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
1 other identifier
interventional
360
1 country
3
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Aug 2022
Typical duration for phase_3 covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJuly 22, 2022
July 1, 2022
4 months
July 20, 2022
July 21, 2022
Conditions
Outcome Measures
Primary Outcomes (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.
28 days after the administration of a 4th dose of anti-COVID-19 vaccines
Secondary Outcomes (1)
Immunogenicity
84 days after the administration of a 4th dose of anti-COVID-19 vaccines
Other Outcomes (3)
Safety: Occurrence of SAEs, AESIs and severe unsolicited AEs
At days 28 and 84
Safety: Total and severe local / systemic solicited AEs
At days 0 to 7
Number of SARS-CoV-2 infection cases
At days 28 and 84
Study Arms (4)
Cohort A: 03 doses Pfizer/Wyeth
EXPERIMENTALGroup 1: AstraZeneca/Fiocruz Group 2: Pfizer/Wyeth Group 3: Clover SCB-2019
Cohort B: 03 doses AstraZeneca/Fiocruz
EXPERIMENTALGroup 4: AstraZeneca/Fiocruz Group 5: Pfizer/Wyeth Group 6: Clover SCB-2019
Cohort C: 03 doses Sinovac/Butantan or 02 doses and 01 dose AstraZeneca/Fiocruz
EXPERIMENTALGroup 7: AstraZeneca/Fiocruz Group 8: Pfizer/Wyeth Group 9: Clover SCB-2019
Cohort D: 02 doses AstraZeneca/Fiocruz and 01 dose Alum/CpG adjuvanted 9 or 30 µg Clover SCB-2019
EXPERIMENTALGroup 10: Clover SCB-2019
Interventions
4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
4th dose of SARS-CoV-2 vaccine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D'Or Institute for Research and Educationlead
- Bill and Melinda Gates Foundationcollaborator
- University of Oxfordcollaborator
Study Sites (3)
Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN)
Natal, Rio Grande do Norte, Brazil
Crie Unifesp
São Paulo, São Paulo, 04038-001, Brazil
Hospital Gloria D'or
Rio de Janeiro, 22211-230, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This study will be observer-blind. Due to the visual differences between the SCB-2019/Clover, Recombinant Covid-19 (AstraZeneca/Fiocruz) and mRNA Covid-19 (Comirnaty, Pfizer/Wyeth) study vaccines, the participants will be blinded before receiving the study vaccination. An unblinded dosing team, not involved with study participant's evaluation, will prepare and administer the study vaccines. The investigational product syringe will be opacified to avoid unblinding of the participant.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 22, 2022
Study Start
August 1, 2022
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
July 22, 2022
Record last verified: 2022-07