COVID-19
Conditions
Interventions
Study Setting
National Institute of Infectious Diseases
The National Hospital Sri Lanka
Colombo North Teaching Hospital
This will be a Phase III, randomized, modified double-blind, placebo-controll
Sponsors
Sanofi Pasteur Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older on the day of inclusion (Both male and female) 2. For persons living with HIV, stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3 3. Subjects who have had SARS-CoV-2 rapid sero-diagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies. Both sero positive and negative subjects will be enrolled however with restriction in sero-positive numbers as a target number of sero-negative subjects need to be enrolled. 4. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator to receive the authorized vaccine available to them at the time of enrollment. 5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: o Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. OR o Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention. 6. Informed consent form has been signed and dated. 7. Able to attend all visits and to comply with all study procedures 8. Covered by health insurance, only if required by local, regional, or national regulations
Exclusion criteria
Exclusion criteria: 1. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances 2. Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator’s judgment. 3. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment. 4. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’s judgment. 5. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. 6. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ? 38.0°C [? 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. 7. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. 8. Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERSCoV]) 9. Receipt of solid-organ or bone marrow transplants in the past 180 days 10. Receipt of anti-cancer chemotherapy in the last 90 days 11. Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. 12. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 13. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrences of symptomatic COVID-19 [Time Frame: From ? 14 days after the second injection to Day 387] Presence of solicited injection site or systemic reactions (Injection site reactions: injection site pain, erythema and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills). [Time Frame: Within 7 days after vaccination ] Presence of non-serious unsolicited adverse events [ Time Frame: Within 21 days after vaccination] Presence of immediate adverse events [Time Frame: Within 30 minutes after vaccination] Presence of medically attended adverse events [Time Frame: From Day 1 to Day 387] Presence of serious adverse events [Time Frame: From Day 1 to Day 387] Presence of adverse events of special interest [Time Frame: From Day 1 to Day 387] Presence of virologically-confirmed SARS-CoV-2 infections and/or symptomatic COVID-19 [Time Frame: From Day 1 to Day 387] | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrences of SARS-CoV-2 infection. SARS-CoV-2 infection is defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection. [Time Frame: From ? 14 days after the second injection to Day 387 ] Occurrence of severe COVID-19 a. Severe COVID-19 is defined as COVID-19 with any one of the following: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes (saturation of oxygen [SpO2] = 93% on room air (corrected for altitude), PaO2/FiO2 ? 300 mm Hg, RR ? 30 breaths per minute at rest, HR ? 125 beats per minute at rest) Supplemental oxygen administration for > 1 hour Use of invasive or non-invasive ventilation or Extracorporeal Membrane Oxygenation Clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) Significant acute renal, hepatic, or neurologic dysfunction Shock (defined by systolic blood pressure ? 90 mm Hg, or diastolic blood pressure ? 60 mm Hg or requiring vasopressors) Admission to an ICU Death [Time Frame: From = 14 days after the second injection to Day 387] Occurrences of asymptomatic SARS-CoV-2 infection. Asymptomatic SARS-CoV-2 infection is defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection is ascertained. [Time Frame: From Day 1 to Day 387] Viral copies/mL in respiratory samples (Abbott RealTime SARS-CoV-2 assay will be used to quantize the viral burden in nasopharyngeal swabs and the anterior nasal swabs). [Time Frame: From Day 1 to Day 387] Number of days with positive NAAT (Nucleic Acid Amplification Test using Abbott RealTime SARS-CoV-2 assay). [Time Frame: From Day 1 to Day 387] Occurrences of positive NAAT in respiratory samples at each follow-up timepoint during symptomatic COVID-19. [Time Frame: From Day 1 to Day 387] Occurr | — |
Countries
Japan,Mexico,Pakistan,Sri Lanka,United States
Contacts
Public ContactDr. Ananda Wijewickrama
Consultant Physician
Outcome results
None listed