Immune Response of an Interchangeable Booster Vaccine Against COVID-19 Among Individuals With Risk Factors for Severity

NCT05289206 | Unknown DMC

• 1 other identifier: CAAE: 51701821.6.0000.0005
• Study Type: interventional
• Target: 4,446
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine.

Conditions

Comorbidities and Coexisting Conditions; Healthy

Keywords

Covid19; vaccine; ChAdOx1-S/nCoV-19 [recombinant]

Outcome Measures

Primary Outcomes (1)

• Antibodies (detection and titration) against SARS-CoV-2 through quantitative test for total antibodies against viral nucleocapsid and IgG antibodies against Spike protein

  Detection and titration of antibodies against SARS-CoV-2 at baseline (Day 0) and at Day 90 and Day 180 after booster vaccination

  change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination

Secondary Outcomes (5)

• Profile of the cell-mediated immune response in a subgroup of participants through cell immunophenotyping, using the Flow Cytometry (FC) technique.

  change from baseline profile (Day 0) of the cell-mediated immune response compared to Day 90 (D90) and Day 180 (D180) after booster vaccination

• Ability of the serum from a subgroup of participants to neutralize antibodies though viral neutralization assay at baseline (Day 0) and at Day 90 and D180 after vaccine booster dose

  change from baseline (Day 0) profile of the ability to neutralize antibodies in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination

• Quantification of memory cell populations in a subgroup of participants

  change from baseline (Day 0) memory cell populations in a subgroup of participants at Day 90 (D90) and Day 180 (D180) after booster vaccination

• Physical activity and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.

  change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of physical activity

• Sedentary lifestyle and its relationship with the acquisition of antibodies against SARS-CoV-2 after booster vaccination against SARS-CoV-2.

  change from baseline (Day 0) antibodies against SARS-CoV-2 at Day 90 (D90) and Day 180 (D180) after booster vaccination and it relationship with the history of sedentary lifestyle

Study Arms (1)

Intervention - single arm

EXPERIMENTAL

Oxford/AstraZeneca (ChAdOx1-S/nCoV-19 \[recombinant\]) - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac

Other: Vaccine - ChAdOx1-S/nCoV-19 [recombinant]

Interventions

Vaccine - ChAdOx1-S/nCoV-19 [recombinant] OTHER

ChAdOx1-S/nCoV-19 \[recombinant\] - 0.5 mL single dose, intramuscular in deltoid, with an interval of 180 days (+/- 30 days) from the 2nd dose of the initial vaccination schedule with CoronaVac

Intervention - single arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have voluntarily participated and be in regular follow-up monitoring by the COVACMANAUS study;
• Have completed the vaccination schedule with 2 doses of CoronaVac, as per the COVACMANAUS study protocol for at least 180 days (+/- 30 days);
• Demonstrate availability to be followed during the follow-up period defined in the study, through visits, telephone contacts or other digital means of communication;
• Accept to participate in this new study for 6 (six) months.

You may not qualify if:

• Confirmed diagnosis of COVID-19 within the last 28 days (antigen test or RT-PCR). In this situation, vaccination can be postponed until the participant completes 30 days;
• Any other condition that, in the opinion of the Principal Investigator or its medical representative, could jeopardize the safety or rights of a potential participant or prevent them from complying with this protocol;
• Pregnancy or lactation.

Sponsors & Collaborators

• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: lead
• Fundação de Amparo à Pesquisa do Estado do Amazonas (FAPEAM): collaborator
• XP Investimentos: collaborator
• Universidade do Estado do Amazonas (UEA): collaborator
• Oswaldo Cruz Foundation: collaborator

Study Sites (1)

Fundação de Medicina Tropical Dr Heitor Vieira Dourado

Manaus, Amazonas, 69040000, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcus Lacerda, PhD

  Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental, single-arm study in participants with comorbidities, previously immunized with 2 doses of CoronaVac, who will receive a booster vaccine with 1 dose of the Oxford/AstraZeneca vaccine (ChAdOx1-S/nCoV-19 \[recombinant\]).

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: March 21, 2022
• Study Start: September 30, 2021
• Primary Completion: March 31, 2022
• Study Completion: May 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

BR (1)