ABDALA Clinical Study - Phase III

Phase 3

• Conditions: COVID-19; SARS-CoV2; Disease Prevention; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus

• Registration Number: RPCEC00000359
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-18
• Study Completion: 2021-07-10
• Results First Posted: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48290

Inclusion Criteria

1) Individuals aged between 19 and 80 years
2) Physical examination without significant alterations.
3) Voluntariness of the subject by signing the informed consent.

Exclusion Criteria

1) Subjects with a history of SARS-CoV-2 infection confirmed by RT-PCR or with this virological diagnosis at the time of inclusion in the study.
2) Convalescent, contact or suspect of COVID-19 at the time of inclusion.
3) Subjects who have received a vaccine candidate against COVID-19.
4) Acute infection in the last 15 days or presence, at the time of inclusion in the study, of signs and symptoms such as: fever, cough, dyspnea or anosmia / ageusia.
5) Chronic, autoimmune or endocrine-metabolic diseases decompensated at the time of inclusion.
6) Body mass index =18 or = 35 Kg / m2.
7) Subjects with tattoos in both deltoid regions.
8) Administration of any research product in the last three months.
9) Subject treated in the last three months or with any medical condition that requires an immunomodulator (interferon, transfer factor, biomodulin T, thymosin, etc.), steroid (except topical or inhaled) or cytostatic during the study.
10) Have received blood, immunoglobulins or blood products in the three months prior to the start of the study.
11) Known hypersensitivity to thiomersal and to any of the components of the formulation under study.
12) History or suspicion of alcoholism or drug dependence.
13) Pregnancy or breastfeeding. Woman of reproductive age not using contraceptives or planning pregnancy.
14) Obvious mental incapacity to issue consent and act accordingly with the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaccine efficacy (Number of symptomatic COVID-19 subjects with no evidence of previous exposure to viral infection): Those subjects with SARS-CoV-2 positive RT-PCR who present at least one major symptom or sign will pay tribute to the efficacy evaluation or at least two of the minor symptoms or signs of COVID-19. Measurement time: from 14 days after the 3rd dose of the research product.