The purpose of this study is to evaluate the antibody response, safety and reactogenicity of a third dose Covid-19 (recombinante) vaccine, 6 months after a two-dose vaccine schedule using the same vaccine in all doses.
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). Previous vaccination information will be collected with the participant and checked via digital Covid-19 vaccine certification from the Brazilian public health national immunization program system (SI-PNI) ou from Fundação Oswaldo Cruz (Fiocruz) institutional occupational medicine data. According to the data collected, participants will be placed in one of two groups: 8 or 12 weeks interval between the first two vaccine doses in the vaccine schedule. Eligible and consenting participants will have a blood sample collected and receive immediately after 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 the third dose. The research team will contact the participant remotely at least once during the first two weeks. The participant will return for a follow-up visit to the research center 28 days after the third dose, to evaluate adverse events, collect a second blood sample and undergo a thorough medical evaluation. The participant will return to the research center to collect blood samples in three more follow-up visits: 3 months, 6 months and 12 months after the third dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
662
Third dose of the Covid-19 (recombinante) vaccine, 6 months after the second dose of a two dose Covid-19 (recombinante) homologous vaccine schedule.
Unidade de Ensaios Clínicos em Imunobiológicos
Rio de Janeiro, Brazil
RECRUITINGIgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses.
Time frame: 28 days
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine.
Time frame: 15 months
Safety and reactogenicity of a third dose of Covid-19 (recombinate) vaccine
Safety and reactogenicity after a third dose of Covid-19 (recombinate) vaccine, 7 days for solicited adverse events, 28 days for non-solicited adverse events and 12 months for serious adverse events.
Time frame: 15 months
Neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample
Measure neutralizing antibodies in plaque reduction neutralization test (PRNT) in a smaller sample of participants, immediately before and 28 days after the third dose.
Time frame: 28 days
IgG Anti-S response after a third dose of Covid-19 (recombinante) vaccine by age groups
Equivalence of antibody IgG Anti-S response in geometric mean titers, measured immediately before and 28 days after a third dose of Covid-19 (recombinante) vaccine, administered 6 months after the second dose of a two-dose homologous Covid-19 (recombinante) vaccine schedule, between participants with an 8 and 12 week interval between the first two doses. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
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Time frame: 1 month
Duration of Immunogenicity after the third dose of Covid-19 (recombinate) vaccine after 3, 6 and 12 months by age groups
Antibody IgG Anti-S collected immediately before, 28 days, 3 months, 6 months and 12 months after the third dose of Covid-19 (recombinante) vaccine. Compare results between participants with 40 years or less, 40 to 60 years, or more than 60 years.
Time frame: 15 months