Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes
Randomised Phase II Study to Evaluate the Immunogenicity and Safety of Heterologous SARS-CoV-2 Vaccine Schemes (rAd26-rAd5, ChAdOx1 nCoV-19 and BBIBP-CorV).
1 other identifier
interventional
192
1 country
1
Brief Summary
To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with counterpart regimens currently in use in Argentina.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2021
CompletedAugust 20, 2021
July 1, 2021
1 month
July 8, 2021
August 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ELISA assessment of IgG anti Spike (UI/ml)
To determine whether a heterologous vaccination regimen in individuals with no known previous history of COVID-19 is non-inferior to that observed with currently used counterpart regimens. The determination of the antibody concentration in each of the study arms will be assessed by measuring the IgG antibody concentration using ELISA expressed in IU/ml.
28 days
Serious adverse events Adverse events of special interest
To report the combine and specific rate of serious adverse defined as death for any reason, any life-threatening event or any event that require inpatient hospitalization.
28 days
Secondary Outcomes (1)
Neutralising antibodies against SARS-CoV-2
28 days
Study Arms (3)
Gam-COVID-Vac / Gam-COVID-Vac
ACTIVE COMPARATORGam-COVID-Vac / ChAdOx1 nCoV-19
ACTIVE COMPARATORGam-COVID-Vac / BBIBP-CorV
ACTIVE COMPARATORInterventions
A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.
Eligibility Criteria
You may qualify if:
- Persons who have received a dose of Gam-COVID-Vac more than 30 days and less than 90 days ago.
- Age between 21 and 65 years.
- Both genders.
- Who have voluntarily agreed to participate in the clinical trial and have provided informed consent.
You may not qualify if:
- Known or suspected immunocompromised status by the study investigator for any cause.
- Use of oral or parenteral corticosteroids in the last 30 days.
- Known history of allergy to any vaccine.
- History of anaphylaxis.
- Pregnant or lactating women.
- Known history of autoimmune diseases.
- Persons under treatment for any neoplastic disease within the last 6 months.
- Any serious illness or condition at the discretion of the study investigator (including but not limited to the presence of chronic obstructive pulmonary disease, heart failure, poorly controlled hypertension, poorly controlled diabetes, renal failure).
- Planned medical procedures within two months of randomisation.
- Previous vaccination within the last 30 days with any vaccine.
- Known participation in an ongoing clinical trial.
- Ongoing acute illness.
- Fever (≥37.8 C) at the time of randomisation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ministerio de Salud de la Ciudad Autónoma de Buenos Aires
Buenos Aires, 1284, Argentina
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All personnel involved in antibody determination shall remain blinded to the assigned strategy.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 15, 2021
Study Start
July 5, 2021
Primary Completion
August 5, 2021
Study Completion
August 15, 2021
Last Updated
August 20, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share