Efficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers (COVID-BCG)
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ClinicalTrials.gov Identifier: NCT04384549 |
Recruitment Status :
Recruiting
First Posted : May 12, 2020
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection Viral, Agent as Cause of Disease Classified Elsewhere | Biological: BCG GROUP Other: PLACEBO GROUP | Phase 3 |
Randomized, multicenter phase III controlled trial, in 2 parallel arms:
- One group vaccinated with BCG
- One group receiving placebo (0.9 % saline) Randomization in a 1: 1 ratio will be stratified on the center. The study will be proposed to all heath care workers eligible. At screening, the investigator will propose the study to the participant and explain the details by providing an information letter. After signature of the consent, evaluations specific for the study will be undertaken, such as clinical examination, blood sampling, nasopharyngeal sampling in case of clinical signs.
At the inclusion visit, participants corresponding to the inclusion criteria will be randomized to receive BCG or placebo.
Participants will receive a single dose of BCG vaccine (or placebo). The adult dose of BCG vaccine (or placebo) is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the upper arm).
Follow-up visits will be done respectively at M3 and M6 and phone contacts between these two visits.
Blood samples will be collected prior to randomization (V0) and at 3 and 6 months to determine exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Where required, swab/blood samples will be taken at illness episodes to assess SARS-CoV-2 infection.
Participants will be followed for 6 months with regular mobile phone text messages 2 times weekly to collect local and general reactions until 30 days after vaccination and during the study to identify and detail COVID-19 infection.
Immunological studies will be conducted at a central Laboratory. Analysis will take place after M6 visits.
A nested study will be carried out on blood samples of 72 study subjects in order to evaluate the impact of COVID-19 on innate immunity. These blood samples will be collected at M6 among 6 groups, each containing 12 study subjects:
- One group of subjects vaccinated with BCG that have remained sero-negative for SARS CoV2
- One group of subjects having received placebo that have remained sero-negative for SARS CoV2
- One group of symptomatic subjects vaccinated with BCG
- One group of symptomatic subjects having received placebo.
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with BCG
- One group without symptoms but sero-positive for SARS CoV2 vaccinated with placebo
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Randomized Controlled Trial Evaluating the Efficacy of Vaccination With Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 Via the Strengthening of Innate Immunity in Health Care Workers |
Actual Study Start Date : | May 20, 2020 |
Estimated Primary Completion Date : | February 20, 2021 |
Estimated Study Completion Date : | February 20, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: BCG Arm
One intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units.
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Biological: BCG GROUP
One intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units.
Other Name: Experimental GROUP |
Placebo Comparator: PLACEBO Arm
One intradermal placebo injection.
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Other: PLACEBO GROUP
One intradermal injection of 0.1ml NaCl
Other Name: Control GROUP |
- Incidence of documented COVID-19 among health care workers exposed to SARS CoV2 and vaccinated with BCG compared to placebo. [ Time Frame: during the study period of 6 months ]
Documented COVID-19, i.e. symptomatic COVID-19 confirmed by either
- positive nasopharyngeal tests for SARS CoV2
- and/or by thoracic tomodensitometry compatible with the diagnosis.
- and/or SARS CoV2 seroconversion
- Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared to placebo [ Time Frame: during the study period of 6 months. ]Participants having developed a severe form of COVID-19, as defined by the necessity for hospitalization in ICU and O2 or artificial ventilation, or extracorporeal membrane oxygenation, or death
- Incidence of asymptomatic SARS CoV2 seropositive subjects among BCG-vaccinated health care workers compared to placebo. [ Time Frame: during the study period of 6 months. ]Participants with seroconversion during the study, without symptoms related to COVID-19
- Incidence of subjects with any respiratory infection among BCG-vaccinated health care workers compared to placebo. [ Time Frame: during the study period of 6 months. ]Participants presenting any kind of respiratory infection due to any cause
- Numbers of sick days and numbers of sick leaves among BCG-vaccinated health care workers compared to placebo. [ Time Frame: during the study period of 6 months ]Numbers of sick days and number of sick leaves
- Numbers of subjects with BCG-related advers events among BCG-vaccinated health care workers compared to placebo. [ Time Frame: 30 days after BCG revaccination ]Local and general events following BCG revaccination after BCG revaccination
- Numbers and intensity of changes in innate immune markers after SARS CoV2 infection among BCG-vaccinated health care workers compared to placebo. [ Time Frame: during the study period of 6 months. ]Potentially modified markers of innate immunity upon SARS CoV-2 infection to be identified

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Individual (Male and female) aged 18 or over.
- Healthcare Worker (medical or non-medical) from hospitals in direct contact with COVID-19 patients.
- Participants must give their written consent before any trial procedure.
- Participants covered by social security regimen (excepting AME).
- Healthy according to the opinion of the investigator.
Exclusion Criteria:
- Has any BCG vaccine contraindication, known allergy to the BCG vaccine or SAE to prior BCG vaccination.
- History of tuberculosis
- People with acquired or innate immunodeficiency.
- People have already been infected with SARS Cov-2 (virological documentation or TDM or seropositive if serology available).
- People who could not commit to follow-up for 6 months.
- People not in good general condition, as assessed by the investigator.
- People included in other clinical trials assessing treatment.
- Pregnant or breastfeeding or positive urine pregnancy at enrolment visit.
- BCG vaccine given within the last year.
- Another live vaccine administered in the month prior to randomization.
- History of anaphylaxis following vaccination.
- Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year. These therapies include systemic corticosteroids (more than or equal to 10 mg for more than or equal to 2 weeks), immunosuppressant, biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
- Another vaccine administered in the month prior to inclusion and randomization.
- Fever > 38°C within the past 24 hours
- People with malignancies (e.g. lymphoma, leukemia, Hodgkin's disease or other tumors of the reticuloendothelial system) or infected with HIV
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Acute severe febrile illness
- Generalized infected skin conditions
- People under legal protection measure (tutorship, curatorship or safeguard measures)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384549
Contact: Odile LAUNAY, Professor | 01 58 41 28 58 | odile.launay@aphp.fr | |
Contact: Anne RADENNE | 01 42 16 16 99 | anne.radenne@aphp.fr |
France | |
I-REIVAC/CIC 1417 Cochin Hospital, APHP | Recruiting |
Paris, France, 75014 | |
Contact: Odile LAUNAY, Professor 01 58 41 28 58 odile.launay@aphp.fr | |
Contact: Ahlam SAAD '01 58 41 33 54 ahlam.saad@aphp.fr |
Principal Investigator: | Odile LAUNAY, Professor | Assitance Publique-Hôpitaux de Paris | |
Study Director: | Camille LOCHT, Professor | Institut Pasteur de Lille |
Publications:
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT04384549 |
Other Study ID Numbers: |
APHP200462 2020-001678-31 ( EudraCT Number ) |
First Posted: | May 12, 2020 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Vaccinology Infectiology COVID-19 Health Workers |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |