Immunogenicity and Safety of Heterologous and Homologous Boosting With ChAdOx1-S and CoronaVac or a Formulation of SCB-2019 (COVID-19) (TP-SCB-2019001)
Covid19
About this trial
This is an interventional prevention trial for Covid19 focused on measuring Covid19, Immunogenicity, Vaccines
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥18 years of age.
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- Individuals are willing and able to give an informed consent, prior to screening.
Individuals who:
• Received two dose of ChAdOx1-S vaccine 6 months (± 4 weeks) (Groups 1-4 of Stage 1 and Groups 5-7 of Stage 2) or CoronaVac 6 months (± 4 weeks) (Groups 8-10 of Stage 2) prior to recruitment in this study
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
Female participants are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
- Women of non-childbearing potential;
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to study vaccination. A confirmatory serum pregnancy test may be conducted at the investigator's discretion. They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the last study vaccination.
- Male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine/comparator until 6 months after the last dose of the study vaccine/comparator and also refrain from donating sperm during this period.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
- Hospital Gloria D'or
- Centro de Estudos e Pesquisa em Moléstias Infecciosas (CEPCLIN)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Stage 1 - Formulation-finding for SCB-2019 - Group 1
Stage 1 - Formulation-finding for SCB-2019 - Group 2
Stage 1 - Formulation-finding for SCB-2019 - Group 3
Stage 1 - Formulation-finding for SCB-2019 - Group 4
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 5
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 6
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 7
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 8
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 9
Stage 2 - Homologous vs. Heterologous Booster Regimen - Group 10
In Stage 1, immunogenicity and safety of three SCB-2019 formulations will be assessed in comparison with the ChAdOx1-S vaccine, in individuals who received two doses of ChAdOx1-S, 6 months (± 4 weeks) prior to recruitment. Participants (N=120) will be assigned to five groups for Stage 1 and receive doses as follows: Group 1: (N=30) Day 1: SCB-2019 (9 μg) alum;
In Stage 1, immunogenicity and safety of three SCB-2019 formulations will be assessed in comparison with the ChAdOx1-S vaccine, in individuals who received two doses of ChAdOx1-S, 6 months (± 4 weeks) prior to recruitment. Participants (N=120) will be assigned to five groups for Stage 1 and receive doses as follows: Group 2: (N=30) Day 1: SCB-2019 (9 μg) CpG 1018/alum;
In Stage 1, immunogenicity and safety of three SCB-2019 formulations will be assessed in comparison with the ChAdOx1-S vaccine, in individuals who received two doses of ChAdOx1-S, 6 months (± 4 weeks) prior to recruitment. Participants (N=120) will be assigned to five groups for Stage 1 and receive doses as follows: Group 3: (N=30) Day 1: SCB-2019 (30 μg) CpG 1018/alum;
In Stage 1, immunogenicity and safety of three SCB-2019 formulations will be assessed in comparison with the ChAdOx1-S vaccine, in individuals who received two doses of ChAdOx1-S, 6 months (± 4 weeks) prior to recruitment. Participants (N=120) will be assigned to five groups for Stage 1 and receive doses as follows: Group 4: (N=30) Day 1: ChAdOx1-S;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 5: (N=100) Day 1 (boost) -SCB-2019;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 6: (N=50) Day 1 (boost) -ChAdOx1-S;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 7: (N=50) Day 1 (boost) -CoronaVac;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 8: (N=100) Day 1 (boost) -SCB-2019;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 9: (N=50) Day 1 (boost) - ChAdOx1-S;
For Stage 2, immunogenicity of heterologous booster vaccination schedule (ChAdOx1-S (Group 5-7) - selected formulation of SCB-2019 or CoronaVac and CoronaVac (Group 8-10) - selected formulation of SCB-2019 or ChAdOx1) vs. a 2-dose ChAdOx1-S or CoronaVac series will be assessed. Participants (N=400) will be randomly (2:1:1) distributed into 6 groups for Stage 2 and receive doses as follows: Group 10: (N=50) Day 1 (boost) - CoronaVac.