A Phase 2, Observer-blind, Randomized Study to Assess the Safety and Immunogenicity of Heterologous Prime-boost COVID-19 Vaccines Regimens in Individuals Aged 18 to 65 Years in Mozambique and Madagascar.

IVI-ECOVA-02

This is an observer-blind, randomized study which aims to assess the immune response and the safety of two different approved vaccines for first and second dose in healthy adults.

2021-12-29

2022-09-26

2024-02-28

Active (not recruiting)

Early phase I

360

Inclusion Criteria: * Individuals aged 18 to 65 years old at the time of consent. * Residing within the area of the study and planning to stay for the study duration. * HIV negative test result on the day of screening (for those who do not have a documented HIV test results in the last three months of screening). * Female volunteers of childbearing potential with a negative pregnancy test on the day(s) of screening and vaccination, practicing/willing to practice continuous effective contraception\* recommended by the National Health System up to 12 weeks after the booster vaccination.. * Agreement to refrain from blood donation during the course of the study. * Able and willing to comply with all study requirements, based on the assessment of the investigator. * Willingness to provide written informed consent before any trial procedure \* Effective contraception is defined as follows: contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), and abstinence. Exclusion Criteria: * Pregnancy, lactation, or intention to become pregnant during the vaccination phase through three months after the booster dose. * Prior receipt/ planned receipt of any vaccine other than the study intervention within 28 days before and after each study vaccination. * Previous participation in any COVID-19 vaccination trial or vaccination campaign. * Administration of immunoglobulins and/ or any blood products within the three months preceding the administration of the study vaccine. * Known infection with hepatitis B, C virus. * Known history of allergy or anaphylaxis to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse reaction. * History of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture. * Continuous use of the anticoagulants, such as coumarins and related anticoagulants. * Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, renal disease, liver disease, endocrine disorders, and neurological illness (mild/moderate well controlled comorbidities are allowed). * Any clinically significant abnormal finding on screening as judged by the investigator. * Confirmed SARS-CoV-2 infection at enrollment. * Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within 3 months prior to recruitment (topical steroids are allowed). * Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial or result in incomplete or poor-quality data.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary analysis of this study will be a non-inferiority comparison between heterologous versus homologous boost arms 4 weeks after second vaccination within each group of the studied COVID-19 vaccines, i.e., the A1 arm (BBIBP-CorV, Ad26.COV2.S) will be compared with the A2 arm (BBIBP-CorV, BBIBP-CorV), and the B1 arm (Ad26.COV2.S, BBIBP-CorV) will be compared with the B2 arm (Placebo, Ad26.COV2.S). All 360 participants will be used for the primary analysis and the secondary analysis.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'This is an observer-blind study. So in this study only the outcome assessors should be blinded namely the clinical staff in charge of the clinical outcomes assessment and the laboratory analysts.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ACTUAL'}}

2023-04-19