Status:
COMPLETED
Phase IIB Study of Recombinant Novel Coronavirus Vaccine
Lead Sponsor:
Fundación Huésped
Collaborating Sponsors:
Dalhousie University
CanSino Biologics Inc.
Conditions:
COVID-19 Vaccine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label and non-randomized study to demonstrate the immunogenicity and safety profile in adults that received the Ad5-nCoV vaccine at least 21 days but no later than 90 days after the fi...
Detailed Description
There are 4 planned site visits in total: V1 (day0), V2 (day21), V3 (month 3), V4 (month 6) Healthy adults aged 18 years and above in Argentina will be informed by a procedure approved by the ethical ...
Eligibility Criteria
Inclusion
- Participants aged 18 years and above at the time of randomization.
- Provide written informed consent.
- Axillary temperature ≤ 37℃.
- Never received any investigational or licensed COVID-19 vaccine other than the 1st dose of Sputnik V with an interval of 21-90 days before the study.
- Subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.
Exclusion
- Have a history of seizures, epilepsy, encephalopathy, psychosis.
- History of anaphylaxis to any vaccine component.
- Positive urine pregnancy test result, pregnant, lactation women, or intend to become pregnant within the next 6 months.
- Congenital or acquired angioedema/neuroedema.
- Medical history of Guillain-Barré syndrome.
- Asplenia or functional absence of spleen.
- Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months,
- History of chronic systematic infection.
- Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
- Receiving anti-tuberculosis or cancer treatment.
- History of laboratory-confirmed COVID-19, or has a positive result at the examination of SARS-CoV-2 antigen before vaccination.
- Planned to receive any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination.
- Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban).
- Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05293223
Start Date
October 1 2021
End Date
December 15 2023
Last Update
June 25 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1202
2
Centro de vacunación PREVIVAX
Ciudad Autonoma de Buenos Aire, Ciudad Autónoam de Buenos Aires, Argentina, 1414
3
Centro de Investigación y Prevención Cardiovascular CIPREC
Buenos Aires, Argentina, 1119