Status and phase
Conditions
Treatments
About
The goals of this clinical trial are:
The main questions to be answered are:
Phase 2:
Phase 3 :
In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design.
In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female participants greater than or equal to 18 years of age
With the ability and willingness to comply with the prohibitions and restrictions specified in the protocol.
Have received a complete vaccine regimen against SARS-CoV-2 with no more than one booster dose (last dose received at least 4 months prior to study entry).
In fertile female volunteers, negative pregnancy test at the beginning of the study and commitment to use a contraceptive method from the date of signing the consent form until 3 months after vaccine study application. Use of a hormonal contraceptive method must begin at least 28 days prior to study vaccine application. The investigator should assess potential contraceptive method failure (e.g. non-compliance, recent onset) in relation to vaccination. Acceptable effective methods for this study include:
a) hormonal contraceptive method: i) combined (containing estrogen and progestin) associated with the inhibition of ovulation (oral, intravaginal or transdermal); ii) with progestin only, associated with the inhibition of ovulation (oral, injectable or implantable); b) intrauterine device; c) intrauterine hormone release system; d) bilateral tubal ligation/occlusion procedure; e) single couple with vasectomy; f) sexual abstinence, which will be considered effective only if it is defined as abstaining from heterosexual relations from the date of signing the consent until 3 months after receiving the study vaccine. The reliability of sexual abstinence should be assessed in relation to the duration of the study and the participant's usual and preferred lifestyle.
Participant who agrees to not donate bone marrow, blood or blood products until 3 months after the last dose of study vaccine;
Participant who is able to read, understand, and complete electronic questionnaires about signs and symptoms of COVID-19 surveillance;
Negative PCR or antigen test for the SARS-CoV-2 virus at enrollment time.
Capable of granting their informed consent signed and dated by the volunteer under study, and the authorized physician.
Phase-specific inclusion criteria:
Phase 2:
Phase 3:
Exclusion criteria
Exclusion Criteria:
History of SARS-CoV-2 infection or known previous disease, within 90 days prior to study entry (at least 90 days from epidemiological discharge).
Administration of any commercial or not commercial vaccine, based on:
Individuals that have not received a complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine used in the primary schedule).
Administration of complete primary vaccination schedule against SARS-CoV-2 virus (1 or 2 doses, depending on the vaccine received) or a booster dose, within 4 months prior to the start of the study.
Administration of more than one booster dose after a complete primary vaccination schedule against SARS-CoV-2 virus.
Individuals that have scheduled to receive any other commercial vaccine in the following 3 months after receiving the study vaccine dose.
Individuals that have participated in a research study within 60 days prior to the start of the study.
History of known allergies or a history of anaphylaxis or any other serious adverse reaction with other vaccines or their excipients.
History of alcoholism or substance abuse that prevents compliance with the characteristics of the protocol.
Acute infectious disease at enrollment (this does not include minor conditions such as diarrhea or mild upper respiratory tract illness) or temperature ≥38. 0°C within 24 hours prior to scheduled study vaccination; later admission is permitted at the discretion of the investigator and after the Sponsor agreement.
Body Mass Index (BMI) greater than 35 kg/m2.
History of any clinical condition that affects the function of the immune system, including, but not limited to:
The volunteer has any contraindication to receive intramuscular injections and/or blood draws.
The volunteer has received an investigational drug (including drugs related to COVID-19 prophylaxis) or used an investigational invasive medical device in the past 30 days or has received investigational immunoglobulin or monoclonal antibodies within 3 months (participation in an observational study is allowed at the discretion of the investigator, previously informing the Sponsor about this decision).
The volunteer has a history of acute polyneuropathy (e.g. Guillain Barré syndrome).
The volunteer underwent a surgical procedure that required hospitalization (defined as hospitalization for more than 24 hours or overnight hospitalization), in the 12 weeks prior to vaccination, or has not recovered completely from surgery that required hospitalization or is scheduled for surgery that will require hospitalization during the time he/she is expected to participate in the study or within 6 months of study vaccine administration.
The participant is pregnant, plans to become pregnant within 3 months after the administration of the vaccine, or is in postpartum or lactation period.
Any condition or finding regarding the participant that, in the opinion of the researcher, could put the subject under investigation at risk, or interfere with the interpretation of the results of the study.
Some events may be considered only a temporary contraindication to receiving the study vaccine. Such is the case of:
If any of these events occur at the time of vaccination, vaccination may be postponed until resolution of the event, provided that it occurs within the permitted screening period (15 days of initial testing). If the box is resolved beyond the allowed window of the selection, all initial analyses must be repeated.
Primary purpose
Allocation
Interventional model
Masking
2,014 participants in 3 patient groups
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Central trial contact
Mónica E LOMBARDO, MD
Data sourced from clinicaltrials.gov
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