COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05752201

Mónica E LOMBARDO, MD

mlombardo@cemic.edu.ar

2023-03-02

Recruiting

RCT

Randomized

Crossover

Blind label

single-center

Prevention

inclusion criteria: - all subjects who meet the following general criteria will be considered eligible for this trial: 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: 1. male or female participants between 18 and 60 years of age without known comorbidities. phase 3: 1. male or female participants greater than or equal to 18 years of age with or without any chronic comorbidity stable and controlled based on the investigator's judgment, not associated to a reduced immune response.

4

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

18

99

Argentina

Healthy volunteers

N/A

2014

Phase 2 - Immunogenicity - Seroconvertion rate;Phase 3 - Immunogenicity - Seroconvertion rate

None

Phase 2/Phase 3

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