None listed
Conditions
Interventions
Intervention1: Monovalent vaccine: Recombinant adjuvanted COVID-19 monovalent vaccine [CoV2 PreS dTM ASO3 monovalent vaccine (D614)] will be administered as two dose series at D01 and D22 in STAGE 1 P
Sponsors
Sanofi Healthcare India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older on the day of inclusion. 2. For persons living with HIV, stable HIV infection determined by participant currently on antiretroviral with CD4 count more than 200/mm3. 3. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies. 4. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator. 5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: •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 •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 more than equal to 38.0°C [more than equal to 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 [MERS-CoV]). 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 |
|---|---|
| Efficacy: Occurrences of symptomatic COVID-19 Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placeboTimepoint: More than equals to 14 days after the second injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Efficacy: •Occurrences of SARS-CoV-2 infection •Occurrence of severe COVID-19 Key Immunogenicity: To compare the neutralizing antibody response 21 days after last vaccination (D43) to the D614G variant and B.1.351 variant between the monovalent and bivalent vaccines in SARS-CoV-2 naïve and non-naïve participants in the Random Immunogenicity Subcohort.Timepoint: More that equals to 14 days after the second injection | — |
Countries
Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico, Nigeria, Pakistan, Sri Lanka, Uganda, United States of America
Contacts
Public ContactDr Somnath Mangarule
Sanofi Healthcare India Private Limited
Outcome results
None listed