Efficacy and Safety of Heterologous and Homologous COVID-19 Vaccination

NCT05074368 | Completed

• 1 other identifier: 202106039MINA
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conduct a prospective analysis to compare homologous and heterologous adenovirus vector ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine inoculation. Healthy volunteers will be enrolled and divided into five groups. The first group is the subjects who received ChAdOx1- nCov-19 vaccine with 8 weeks apart; the second group is the SARS-CoV-2 messenger RNA-1273 vaccine after the first dose of ChAdOx1-nCov-19 vaccination with 8 weeks apart; the third group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 4 weeks apart; the fourth group is the SARS-CoV-2 messenger RNA-1273 vaccination with 4 weeks apart; the fifth group is the first dose of ChAdOx1-nCov-19 vaccine and the SARS-CoV-2 messenger RNA-1273 vaccine with 12 weeks apart. There will be 100 volunteers in each group. Antibody test on the day before and the 14th, 28th day and 12th week after the second dose of vaccination, including 100 subjects in each group for SARS-CoV-2 ELISA antibody titer and 50 people in each group for SARS-CoV-2 neutralizing antibody titer. Adverse reactions at the first day, the 14th day, the 28th day, and the 12th week. The research team follow up each volunteer at the 6th month.

Conditions

Healthy Adult Volunteers

Keywords

adenovirus-vector ChAdOx1 vaccination; messenger RNA (mRNA-1273 )vaccination; Coronavirus disease 2019 (COVID-19); humoral immunity; SARS-CoV-2; adverse events

Outcome Measures

Primary Outcomes (1)

• Serum Samples for by using enzyme-linkes immuno sorbent assay (ELISA) at 14th,28th,12 th week and 6 months after the second dose.

  Neutralizing antibody response among heterologous and heterologous COVID-19 vaccination and homologous

  1 years

Secondary Outcomes (3)

• Blood Sample for spike-specific CD4+ T cells

  6 months

• Blood Sample for production of interferon(IFN)-γ

  6 months

• Blood Sample for tumor necrosis factor (TNF)-α

  6 months

Other Outcomes (2)

• Adverse events

  6 months

• severe adverse events

  6 months

Study Arms (5)

Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart

ACTIVE COMPARATOR

Astra-Zeneca vaccine 0.5 mL/dose

Biological: ChAdOx1-nCov-19 (Astra-Zeneca)

mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart

ACTIVE COMPARATOR

Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose

Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine

Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart

ACTIVE COMPARATOR

Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose

Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine

The mRNA-1273 Vaccination- 4 weeks apart

ACTIVE COMPARATOR

Moderna COVID-19 Vaccine 0.5 mL/dose

Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine

Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart

ACTIVE COMPARATOR

Moderna COVID-19 Vaccine 0.5 mL/dose and Astra-Zeneca vaccine 0.5 mL/dose

Biological: ChAdOx1-nCov-19 (Astra-Zeneca); Biological: SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine

Interventions

ChAdOx1-nCov-19 (Astra-Zeneca) BIOLOGICAL

vaccine inoculation and mixed inoculation

Heterologous ChAdOx1-nCov-19 vaccination - 8 weeks apart; Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart; Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart; mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart

SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine BIOLOGICAL

vaccine inoculation and mixed inoculation

Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination- 4 weeks apart; Heterologous ChAdOx1-nCov-19 vaccination and the mRNA-1273 Vaccination-12 weeks apart; The mRNA-1273 Vaccination- 4 weeks apart; mRNA-1273 Vaccination and Heterologous ChAdOx1-nCov-19 vaccination- 8 weeks apart

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Both gender allowed
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥20 to \<65 years old and have received adenovirus vector vaccine ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 once within three months at least four weeks apart.
• The subject must sign the subject's inform consent, or the subject's legal representative must understand and agree, then sign inform consent according to procedure above.
• Healthy or existing medical condition is stable, and within 3 months before being included in the trial, he or she has not been hospitalized due to illness, and his or her condition is expected to remain stable during the trial period.

You may not qualify if:

• Are currently pregnant or breastfeeding or plan to become pregnant within 30 days after the second dose of the trial vaccine.
• Currently receiving or receiving other vaccines, including Streptococcus pneumoniae vaccine.
• Have used any blood products or intravenous immunoglobulin within 12 weeks before entering the test. Receive concurrent immunosuppressive or immunomodulatory therapy (including steroid prednisone, targeted drugs such as infliximab, adalimumab, etanercept) within 12 weeks.
• Immunosuppressive diseases or immune insufficiency states, including hematological malignancies, parenchymal organs, bone marrow transplant history or asplenia, autoimmune diseases (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, autoimmune thyroiditis, etc.) and human immunodeficiency virus infection.
• Bleeding disease and assessed as a contraindication to prohibit the use of intramuscular injection or blood draw.
• Other condition, such as physical examination or instability according to the trial investigator's judgment, or participation in this trial may adversely affect the safety of subjects, fail to comply with trial regulations, or interfere with trial evaluation indicators.
• The subject is known to have been infected with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taoyuan General Hospital, Ministry of Health and Welfare,Taoyuan,Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, X, 10002, Taiwan

Location

Related Publications (1)

• Sheng WH, Chang SY, Lin PH, Hsieh MJ, Chang HH, Cheng CY, Yang HC, Pan CF, Ieong SM, Chao TL, Chen JP, Cheng SH, Chang SC. Immune response and safety of heterologous ChAdOx1-nCoV-19/mRNA-1273 vaccination compared with homologous ChAdOx1-nCoV-19 or homologous mRNA-1273 vaccination. J Formos Med Assoc. 2022 Apr;121(4):766-777. doi: 10.1016/j.jfma.2022.02.020. Epub 2022 Mar 16.

  PMID: 35305895 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ChAdOx1 nCoV-19; Vaccines

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

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: October 12, 2021
• Study Start: July 6, 2021
• Primary Completion: April 27, 2022
• Study Completion: May 18, 2022
• Last Updated: October 18, 2022

Record last verified: 2021-10

Locations

TW (1)