- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05470803
An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine, mRNA Covid-19 Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine as 4th Dose in Individuals Primed/ Boosted With Various Regimens
July 21, 2022 updated by: D'Or Institute for Research and Education
An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine (AstraZeneca/Fiocruz), mRNA Covid-19 (Comirnaty, Pfizer/Wyeth) Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019-Clover) as 4th Dose in Individuals Primed/ Boosted With Various Regimens
This is an exploratory phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of various SARS-CoV-2 vaccines.
There will be 04 study cohorts, that have previously received 03 doses of the indicated vaccine (s), divided into 10 groups; and each one of the 10 study groups will receive the 4th dose.
This exploratory study will enroll up to 360 participants in 4 cohorts and a total of 10 groups: Cohort A (N=90), Cohort B (N= 90), Cohort C (N=150) and Cohort D (N=30).
In cohorts A-C participants will be randomized 1:1:1 to three different 4th dose regimens.
The number of proposed participants will provide a reasonable accurate descriptive summary of the safety and immunogenicity of the tested vaccination regimens.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sue A Clemens
- Phone Number: 55 (21) 3883-6000
- Email: pesquisaclinica@idor.org
Study Locations
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Rio De Janeiro, Brazil, 22211-230
- Hospital Gloria D'Or
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Contact:
- Ana Pittella, MD
- Phone Number: +55 (21) 3883-6000
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Principal Investigator:
- Ana Pittella, MD
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Rio Grande Do Norte
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Natal, Rio Grande Do Norte, Brazil
- Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN)
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SP
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São Paulo, SP, Brazil, 04038-001
- Crie Unifesp
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Contact:
- Lily Weckx, MD
- Phone Number: (11) 5576-4993
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Contact:
- Lily
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Principal Investigator:
- Lily Weckx, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥18 years of age. Participation of individuals >60 years will be limited to ≤ 10/ group.
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
Individuals are willing and able to give an informed consent, prior to screening.
- Individuals who received one of the following vaccination regimens 3 doses of Pfizer/ Wyeth; 3 doses of AstraZeneca/Fiocruz; or 2 doses of Sinovac/Butantan and 1 dose of AstraZeneca, or eventually 3 doses of Sinovac/Butantan; or 2 doses of AstraZeneca and 1 dose of Alum/CpG-adjuvanted 9 µg or 30 µg Clover SCB-2019 vaccine (participants of study TP-SCB-2019-002).
- Interval between last priming dose and 3rd dose minimum 3 months
- Interval between 3rd dose and 4th dose ≥ 4 months
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
Female participants are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
- Women of non-childbearing potential;
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to study vaccination. A confirmatory serum pregnancy test may be conducted at the investigator's discretion. They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the last study vaccination.
- Male participants must agree to employ acceptable contraception from the day of dose of the study vaccine until 6 months after the last dose of the study vaccine/comparator and also refrain from donating sperm during this period.
Exclusion Criteria:
- Individuals with fever >37.5°C (axillary), or any acute illness at baseline (Day 0) or within 3 days prior to randomization. Participants meeting this criterion may be rescheduled within the relevant window. Febrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Individuals who have received more than 3 combined doses of any licensed or experimental COVID vaccine prior to Day 0 or plan to receive COVID-19 vaccine during the study period, a drug for COVID-19 prevention or treatment (e.g., drugs, monoclonal antibodies, such as Rituximab or any other anti-CD20 monoclonal antibodies during the study period.).
- Receipt of any authorized or investigational COVID-19 vaccine prior to Day 0 except for the 03 doses of Pfizer/ Wyeth; 03 doses of AstraZeneca/Fiocruz; or two doses of Sinovac/Butantan and 01 dose of Pfizer/Wyeth, or eventually 03 doses of Sinovac/Butantan; or two doses of AstraZeneca and one dose of Clover SCB-2019 ≥ 4 months before enrollment in this study.
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines (Pfizer/Wyeth, AstraZeneca/Fiocruz, CpG 1018, aluminum, or SCB-2019 components as outlined in the latest summary of product characteristics for Pfizer/Wyeth, AstraZeneca/Fiocruz and the IB for SCB-2019.
- Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
- Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- Individuals who received treatment with immunosuppressive therapy in the last 90 days, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study period. If a short-term course of systemic corticosteroid immunosuppressive dose has been used for the treatment of acute illness, the participant should not be included in the study until corticosteroid therapy has been discontinued for at least 15 days prior to first study vaccination. If the participant has used an immunosuppressive dose of a depot corticosteroid, intra-muscular or intra-articular, they must wait 60 days for inclusion in the study. Inhaled or nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Individuals with autoimmune diseases, except: Hashimoto's thyroiditis, vitiligo, psoriasis, lupus discord and alike; HIV-positive individuals and/or on HIV treatment.
- Individuals who have received any other investigational product within 30 days prior to Day 0 or intend to participate in another clinical study at any time during the conduct of this study.
- Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 28 days after the last vaccination.
- Individuals who have received treatment with Rituximab or any other anti-CD20 monoclonal antibodies within 9 months prior to Day 0 or planned during the study period.
- Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period.
- Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
- Pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A: 03 doses Pfizer/Wyeth
Group 1: AstraZeneca/Fiocruz Group 2: Pfizer/Wyeth Group 3: Clover SCB-2019
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4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
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Experimental: Cohort B: 03 doses AstraZeneca/Fiocruz
Group 4: AstraZeneca/Fiocruz Group 5: Pfizer/Wyeth Group 6: Clover SCB-2019
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4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
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Experimental: Cohort C: 03 doses Sinovac/Butantan or 02 doses and 01 dose AstraZeneca/Fiocruz
Group 7: AstraZeneca/Fiocruz Group 8: Pfizer/Wyeth Group 9: Clover SCB-2019
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4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
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Experimental: Cohort D: 02 doses AstraZeneca/Fiocruz and 01 dose Alum/CpG adjuvanted 9 or 30 µg Clover SCB-2019
Group 10: Clover SCB-2019
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4th dose of SARS-CoV-2 vaccine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: 28 days after the administration of a 4th dose of anti-COVID-19 vaccines
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VNA positivity and Anti-Spike IgG antibody titers (ELISA) for several strains of SARS-CoV2 (Wuhan, Delta, Omicron BA.1, optionally BA.4/5 and/or BA.1.12)
at baseline (day 0) and day 28 after 4th dose.
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28 days after the administration of a 4th dose of anti-COVID-19 vaccines
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: 84 days after the administration of a 4th dose of anti-COVID-19 vaccines
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VNA positivity and Anti-Spike IgG antibody titers (ELISA) for several strains of SARS-CoV-2 (Wuhan, Delta, Omicron BA.1, optionally BA.4/5 and/or BA.1.12)
at baseline (day 0) and day 84 after 4th dose.
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84 days after the administration of a 4th dose of anti-COVID-19 vaccines
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Occurrence of SAEs, AESIs and severe unsolicited AEs
Time Frame: At days 28 and 84
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Occurrence of SAEs, AESIs and severe unsolicited AEs
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At days 28 and 84
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Safety: Total and severe local / systemic solicited AEs
Time Frame: At days 0 to 7
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Total and severe local / systemic solicited AEs
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At days 0 to 7
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Number of SARS-CoV-2 infection cases
Time Frame: At days 28 and 84
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Occurrence of confirmed episodes of COVID-19 by RT-PCR or lateral flow test
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At days 28 and 84
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2022
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
July 20, 2022
First Submitted That Met QC Criteria
July 21, 2022
First Posted (Actual)
July 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 22, 2022
Last Update Submitted That Met QC Criteria
July 21, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP-SCB-2019-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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