with rheumatic diseases.

Niedrig-interventionelle Studie zur Untersuchung der Effektivität und Sicherheit von SARS-CoV-2 Impfstoffen bei Patienten mit rheumatologischen Erkrankungen.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

An observational study to investigate the effectiveness and safety of Corona vaccines in patients with rheumatologic diseases.

Beobachtungsstudie zur Untersuchung der Wirksamkeit und Sicherheit von Corona-Impfstoffen bei Patienten mit rheumatologischen Erkrankungen

A.3.2

Name or abbreviated title of the trial where available

VACCIMMUN

A.4.1

Sponsor's protocol code number

CCM-RNT-202102

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Charité - Universitätsmedizin Berlin
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Charité - Universitätsmedizin Berlin
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Charité - Universitätsmedizin Berlin
B.5.2	Functional name of contact point	Rheumatologie Studienabteilung
B.5.3	Address:
B.5.3.1	Street Address	Charitéplatz 1
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	10117
B.5.3.4	Country	Germany
B.5.4	Telephone number	004930450513025
B.5.5	Fax number	004930450513986
B.5.6	E-mail	rheumastudien@charite.de

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Comirnaty
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Vaxzevria
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	COVID-19 Vaccine Janssen
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International NV
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	COVID-19 Vaccine Moderna
D.2.1.1.2	Name of the Marketing Authorisation holder	MODERNA BIOTECH SPAIN, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Auto Immune Rheumatic Diseases (AIRD) and patients without rheumatic autoimmune diseases (control group).

rheumatische Autoimmunerkrankungen und Patienten ohne rheumatische Autoimmunerkrankungen (Kontrollgruppe)

E.1.1.1

Medical condition in easily understood language

rheumatic diseases

rheumatische Erkrankungen

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10072736
E.1.2	Term	Rheumatic disorder
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To identify AIRD-specific variables that influence the expression and duration of vaccine protection following SARS-CoV-2 vaccination.

Ermittlung der AIRD-spezifischen Variablen, welche die Ausprägung und Dauer des Impfschutzes nach einer SARS-CoV-2 Impfung beeinflussen.

E.2.2

Secondary objectives of the trial

- investigation of the influence of the rheumatic disease and other relevant medical data, such as disease activity and drug therapy or B-Cell status, on the vaccination success.
- evaluation of the side effect profile of the vaccines, also with regard to the disease activity of the rheumatic disease and with regard to a possible induction of autoantibodies, e.g. ANA, RF, ACPA, anti-phospholipid-Ak.
- Determination of the extent and duration of vaccine protection after SARS-CoV-2 vaccination based on the occurrence of symptomatic or asymptomatic, laboratory detectable disease of COVID-19 of the SARS-CoV-2 virus.

- Erfassung des Einflusses der rheumatischen Erkrankung und weiterer relevanter medizinischer Daten wie der Krankheitsaktivität und der medikamentösen Therapie oder B-Zell Status auf den Impferfolg
- Erfassung des Nebenwirkungsprofils der Impfstoffe, auch in Hinblick auf die Krankheitsaktivität der rheumatischen Erkrankung und hinsichtlich einer eventuellen Induktion von Autoantikörpern, z.B. ANA, RF, ACPA, Anti-Phospholipid-Ak
- Ermittlung der Ausprägung und der Dauer des Impfschutzes nach einer SARS-CoV-2 Impfung anhand des Auftretens einer symptomatischen oder asymptomatischen, laboranalytisch nachweisbaren Erkrankung an COVID-19 des SARS-CoV-2 Virus

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. written consent for study participation.
2. if study entry after first vaccination: written informed consent for analysis of any archived blood samples.
3. males and females ≥ 18 years of age.
4. either arm 1 (AIRD patients): diagnosis of rheumatic autoimmune disease or arm 2 (control group): no diagnosis of rheumatic autoimmune disease.

1. Schriftliche Einwilligung zur Studienteilnahme
2. Wenn Studienbeginn nach erster Impfung: Schriftliche Einwilligung in die Analyse etwaiger archivierter Blutproben
3. Männer und Frauen ≥ 18 Lebensjahre
4. Entweder Arm 1 (AIRD Patienten): Diagnose einer rheumatischen Autoimmunerkrankung oder Arm 2 (Kontrollgruppe): keine Diagnose einer rheumatischen Autoimmunerkrankung

E.4

Principal exclusion criteria

1. persons not capable of giving consent
2. serious illnesses which, in the opinion of the investigator, preclude inclusion or continued observation (for example, tumor diseases requiring intensive chemotherapy).
3. individuals who are unable or unwilling to undergo multiple venipunctures because he/she is intolerant or has poor venous conditions.
4. persons who are admitted to an institution by court order or by order of the authorities.

1. Nicht einwilligungsfähige Personen
2. Schwerwiegende Erkrankungen, welche nach Einschätzung der Prüfärztin/des Prüfarztes einen Einschluss oder Weiterbeobachtung ausschließen (zum Beispiel Tumorerkrankungen, die eine intensive Chemotherapie erfordern).
3. Personen, welche nicht in der Lage oder nicht willens sind, sich mehrfachen Venenpunktionen zu unterziehen, weil er/sie nicht verträgt oder schlechte Venenverhältnisse hat.
4. Personen, welche per Gerichtsbeschluss oder auf Anordnung der Behörden in einer Einrichtung untergebracht sind.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of humoral and/or cellular vaccination response after SARS-Cov-2 vaccination.

Bestimmung der humoralen und/oder zellulären Impfantwort nach SARS-Cov-2 Impfung

E.5.1.1

Timepoint(s) of evaluation of this end point

3, 6, 12 and 24 months after initial vaccination as part of regular routine visits plus optional 14 days after each vaccination. If patients have received a third vaccination or even further vaccinations, the following dates are planned, in each case starting from the last vaccination carried out and up to the planned end of the study on 31-DEC-2023: Approximately 1/3/5/12/24 months after last vaccination.

3, 6, 12 und 24 Monate nach Erstimpfung im Rahmen der regulären Routine-Visiten plus optional 14 Tage nach jeder Impfung. Sofern Patienten eine dritte Impfung oder noch weitere Impfungen erhalten haben, sind folgende Termine vorgesehen, jeweils ausgehend von der zuletzt durchgeführten Impfung und bis zum geplanten Studienende am 31.12.2023: Zirka 1/3/5/12/24 Monate nach letzter Impfung.

E.5.2

Secondary end point(s)

- Recording of rheumatic diagnosis, immunosuppressive therapies, disease activity and possible relapses of the underlying rheumatologic disease after SARS-CoV-2 vaccination or B-cell status.
- Recording of the side effect profile after SARS-CoV-2 vaccination
- Determination of autoantibodies (e.g. ANA, RF, ACPA, anti-phospholipid-Ak) after SARS-CoV-2 vaccination
- Determination of the frequency of SARS-CoV-2 infections despite vaccination

- Erfassung der rheumatischen Diagnose, immunsuppressive Therapien, Krankheitsaktivität und möglicher Schübe der rheumatologischen Grunderkrankung nach SARS-CoV-2 Impfung oder B-Zell-Status
- Erfassung des Nebenwirkungsprofils nach SARS-CoV-2 Impfung
- Bestimmung von Autoantikörpern (z.B. ANA, RF, ACPA, Anti-Phospholipid-Ak) nach SARS-CoV-2 Impfung
- Bestimmung der Häufigkeit von SARS-CoV-2-Infektionen trotz Impfung

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Please note that this study does NOT include the administration of the vaccine. It is an observational study in which blood analysis during routine visits is the only intervention. The purpose of this study is to observe patients and their vaccination titers and their course, who were vaccinated at the vaccination center, at the general practitioner's office or at the workplace doctor's office.

Nochmal der Hinweis, dass in dieser Studie NICHT der Impfstoff verabreicht wird. Es ist eine Beobachtungsstudie, in der Blutanalysen im Rahmen von Routinebesuchen die einzige Intervention darstellen. Es ist das Ziel dieser Studie, Patienten und deren Impf-Titer sowie den Verlauf zu beobachten, welche sich im Impfzentrum, beim Hausarzt oder Betriebsarzt impfen ließen.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Beobachtungsstudie mit Forschungs-Blutentnahmen als einzige Intervention

Observational study with research blood sampling as the one and only intervention.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

300

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

450

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-04-30.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

250

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-25

P. End of Trial
P.	End of Trial Status	Ongoing

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