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The purpose of this clinical trial is to compare antibody response and safety of the Covid-19 (recombinante) vaccine according to different time intervals between the first two doses (4, 8 and 12 weeks) and serologic status immediately before the vaccine.
After being informed about the study and potential risks, all participants giving written informed consent will be evaluated for eligibility criteria. At day 0, participants who meet the eligibility requirements will undergo a thorough medical evaluation and a urine pregnancy test (if applicable). Eligible participants will be placed in one of three vaccination interval groups (4, 8 or 12 weeks between the first two Covid -19 (recombinante) vaccine doses) in a randomized manner, via a computer program created by the statistical annalist. Both participant and research team will know the allocated group.
Eligible and consenting participants will have a blood sample collected (IgG Anti-S antibodies) and immediately after be administered a third dose of the Covid-19 (recombinante) vaccine. Participants will be instructed to fill out an adverse events journal for solicited adverse events for 7 days and non-solicited adverse events for 28 days after each dose. The research team will contact the participant remotely at least twice during the first two weeks.
The participant will return for a follow-up visit to the research center 28 days after each dose, to evaluate adverse events, collect blood samples (IgG Anti-S antibodies) and undergo a thorough medical evaluation.
The participant will also return to the research center to collect blood samples (IgG Anti-S antibodies) in two more follow-up visits: 6 and 12 months after vaccination with Covid-19 (recombinante).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 week interval | Experimental | Administration of two doses of the Covid-19 (recombinante) vaccine, with a 4 week interval between the two doses. |
|
| 8 week interval | Experimental | Administration of two doses of the Covid-19 (recombinante) vaccine, with a 8 week interval between the two doses. |
|
| 12 week interval | Active Comparator | Administration of two doses of the Covid-19 (recombinante) vaccine, with a 12 week interval between the two doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 (recombinante) vaccine | Biological | Administration of the Covid-19 (recombinante) vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers of IgG Anti-S antibody after two doses of Covid-19 (recombinante) | Geometric mean titers of IgG Anti-S antibodies, obtained immediately before the first dose and 28 days after the second dose of the Covid-19 (recombinante) vaccine, comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) vaccination | Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clarice Monteiro Vianna | Bio-Manguinhos/Fiocruz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Tecnologia do Paraná (TECPAR) | Curitiba | Paraná | 81.050-000 | Brazil | ||
| Hospital Universitário Pedro Ernesto/ UERJ |
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Only the laboratory technician is blind
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| Seroconversion of IgG Anti-S antibodies after two doses of Covid-19 (recombinante) by serologic status before vaccination | Seroconversion proportion, defined by an elevation of Anti-S antibody titers four times after two doses of Covid-19 (recombinante), in comparison to baseline (immediately before the first dose), comparing 4 and 8 week intervals to 12 weeks interval between the first two to doses and serologic status before vaccination | 6 months |
| Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after Covid-19 (recombinante) vaccination | Geometric mean titer of Anti-S IgG antibodies 6 and 12 months after the vaccination, according to vaccination interval group (4, 8 ans 12 weeks) and serologic status before vaccination. | 15 months |
| Reactogenicity and Safety of Covid-19 (recombinante) vaccine | Frequency, intensity and causality of solicited and non solicited adverse events up to 28 days after vaccination with Covid-19 (recombinante) vaccine. Frequency and causality of severe adverse events throughout participation in the study. | 15 months |
| Rio de Janeiro |
| 20.551-030 |
| Brazil |
| Policlinica Lincoln de Freitas Filho | Rio de Janeiro | Brazil |
| Unidade de Ensaios Clínicos em Imunobiológicos | Rio de Janeiro | Brazil |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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