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COVID-19Phase 3NCT05470803

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

A Phase 3 study testing AstraZeneca/Fiocruz, Pfizer/Wyeth and Clover SCB-2019 in people with COVID-19, run by D'Or Institute for Research and Education at 3 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
AstraZeneca/Fiocruz, Pfizer/Wyeth and Clover SCB-2019
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
3 sitesBrazil
Study dates
Aug 2022to Aug 2023
Phase
Phase 3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Sue A Clemens contact

55 (21) 3883-6000

pesquisaclinica@idor.org

Brazil3 sites

  • Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN)

    Natal, Rio Grande do Norte

  • Hospital Gloria D'or

    Rio de Janeiro, 22211-230

    Ana Pittella, MD, +55 (21) 3883-6000

    Ana Pittella, MD

  • Crie Unifesp

    São Paulo, São Paulo, 04038-001

    Lily Weckx, MD, (11) 5576-4993

    Lily

Other trials in Brazil

About this study

Official title: 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.

Conditions
COVID-19
Being tested
AstraZeneca/Fiocruz, Pfizer/Wyeth, Clover SCB-2019
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AstraZeneca/FiocruzBiological

    4th dose of SARS-CoV-2 vaccine

  • Pfizer/WyethBiological

    4th dose of SARS-CoV-2 vaccine

  • Clover SCB-2019Biological

    4th dose of SARS-CoV-2 vaccine

Study groups in NCT05470803
Study groupRoleWhat they receive
Cohort A: 03 doses Pfizer/WyethExperimentalGroup 1: AstraZeneca/Fiocruz Group 2: Pfizer/Wyeth Group 3: Clover SCB-2019
Receives: Biological: AstraZeneca/Fiocruz; Biological: Pfizer/Wyeth; Biological: Clover SCB-2019
Cohort B: 03 doses AstraZeneca/FiocruzExperimentalGroup 4: AstraZeneca/Fiocruz Group 5: Pfizer/Wyeth Group 6: Clover SCB-2019
Receives: Biological: AstraZeneca/Fiocruz; Biological: Pfizer/Wyeth; Biological: Clover SCB-2019
Cohort C: 03 doses Sinovac/Butantan or 02 doses and 01 dose AstraZeneca/FiocruzExperimentalGroup 7: AstraZeneca/Fiocruz Group 8: Pfizer/Wyeth Group 9: Clover SCB-2019
Receives: Biological: AstraZeneca/Fiocruz; Biological: Pfizer/Wyeth; Biological: Clover SCB-2019
Cohort D: 02 doses AstraZeneca/Fiocruz and 01 dose Alum/CpG adjuvanted 9 or 30 µg Clover SCB-2019ExperimentalGroup 10: Clover SCB-2019
Receives: Biological: Clover SCB-2019

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity

    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.

    Measured: 28 days after the administration of a 4th dose of anti-COVID-19 vaccines

Secondary outcomes (1)

  1. Immunogenicity

    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.

    Measured: 84 days after the administration of a 4th dose of anti-COVID-19 vaccines

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study startAug 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of the following SARS-CoV-2 vaccines: recombinant COVID-19 vaccine -AstraZeneca/Fiocruz, mRNA covid-19 vaccine - Pfizer/Wyeth and SCB-2019-Clover.
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05470803
Sponsor's protocol ID
TP-SCB-2019-002
Status last verified
Jul 2022
First submitted
20 Jul 2022
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AstraZeneca/Fiocruz, Pfizer/Wyeth and Clover SCB-2019 in people with COVID-19, run by D'Or Institute for Research and Education at 3 sites in Brazil.

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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sue A Clemens (55 (21) 3883-6000, pesquisaclinica@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity (time frame: 28 days after the administration of a 4th dose of anti-COVID-19 vaccines). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470803.

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 Jul 2022.

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Clinical Trial NCT05470803 | AzTrials