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| Name | Class |
|---|---|
| Ministry of Health, Chile | OTHER_GOV |
| University of Chile | OTHER |
| Pontificia Universidad Catolica de Chile | OTHER |
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Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated vaccine booster | Experimental | One standard IM CoronaVac dose (0.5 mL) |
|
| mRNA vaccine booster | Experimental | One standard IM BNT162b2 dose (0.3 mL) |
|
| Viral vector vaccine booster | Experimental | One standard IM ChAdOx1 dose (0.5 mL) |
|
| Placebo | Placebo Comparator | Saline solution IM (0.3 mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | 0.3 mL IM saline solution |
| |
| Inactivated vaccine booster |
| Measure | Description | Time Frame |
|---|---|---|
| Early humoral response | Change in SARS-CoV-2 neutralizing antibody levels | Baseline (90-120 days after second dose of CoronaVac) and 15 days post booster dose |
| Immunogenicity | Change in SARS-CoV-2 neutralizing antibody levels | Baseline, 15, 30, 60, and 90 days post booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity | Solicited and unsolicited. Events will be assessed by scheduled visits performed by nursing home´s nurse stuff. Telephone numbers, including the PI´s cell phone will be available 24/7 for reporting any unsolicited reaction. Reporting will follow national regulations available at the Institute of Public Health web page (https://www.ispch.cl/anamed/farmacovigilancia/vacunas/como-notificar-esavi/) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ELEAMs (Nursing Homes) | Santiago | Chile | ||||
| Hospital de Urgencia Asistencia Publica |
Owing to data privacy regulations, the individual-level data in this study cannot be shared (Law N19.628).
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| Biological |
0.5 mL IM |
|
|
| mRNA vaccine booster | Biological | 0.3 mL IM |
|
|
| Viral vector vaccine booster | Drug | 0.5 mL IM |
|
|
| days 7, 28, and 3 months post booster dose |
| Safety of booster dose | Number of subjects presenting serious adverse events post booster dose. | In addition to the scheduled visits mentioned in Outcome 3, Telephone numbers, including the PI´s cell phone will be available 24/7 throughout the study (1 year) for reporting any unsolicited reaction. |
| Santiago |
| Chile |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |