HealthyPhase 1NCT04894305
A Study of Ad26.COV2.S in Healthy Adults (COVID-19)
A Phase 1 study testing Ad26.COV2.S in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ad26.COV2.S
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2021to 8 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must sign an informed consent form (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
- 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 coronavirus disease-2019 (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
- All participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately on the day of and prior to study vaccine administration
- Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the study vaccine
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Who cannot join
- 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)
- 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)
- Participant has a history of any neurological disorders or seizures including Guillain-barre syndrome, with the exception of febrile seizures during childhood
- Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis
- 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 study vaccine or has any plans to receive such treatment during the study
- Upper limit of body mass index (BMI) range should not be considered in participants with comorbidities that are or might be associated with an increased risk of progression to severe COVID-19. Participants may have hypertension of mild severity, as long as it is stable and medically controlled as defined by no change in medication over the past 6 months (except for issues of tolerability or use of similar drug with same mechanism of action, example, thiazides, beta blockers, alpha blockers at the same effective dose)
- Participant who is an employee of the sponsor, investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, including the family members of those employees or the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Observer-blind Study to Compare the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S at a Single Dose of 5*10^10 vp in 2 Different Volumes in Healthy Adults
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.
- Conditions
- Healthy
- Being tested
- Ad26.COV2.S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.COV2.SBiological
Also called JNJ-78436735, VAC31518
Ad26.COV2.S will be administered as IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Test Group): Ad26.COV2.S (0.3 mL) | Experimental | Participants will receive single dose Ad26.COV2.S 0.3 milliliter (mL) intramuscular (IM) injection on Day 1 in test group. Receives: Biological: Ad26.COV2.S |
| Group 2 (Reference Group): Ad26.COV2.S (0.5 mL) | Active comparator | Participants will receive single dose Ad26.COV2.S 0.5 mL IM injection on Day 1 in reference group. Receives: Biological: Ad26.COV2.S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Measured: Day 8 (7 days after vaccination)
Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination
Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Measured: Day 8 (7 days after vaccination)
Number of Participants with Unsolicited AEs for 28 Days After Vaccination
Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Measured: Day 29 (28 days after vaccination)
Number of Participants with AEs Leading to Study Discontinuation
Number of participants with AEs leading to study discontinuation will be reported.
Measured: Up to 6 months
Number of Participants with Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Measured: Up to 6 months
Number of Participants with Adverse Events of Special Interests (AESIs)
Number of participants with AESIs will be reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
Measured: Up to 6 months
S Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After Vaccination
Non-inferiority (NI) will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.
Measured: Day 29 (28 days after vaccination)
Secondary outcomes (3)
Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) S Protein Binding Antibody Concentrations as Measured by S-ELISA
SARS-CoV-2 S protein binding antibody concentrations as measured by S-ELISA will be reported.
Measured: Up to 6 months
Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers
Serological response to vaccination, as measured by VNA titers will be reported.
Measured: Up to 6 months
Geometric Mean Titers (GMTs) of Antibody
GMTs of antibody will be reported.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start25 May 2021
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894305
- Sponsor's protocol ID
- CR109013
- Other IDs
- 2021-001374-30, VAC31518COV1003
- Status last verified
- Dec 2021
- First submitted
- 18 May 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Observer-blind Study to Compare the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S at a Single Dose of 5*10^10 vp in 2 Different Volumes in Healthy Adults
- ClinicalTrials.gov ID
- NCT04894305
- Acronym / sponsor ID
- CR109013
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter [mL] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Test Group): Ad26.COV2.S (0.3 mL) | Experimental | Biological: Ad26.COV2.SParticipants will receive single dose Ad26.COV2.S 0.3 milliliter (mL) intramuscular (IM) injection on Day 1 in test group. |
| Group 2 (Reference Group): Ad26.COV2.S (0.5 mL) | Active comparator | Biological: Ad26.COV2.SParticipants will receive single dose Ad26.COV2.S 0.5 mL IM injection on Day 1 in reference group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must sign an informed consent form (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
- 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 coronavirus disease-2019 (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
- All participants of childbearing potential must: a) have a negative highly sensitive urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy test immediately on the day of and prior to study vaccine administration
- Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the study vaccine
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
Key exclusion criteria (7 listed)
- 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)
- 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)
- Participant has a history of any neurological disorders or seizures including Guillain-barre syndrome, with the exception of febrile seizures during childhood
- Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis
- 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 study vaccine or has any plans to receive such treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.COV2.SAlso: JNJ-78436735, VAC31518Ad26.COV2.S will be administered as IM injection. | Biological | Group 1 (Test Group): Ad26.COV2.S (0.3 mL), Group 2 (Reference Group): Ad26.COV2.S (0.5 mL) |
Primary outcome
Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination
Time frame: Day 8 (7 days after vaccination)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs. Participants will be asked to note in the diary occurrences of injection site pain/tenderness, erythema and swelling at the study vaccine injection site daily for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination
Time frame: Day 8 (7 days after vaccination)
Number of participants with solicited systemic AEs will be reported. Participants will be instructed on how to record daily temperature using a thermometer and also instructed to note signs and symptoms in the diary on a daily basis for 7 days after vaccination. Solicited systemic AEs are fatigue, headache, nausea, and myalgia.
Number of Participants with Unsolicited AEs for 28 Days After Vaccination
Time frame: Day 29 (28 days after vaccination)
Number of participants with unsolicited AEs will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Number of Participants with AEs Leading to Study Discontinuation
Time frame: Up to 6 months
Number of participants with AEs leading to study discontinuation will be reported.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 6 months
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Number of Participants with Adverse Events of Special Interests (AESIs)
Time frame: Up to 6 months
Number of participants with AESIs will be reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
S Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After Vaccination
Time frame: Day 29 (28 days after vaccination)
Non-inferiority (NI) will be assessed in terms of humoral immune response expressed by the GMCs of S-ELISA.
3 secondary outcomes
Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) S Protein Binding Antibody Concentrations as Measured by S-ELISA
Time frame: Up to 6 months
Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers
Time frame: Up to 6 months
Geometric Mean Titers (GMTs) of Antibody
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad26.COV2.S in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination (time frame: Day 8 (7 days after vaccination)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.