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Virus Therapy

Ad26.COV2.S for COVID-19 Prevention

Phase 1 & 2

Waitlist Available

Research Sponsored by Janssen Vaccines & Prevention B.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 38 months

Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of two different doses of a vaccine for COVID-19 in adults aged 18-55 and 65+. The vaccine will be given as a single dose or two doses, with or without a booster vaccination.

Eligible Conditions

COVID-19 Prevention

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 38 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 38 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 38 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vaccination

Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination

Vaccination

+14 more

Secondary outcome measures

Cohorts 1, 2, and 3: Number of Participants With SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA)

Cohorts 1, 2, and 3: Number of Participants with SARS-CoV-2 Binding Antibodies Assessed by ELISA

Cohorts 1, 2, and 3: Number of Participants with T-helper (Th)-1 and Th-2 Immune Responses as Assessed by Flow Cytometry

+2 more

Side effects data

From 2023 Phase 3 trial • 44325 Patients • NCT04505722

Headache

Chills

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Ad26.COV2.S

Placebo

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

Participants (good or stable health adults aged >=65 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was >=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose or if they are not eligible for ad-hoc booster dose, then they will be asked to continue to be followed in this study.

Group II: Cohort 2bExperimental Treatment2 Interventions

Participants(healthy adults aged >=18 to <=55 years)will receive Ad26.COV2.S in primary regimen or matching Placebo on Day 1 and 57,followed by booster vaccination at 8 or 14 months (that is, 6 or 12 months after completion of primary regimen)with same dose or matching Placebo.At unblinding visit,post EUA,conditional licensure,or approval for single dose regimen of Ad26.COV2.S vaccine,participants initially receiving placebo will be offered to receive single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination.All eligible participants who have previously received any COVID-19 vaccination(as primary regimen or additional dose)if last vaccination was >= 6 months ago,will be offered to receive single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible for ad hoc booster dose will continue to receive booster vaccination.

Group III: Cohort 2aExperimental Treatment2 Interventions

Participants (healthy adults aged >=18 to <=55 years) will receive Ad26.COV2.S as single vaccination in the primary regimen or matching Placebo on Day 1, followed by booster vaccination at 6 or 12 months with same dose or matching Placebo. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine and who are not willing to receive single dose of Ad26.COV2.S vaccine will continue to receive booster vaccination. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was >= 6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S and who are not willing to receive single ad hoc booster dose of Ad26.COV2.S or are not eligible to receive the ad hoc booster dose will continue to receive booster vaccination.

Group IV: Cohort 1bExperimental Treatment2 Interventions

Participants (healthy adults aged >=18 to <= 55 years) will receive Ad26.COV2.S as a single vaccination in the primary regimen or matching Placebo on Day 1 and Day 57. At unblinding visit, post EUA, conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received any COVID-19 vaccination (as primary regimen or additional dose) if the last vaccination was >=6 months ago will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.

Group V: Cohort 1aExperimental Treatment2 Interventions

Participants (healthy adults aged greater than or equal to (>=)18 to less than or equal to (<=) 55 years) will receive Ad26.COV2.S at 2 dose levels, as a single dose or 2 dose schedule with an 8-week interval or matching Placebo on Day 1 and Day 57. At unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen of Ad26.COV2.S vaccine, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S. If they choose not to receive Ad26.COV2.S they will be asked to continue to be followed in this study. All eligible participants who have previously received coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) if the last vaccination was >=6 months ago, will be offered to receive a single ad hoc booster dose of Ad26.COV2.S. If they choose not to receive ad-hoc booster dose they will be asked to continue to be followed in this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Ad26.COV2.S

2021

Completed Phase 3

~84050

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor

55 Previous Clinical Trials

1,133,263 Total Patients Enrolled

Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.

47 Previous Clinical Trials

134,471 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the objective of this medical experiment?

"This trial will assess the primary outcome of adverse events occurring from first vaccination to six months after second vacciantion in Cohort 2. Secondary measures include SARS-CoV-2 binding antibody levels, platelet count given ad hoc booster vaccine and 28 days later, as well as Th1/Th2 immune responses via flow cytometry post peptide stimulation of peripheral blood mononuclear cells (PBMCs) and intracellular staining."

Answered by AI

Is there a wide distribution of this experiment across Canada?

"This clinical trial is actively recruiting at 7 medical centres across the globe, including in Boston, Melbourne and Austin. It is recommended that participants select a site closest to them to reduce travel demands."

Answered by AI

How many participants are partaking in this medical experiment?

"At this juncture, no further participants are being recruited for the trial which was first made public on July 15th 2020. If you're looking to join a different study, there are currently 1,029 studies researching COVID-19 prevention and 8 trials involving Ad26.COV2.S actively enrolling patients."

Answered by AI

Are there any vacancies available in this experiment for participants?

"This trial has concluded its recruitment period; posted on July 15th 2020 and last updated November 22nd 2022. For other opportunities, 1029 clinical trials are presently looking for participants related to Covid-19 prevention while 8 studies require individuals enrolled in the Ad26.COV2.S programme."

Answered by AI

Is this scientific inquiry a pioneering endeavor?

"To date, 8 trails in 130 cities and 19 countries are using Ad26.COV2.S as a drug to be tested on patients. The first clinical trial of its kind was launched by Janssen Vaccines & Prevention B.V., with 1085 participants involved in Phase 1 & 2 approval stages back in 2020; since then, 18 324 more trials have been conducted worldwide."

Answered by AI

Have any other experiments been conducted that use Ad26.COV2.S as the subject?

"The Ad26.COV2.S vaccine was initially investigated by Universiteit Antwerpen - Centrum voor de Evaluatie van Vaccinaties (CEV) in 2020, with 18324 concluded studies to date and 8 ongoing trials based mainly out of Boston, Massachusetts."

Answered by AI

Recent research and studies

npj VaccinesJournal

Ad26 Vector-based COVID-19 Vaccine Encoding a Prefusion-stabilized Sars-cov-2 Spike Immunogen Induces Potent Humoral and Cellular Immune Responses

Bos, Rinke, Lucy Rutten, Joan E. M. van der Lubbe, Mark J. G. Bakkers, Gijs Hardenberg, Frank Wegmann, David Zuijdgeest, et al.. 2020. “Ad26 Vector-based COVID-19 Vaccine Encoding a Prefusion-stabilized Sars-cov-2 Spike Immunogen Induces Potent Humoral and Cellular Immune Responses”. Npj Vaccines. Springer Science and Business Media LLC. doi:10.1038/s41541-020-00243-x.

JamaJournal

Immunogenicity of the Ad26.cov2.s Vaccine for COVID-19

Stephenson, Kathryn E., Mathieu Le Gars, Jerald Sadoff, Anne Marit de Groot, Dirk Heerwegh, Carla Truyers, Caroline Atyeo, et al.. 2021. “Immunogenicity of the Ad26.cov2.s Vaccine for COVID-19”. Jama. American Medical Association (AMA). doi:10.1001/jama.2021.3645.

New England Journal of MedicineJournal

Interim Results of a Phase 1–2a Trial of Ad26.cov2.s Covid-19 Vaccine

Sadoff, Jerald, Mathieu Le Gars, Georgi Shukarev, Dirk Heerwegh, Carla Truyers, Anne M. de Groot, Jeroen Stoop, et al.. 2021. “Interim Results of a Phase 1–2a Trial of Ad26.cov2.s Covid-19 Vaccine”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2034201.

npj VaccinesJournal