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COVID-19 Vaccine for COVID-19 (VAT00002 Trial)

Q: Are there any clinical vacancies for this treatment?

<p>According to the latest update on clinicaltrials.gov, this study is not recruiting patients. The trial was first posted on February 24th, 2021 and was most recently updated on July 11th, 2022. There are 1134 other trials that are actively looking for patients.</p>

Phase 2 & 3

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

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

Must have

Female participants must not be pregnant or breastfeeding

Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 22, day 36, day 78, day 134, day 202, day 292 and day 387

Awards & highlights

VAT00002 Trial Summary

This trial is testing two possible COVID-19 vaccines to see if they are safe and effective.

Who is the study for?

Adults aged 18+ who are not pregnant or breastfeeding can join. They must agree to use contraception, have a negative pregnancy test before doses, and be willing to attend all visits. Participants should have completed an approved COVID-19 vaccine series at least 4 months ago but no more than 10 months prior. Those with stable HIV on treatment can join; however, individuals with severe allergies to vaccine components or certain medical conditions cannot participate.Check my eligibility

What is being tested?

The trial is testing various formulations of SARS-CoV-2 recombinant protein vaccines with adjuvants as primary and booster shots against COVID-19. It aims to assess safety, measure antibody responses after vaccination, compare immune response from boosters to initial vaccinations, and monitor occurrences of symptomatic COVID-19 post-vaccination.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site (like pain or swelling), general symptoms like fever or fatigue, muscle aches, headaches and potentially allergic reactions. The severity of these side effects varies among individuals.

VAT00002 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or breastfeeding.

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I do not plan to get a COVID-19 vaccine from the first dose to 3 weeks after the second dose, even though it's recommended.

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I am a woman who cannot have children because I am post-menopausal for at least 1 year or I have had surgery to become sterile.

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I agree to use birth control or practice abstinence.

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I am 18 years old or older.

VAT00002 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 22, day 36, day 78, day 134, day 202, day 292 and day 387

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 22, day 36, day 78, day 134, day 202, day 292 and day 387

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 22, day 36, day 78, day 134, day 202, day 292 and day 387 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

2-fold rise and 4-fold-rise in neutralization antibody titer

Neutralizing antibody titer at Day 1

Neutralizing antibody titer at Day 1 (pre-booster injection)

+12 more

Secondary outcome measures

2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points

2-fold rise and 4-fold-rise in neutralization antibody titer at all pre-defined time points post-booster and booster comparator injection

2-fold-rise and 4-fold rise in binding antibody concentration

+17 more

VAT00002 Trial Design

12Treatment groups

Experimental Treatment

Active Control

Group I: Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccineExperimental Treatment2 Interventions

Participants who were vaccinated 4 to < 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine

Group II: Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccineExperimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Group III: Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccineExperimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine

Group IV: Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccineExperimental Treatment2 Interventions

Participants who were previously vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine

Group V: Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1Experimental Treatment1 Intervention

2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22

Group VI: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3Experimental Treatment1 Intervention

2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22

Group VII: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2Experimental Treatment1 Intervention

2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22

Group VIII: Cohort 2 - Booster Exploratory 4Experimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Group IX: Cohort 2 - Booster Exploratory 3Experimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Group X: Cohort 2 - Booster Exploratory 2Experimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Group XI: Cohort 2 - Booster Exploratory 1Experimental Treatment1 Intervention

Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine

Group XII: Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccineActive Control2 Interventions

2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants

0 / 5Eligibility criteria met

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Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,064,067 Total Patients Enrolled

Sanofi Pasteur, a Sanofi CompanyLead Sponsor

407 Previous Clinical Trials

6,088,596 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,015,914 Total Patients Enrolled

Media Library

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 Clinical Trial Eligibility Overview. Trial Name: NCT04762680 — Phase 2 & 3

Coronavirus Research Study Groups: Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3, Supplemental Cohort 2 - Booster Bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine, Cohort 2 - Booster Exploratory 3, Supplemental Cohort 1 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine, Cohort 2 - Booster Exploratory 4, Supplemental Cohort 2 - Booster Monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine, Cohort 2 - Booster Exploratory 2, Supplemental Cohort 2 - Booster Monovalent (D614)-AS03 SARS-CoV-2 vaccine, Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine, Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1, Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2, Cohort 2 - Booster Exploratory 1

Coronavirus Clinical Trial 2023: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 Highlights & Side Effects. Trial Name: NCT04762680 — Phase 2 & 3

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762680 — Phase 2 & 3

Coronavirus Patient Testimony for trial: Trial Name: NCT04762680 — Phase 2 & 3

Frequently Asked Questions

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

Are there any clinical vacancies for this treatment?

"According to the latest update on clinicaltrials.gov, this study is not recruiting patients. The trial was first posted on February 24th, 2021 and was most recently updated on July 11th, 2022. There are 1134 other trials that are actively looking for patients."

Answered by AI