COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04998240

Florian Marks

Not reported

2021-08-10

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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.

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.

4

International Vaccine Institute

18

65

Madagascar;Mozambique

Healthy volunteers

N/A

360

Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies;Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination;Incidence of SAEs and AESI observed at any time point during the entire study period;Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions);Incidence of unsolicited adverse events that are within 28 days after each vaccination

None

Phase 2

[{"arm_notes": "Prime BBIBP-CorV", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Prime Placebo\n", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Prime BBIBP-CorV", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Prime Placebo\n", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]