COVID-19Phase 3NCT05812586
Assessment of Immunogenicity, Safety and Reactogenicity of a Booster Dose of Various COVID-19 Vaccine Platforms in Individuals Primed With Several Regimes.
A Phase 3 study testing SCB-2019/Clover, AstraZeneca/Fiocruz and Pfizer/Wyeth in people with COVID-19, run by D'Or Institute for Research and Education at 2 sites in Brazil.
Trial summary
SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it… 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?
- SCB-2019/Clover, AstraZeneca/Fiocruz and Pfizer/Wyeth
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 2 sitesBrazil
- Study dates
- 14 Mar 2023to Sep 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.
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- Individuals are willing and able to give an informed consent, prior to screening.
- Individuals must have completed vaccine priming, regardless of vaccine regimen. Primary vaccination and previous booster scheme data will be annotated as patient history.
- Interval between last dose and current study dose of a minimum of 4 months and a maximum of 24 months (to optimize candidate participation).
- 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.
Show all 9Show fewer
- 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 during the study, until 90 days after the study vaccination.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- 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.
- Self-reported confirmed COVID-19 infection, through RT-PCR or lateral flow test, in the last 4 weeks.
- Individuals who did not complete the primary vaccination scheme for any licensed COVID vaccine or plan to receive another COVID-19 vaccine (other than the study vaccines) 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.).
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis, venal or arterial thrombosis, thrombocytopenia) 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/Clover).
- Individuals with capillary leakage syndrome or thrombosis with thrombocytopenia syndrome
Show all 21Show fewer
- TTS (possibly associated with vaccination with the AstraZeneca/Fiocruz vaccine).
- Individuals who had pericarditis or myocarditis (these pathologies may be associated with the Pfizer/Wyeth vaccine, especially in young men).
- Individuals with known bleeding disorder that, 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 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.
- Breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
Natal, Rio Grande do Norte, 59025-050
Centro de Referência para Imunobiológicos Especiais - CRIE - UNIFESP
São Paulo, 04038-001
About this study
Official title: Covid-19 Vaccine Boosting in a Real World Setting: Exploratory Phase 3, Cohort Randomized, Single-blind, Multi-center Study to Evaluate the Safety and Immunogenicity of a Booster Dose of Various Covid-19 Vaccines in Fully Covid-19 Vaccine-primed Subjects Regardless of the Number of Prior Booster Dose(s) Received.
SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it is likely that the population will have to be repeatedly boosted until a "universal" Pan-Sarbecovirus vaccine is available.
SARS-CoV-2 protein subunit vaccine candidates have shown that, despite adjuvantation, their safety/reactogenicity profile seems to be preferable over mRNA or vectored vaccines, whilst inducing non-inferior immune responses (1,2).
Read more
In this regard, serious adverse events of special interest from mRNA vaccines seem to be have been substantially underestimated/underreported. In a preliminary analysis by an International consortium, the true incidence seems to be 1,250/million excess risk in vaccinees instead of the 1-2/million reported by the Department of Health and Human Services (3,4). Additionally, in a recent study, the Clover SCB-2019 protein subunit vaccine candidate has shown higher neutralizing antibodies titers against the omicron variant, when compared to an inactivated vaccine (data not published yet). Although Brazil has various vaccine platforms authorized for emergency use or licensed, such as mRNA vaccines, vector-based vaccines, inactivated vaccines, so far Brazil has no access to adjuvanted or non-adjuvanted protein-based vaccines.
This study will involve two vaccines registered in Brazil and a protein-based adjuvanted vaccine candidate, SCB-2019/Clover. Protein-based adjuvanted vaccines have the advantage of being from a known and licensed technology that can produce high quantities of vaccine at reasonable Costs of Goods. Protein-based adjuvanted vaccines have also been shown to be highly immunogenic, both in the context of COVID-19 (2,5) and other licensed vaccines (6), with long persistence of immunity and protection.
Over 80% of the Brazilian population above the age of 18 years have received a full primary vaccination and another 7% at least one dose of vaccine. The overall booster coverage is about 48% (64% of the adults) (7). Anvisa has authorized 1st and 2nd booster doses of various vaccines in line with the MoH policy which was last updated in March 2022. It can be speculated that, like in other geographies, a third booster will be recommended soon, especially to at risk populations and in the scenario of high circulation of the Omicron BA.5 strain.
This study will explore the immunogenicity, safety and reactogenicity of a booster dose of various platforms in fully primed individuals regardless of the number of booster doses they have received prior to the enrollment in the study.
This mimics the "real world scenario" at vaccination centers where individuals with different background vaccination schemes show up for "a booster". It would facilitate logistics of immunization substantially if vaccines for boosting, independent of the immunization status, could be interchangeable with respect to safety/reactogenicity and immunogenicity. This study will enroll fully-primed individuals (2 doses of either Pfizer mRNA or Oxford/AZ/Fiocruz or Sinovac/Butantan or 1 dose of Janssen vaccine) who have received their last vaccine dose at least 4 months prior to study entry and who have received either no booster, or 1 or 2 boosters. Individuals will be stratified in cohorts by number of boosters and then randomized to receive one of 3 booster vaccines (AstraZeneca/Fiocruz, Pfizer/Wyeth, SCB-2019/Clover).
- Conditions
- COVID-19
- Being tested
- SCB-2019/Clover, AstraZeneca/Fiocruz, Pfizer/Wyeth
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB-2019/CloverBiological
SCB-2019/Clover Vaccine
AstraZeneca/FiocruzBiological
AstraZeneca/Fiocruz Vaccine
Pfizer/WyethBiological
Pfizer/Wyeth Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SCB-2019/Clover | Experimental | Cohort A: complete primary immunization, no previous booster dose: SCB-2019/Clover Receives: Biological: SCB-2019/Clover |
| Group 2: AstraZeneca/Fiocruz | Experimental | Cohort A: complete primary immunization, no previous booster dose: AstraZeneca/Fiocruz Receives: Biological: AstraZeneca/Fiocruz |
| Group 3: Pfizer/Wyeth | Experimental | Cohort A: complete primary immunization, no previous booster dose: Pfizer/Wyeth Receives: Biological: Pfizer/Wyeth |
| Group 4: SCB-2019/Clover | Experimental | Cohort B: primary immunization plus one previous booster dose:SCB-2019/Clover Receives: Biological: SCB-2019/Clover |
| Group 5: AstraZeneca/Fiocruz | Experimental | Cohort B: primary immunization plus one previous booster dose: AstraZeneca/Fiocruz Receives: Biological: AstraZeneca/Fiocruz |
| Group 6: Pfizer/Wyeth | Experimental | Cohort B: primary immunization plus one previous booster dose: Pfizer/Wyeth Receives: Biological: Pfizer/Wyeth |
| Group 7: SCB-2019/Clover | Experimental | Cohort C: primary immunization plus two previous booster doses: SCB-2019/Clover Receives: Biological: SCB-2019/Clover |
| Group 8: AstraZeneca/Fiocruz | Experimental | Cohort C: primary immunization plus two previous booster doses: AstraZeneca/Fiocruz Receives: Biological: AstraZeneca/Fiocruz |
| Group 9: Pfizer/Wyeth | Experimental | Cohort C: primary immunization plus two previous booster doses: Pfizer/Wyeth Receives: Biological: Pfizer/Wyeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Anti-Spike IgG antibody positivity and titers (ELISA) for SARS-CoV-2 strains (Wuhan and BA.5)
Measured: At baseline (day 0)
Immunogenicity
Anti-Spike IgG antibody positivity and titers (ELISA) for SARS-CoV-2 strains (Wuhan and BA.5)
Measured: At day 28 after booster dose
Safety
Occurrence of SAEs, AESIs and severe unsolicited AEs
Measured: Throughout the study period, an average of 3 months
Secondary outcomes (3)
Immunogenicity
VNA positivity and titers for SARS-CoV-2 strains (Wuhan, BA.5)
Measured: At days 0, 28 and 84
Immunogenicity
Anti-Spike IgG antibody positivity and titers (ELISA) for SARS-CoV-2 strains (Wuhan, BA.5)
Measured: At day 84
Safety
Total and severe local/systemic solicited AEs
Measured: Over days 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start14 Mar 2023
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory phase 3, cohort randomized, single-blind, multi-center study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Sue Ann C Clemens, MD, phD, Study chair, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812586
- Sponsor's protocol ID
- OBU-01
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ann Costa Clemens S, Weckx L, Milan EP, Smolenov I, Clemens R. Interchangeability of different COVID-19 vaccine platforms as booster doses: A phase 3 study mimicking real-world practice. Vaccine. 2024 Jul 25;42(19):3989-3998. doi: 10.1016/j.vaccine.2024.05.009. Epub 2024 May 17.
PubMed 38762360
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Vaccine Boosting in a Real World Setting: Exploratory Phase 3, Cohort Randomized, Single-blind, Multi-center Study to Evaluate the Safety and Immunogenicity of a Booster Dose of Various Covid-19 Vaccines in Fully Covid-19 Vaccine-primed Subjects Regardless of the Number of Prior Booster Dose(s) Received.
- ClinicalTrials.gov ID
- NCT05812586
- Acronym / sponsor ID
- OBU-01
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 13 Apr 2023 (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.
SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it is likely that the population will have to be repeatedly boosted until a "universal" Pan-Sarbecovirus vaccine is available.
SARS-CoV-2 protein subunit vaccine candidates have shown that, despite adjuvantation, their safety/reactogenicity profile seems to be preferable over mRNA or vectored vaccines, whilst inducing non-inferior immune responses (1,2).
In this regard, serious adverse events of special interest from mRNA vaccines seem to be have been substantially underestimated/underreported. In a preliminary analysis by an International consortium, the true incidence seems to be 1,250/million excess risk in vaccinees instead of the 1-2/million reported by the Department of Health and Human Services (3,4). Additionally, in a recent study, the Clover SCB-2019 protein subunit vaccine candidate has shown higher neutralizing antibodies titers against the omicron variant, when compared to an inactivated vaccine (data not published yet). Although Brazil has various vaccine platforms authorized for emergency use or licensed, such as mRNA vaccines, vector-based vaccines, inactivated vaccines, so far Brazil has no access to adjuvanted or non-adjuvanted protein-based vaccines.
This study will involve two vaccines registered in Brazil and a protein-based adjuvanted vaccine candidate, SCB-2019/Clover. Protein-based adjuvanted vaccines have the advantage of being from a known and licensed technology that can produce high quantities of vaccine at reasonable Costs of Goods. Protein-based adjuvanted vaccines have also been shown to be highly immunogenic, both in the context of COVID-19 (2,5) and other licensed vaccines (6), with long persistence of immunity and protection.
Over 80% of the Brazilian population above the age of 18 years have received a full primary vaccination and another 7% at least one dose of vaccine. The overall booster coverage is about 48% (64% of the adults) (7). Anvisa has authorized 1st and 2nd booster doses of various vaccines in line with the MoH policy which was last updated in March 2022. It can be speculated that, like in other geographies, a third booster will be recommended soon, especially to at risk populations and in the scenario of high circulation of the Omicron BA.5 strain.
This study will explore the immunogenicity, safety and reactogenicity of a booster dose of various platforms in fully primed individuals regardless of the number of booster doses they have received prior to the enrollment in the study.
This mimics the "real world scenario" at vaccination centers where individuals with different background vaccination schemes show up for "a booster". It would facilitate logistics of immunization substantially if vaccines for boosting, independent of the immunization status, could be interchangeable with respect to safety/reactogenicity and immunogenicity. This study will enroll fully-primed individuals (2 doses of either Pfizer mRNA or Oxford/AZ/Fiocruz or Sinovac/Butantan or 1 dose of Janssen vaccine) who have received their last vaccine dose at least 4 months prior to study entry and who have received either no booster, or 1 or 2 boosters. Individuals will be stratified in cohorts by number of boosters and then randomized to receive one of 3 booster vaccines (AstraZeneca/Fiocruz, Pfizer/Wyeth, SCB-2019/Clover).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 9
- Model description
- Exploratory phase 3, cohort randomized, single-blind, multi-center study
| Arm | Type | Receives |
|---|---|---|
| Group 1: SCB-2019/Clover | Experimental | Biological: SCB-2019/CloverCohort A: complete primary immunization, no previous booster dose: SCB-2019/Clover |
| Group 2: AstraZeneca/Fiocruz | Experimental | Biological: AstraZeneca/FiocruzCohort A: complete primary immunization, no previous booster dose: AstraZeneca/Fiocruz |
| Group 3: Pfizer/Wyeth | Experimental | Biological: Pfizer/WyethCohort A: complete primary immunization, no previous booster dose: Pfizer/Wyeth |
| Group 4: SCB-2019/Clover | Experimental | Biological: SCB-2019/CloverCohort B: primary immunization plus one previous booster dose:SCB-2019/Clover |
| Group 5: AstraZeneca/Fiocruz | Experimental | Biological: AstraZeneca/FiocruzCohort B: primary immunization plus one previous booster dose: AstraZeneca/Fiocruz |
| Group 6: Pfizer/Wyeth | Experimental | Biological: Pfizer/WyethCohort B: primary immunization plus one previous booster dose: Pfizer/Wyeth |
| Group 7: SCB-2019/Clover | Experimental | Biological: SCB-2019/CloverCohort C: primary immunization plus two previous booster doses: SCB-2019/Clover |
| Group 8: AstraZeneca/Fiocruz | Experimental | Biological: AstraZeneca/FiocruzCohort C: primary immunization plus two previous booster doses: AstraZeneca/Fiocruz |
| Group 9: Pfizer/Wyeth | Experimental | Biological: Pfizer/WyethCohort C: primary immunization plus two previous booster doses: Pfizer/Wyeth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥18 years of age.
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- Individuals are willing and able to give an informed consent, prior to screening.
- Individuals must have completed vaccine priming, regardless of vaccine regimen. Primary vaccination and previous booster scheme data will be annotated as patient history.
- Interval between last dose and current study dose of a minimum of 4 months and a maximum of 24 months (to optimize candidate participation).
Key exclusion criteria (21 listed)
- 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.
- Self-reported confirmed COVID-19 infection, through RT-PCR or lateral flow test, in the last 4 weeks.
- Individuals who did not complete the primary vaccination scheme for any licensed COVID vaccine or plan to receive another COVID-19 vaccine (other than the study vaccines) 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.).
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis, venal or arterial thrombosis, thrombocytopenia) 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/Clover).
- Individuals with capillary leakage syndrome or thrombosis with thrombocytopenia syndrome
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 |
|---|---|---|
| SCB-2019/CloverSCB-2019/Clover Vaccine | Biological | Group 1: SCB-2019/Clover, Group 4: SCB-2019/Clover, Group 7: SCB-2019/Clover |
| AstraZeneca/FiocruzAstraZeneca/Fiocruz Vaccine | Biological | Group 2: AstraZeneca/Fiocruz, Group 5: AstraZeneca/Fiocruz, Group 8: AstraZeneca/Fiocruz |
| Pfizer/WyethPfizer/Wyeth Vaccine | Biological | Group 3: Pfizer/Wyeth, Group 6: Pfizer/Wyeth, Group 9: Pfizer/Wyeth |
Primary outcome
Immunogenicity
Time frame: At baseline (day 0)
Anti-Spike IgG antibody positivity and titers (ELISA) for SARS-CoV-2 strains (Wuhan and BA.5)
Immunogenicity
Time frame: At day 28 after booster dose
Anti-Spike IgG antibody positivity and titers (ELISA) for SARS-CoV-2 strains (Wuhan and BA.5)
Safety
Time frame: Throughout the study period, an average of 3 months
Occurrence of SAEs, AESIs and severe unsolicited AEs
3 secondary outcomes
Immunogenicity
Time frame: At days 0, 28 and 84
Immunogenicity
Time frame: At day 84
Safety
Time frame: Over days 0-7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 38762360Ann Costa Clemens S, Weckx L, Milan EP, Smolenov I, Clemens R. Interchangeability of different COVID-19 vaccine platforms as booster doses: A phase 3 study mimicking real-world practice. Vaccine. 2024 Jul 25;42(19):3989-3998. doi: 10.1016/j.vaccine.2024.05.009. Epub 2024 May 17.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Sue Ann C Clemens, MD, phD study chair
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCB-2019/Clover, AstraZeneca/Fiocruz and Pfizer/Wyeth in people with COVID-19, run by D'Or Institute for Research and Education at 2 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 9 inclusion and 21 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Immunogenicity (time frame: At baseline (day 0)). The study lists 3 primary outcomes in all. 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 NCT05812586, which also lists 1 linked publication.
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 13 Apr 2023.