Clinical Trials Register

Summary
EudraCT Number:	2020-005801-14
Sponsor's Protocol Code Number:	VAC31518COV3003
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-12-30
Trial results	View 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

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-005801-14

A.3

Full title of the trial

A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults

A.3.1

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

A Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedules in Healthy Adults

A.4.1

Sponsor's protocol code number

VAC31518COV3003

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	Janssen Vaccines & Prevention B.V.
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Janssen Vaccines & Prevention B.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen Research & Development
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 20
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.com

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	No
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.3.1	Product name	Ad26.COV2.S
D.3.2	Product code	VAC31518
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not available
D.3.9.2	Current sponsor code	VAC31518
D.3.9.3	Other descriptive name	Ad26.COV2.S
D.3.9.4	EV Substance Code	SUB208328
D.3.10	Strength
D.3.10.1	Concentration unit	billion organisms/ml billion organisms/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	Yes
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

Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)

E.1.1.1

Medical condition in easily understood language

Healthy Volunteers (Prevention of COVID-19)

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084465
E.1.2	Term	COVID-19 vaccination
E.1.2	System Organ Class	100000004865

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 demonstrate non-inferiority (NI) in sequential order:
• 1-dose 9x10^10 vp vs 1-dose 5x10^10 vp (release titer)
• 1-dose 7x10^10 vp vs 1-dose 5x10^10 vp
• 1-dose 3.5x10^10 vp vs 1-dose 5x10^10 vp
• 1-dose 2.5x10^10 vp vs 1-dose 5x10^10 vp
• 1 dose 1.25x10^10 vp vs 1-dose 5x10^10 vp
To demonstrate NI in sequential order:
• 2-doses 9x10^10 vp vs 1-dose 5x10^10 vp
• 2-doses 9x10^10 vp vs 2-doses 5x10^10 vp
• 2-doses 7x10^10 vp vs 1-dose 5x10^10 vp
• 2-doses 7x10^10 vp vs 2-doses 5x10^10 vp
• 2-doses 3.5x10^10 vp vs 1-dose 5x10^10 vp
• 2-doses 3.5x10^10 vp vs 2-doses 5x10^10 vp
•NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 1 dose of Ad26.COV2.S 5x10^10 vp
•NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp
•NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 1-dose of Ad26.COV2.S 5x10^10 vp
•NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp

E.2.2

Secondary objectives of the trial

1.To assess the humoral immune response and durability to Ad26.COV2.S across all groups, at all blood collection timepoints.
2.To assess the seroconversion rate to 1 dose or 2 doses of Ad26.COV2.S across all groups, at all blood collection timepoints.
3.To assess the safety and reactogenicity of Ad26.COV2.S administered at several dose levels.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Participant must sign an ICF indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
2. Participant is willing and able to adhere to the prohibitions and restrictions specified in this protocol.
3. Participant is 18 to 55 years of age, inclusive, on the day of signing the ICF.
4. Participant must have a BMI <35.0 kg/m2.
5. Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs.
6. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
7.Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.

E.4

Principal exclusion criteria

1.Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
2.Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
3.Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine).
4.Participant has abnormal function of the immune system resulting from:
a.Clinical conditions (eg, autoimmune disease, potential immune mediated disease or known or suspected immunodeficiency, chronic kidney disease [with dialysis]) expected to have an impact on the immune response of the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.
b.Chronic or recurrent use of systemic corticosteroids within 6 months before administration of study vaccine and during the study.
Note: Ocular, topical or inhaled steroids are allowed.
c.Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of study vaccine and during the study.
5.Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
6.Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis.
7.Participant received treatment with immunoglobulins in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
8.Participant received or plans to receive:
c.Licensed live attenuated vaccines – within 28 days before or after planned administration of the first or subsequent study vaccinations
d.Other licensed (not live) vaccines – within 14 days before or after planned administration of the first or subsequent study vaccinations.
9.Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational Ig or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study.
10.Participant is a woman who is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine.
11.Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
12.Participant had surgery requiring hospitalization (defined as inpatient stay for longer than 24 hours or overnight stay), within 12 weeks before vaccination, or will not have fully recovered from surgery requiring hospitalization, or has surgery requiring hospitalization planned during the time the participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
13.Participant has a contraindication to IM injections and blood draws eg, bleeding disorders.
14. Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor.
15.Participant has chronic active hepatitis B or hepatitis C infection per medical history.
16. History of capillary leak syndrome.

E.5 End points

E.5.1

Primary end point(s)

•Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 28 days after vaccination
•NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 28 days post-dose 1, using a NI margin of 2/3 for the GMC ratio (GMC 9x10^10 vp, 7x10^10 vp, 3.5x10^10 vp, 2.5x10^10 [or 1.25x10^10 vp]/GMC 5x10^10 vp)
•Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 14 days after vaccination 2
•NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 14 days post-dose 2 (9x10^10 vp, 7x10^10 vp, 3.5x10^10 vp, 2.5x10^10 vp or 1.25x10^10 vp) and 28 days post-dose 1 or 14 days post-dose 2 (5x1010 vp), using a NI margin of 2/3 for the GMC ratio (GMC 9x10^10 vp, 7x10^10 vp, 3.5x10^10 vp 2.5x10^10 [or 1.25x10^10 vp]/GMC 5x10^10 vp)

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days after vaccination

E.5.2

Secondary end point(s)

•Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA
•Antibody GMCs (S-ELISA)
•The proportion of subjects achieving seroconversion of serum antibody against the SARS-CoV-2 S protein by S-ELISA
•Solicited local and systemic AEs for 7 days after each vaccination
•Unsolicited AEs for 28 days after each vaccination
•SAEs throughout the study (from first vaccination until end of the study)
•Adverse event of special interest (AESIs [from first vaccination until end of the study])
•MAAEs (until 6 months post-dose 2)
•AEs leading to study discontinuation (during the entire study) for all participants following vaccination

E.5.2.1

Timepoint(s) of evaluation of this end point

until 6 months post vaccination

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

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

Immunogenicity and end of shelf life

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

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

Yes

E.8.2.3.1

Comparator description

Different doses of Ad26.COV2.S

E.8.2.4

Number of treatment arms in the trial

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

Germany

Poland

E.8.7

Trial has a data monitoring committee

Yes

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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:

1350

F.1.3

Elderly (>=65 years)

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

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Subjects with stable and well-controlled comorbidities

F.4 Planned number of subjects to be included

F.4.1

In the member state

570

F.4.2

For a multinational trial

F.4.2.1

In the EEA

750

F.4.2.2

In the whole clinical trial

1350

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)

Participants in groups who received a dose level of Ad26.COV2.S that did not meet non-inferiority may be offered a booster of the Ad26.COV2.S study vaccine at the licensed/authorized dose after primary results are available (post-dose 2).

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

2021-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-12

P. End of Trial
P.	End of Trial Status	Completed

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