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Immunogenicity of COVID-19 Vaccine on Heterologous Schedule

NCT05054621 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-22

No results posted yet for this study

Summary

This is a prospective, single blinded randomized homologous/heterologous prime-boost vaccine clinical study, designed to assess the immunogenicity of heterologous prime-boost immunization with AZD1222 and MVC-COV1901 in adults.

Participants will be healthy adults at the age of 20-70 years who have had their first dose of COVID-19 vaccine, AZD1222. All eligible participants of 2 prime-boost interval strata (28 to 42, 56 to 70 days) will be 1:1 randomly assigned to receive a single dose of either:

* Homologous group: Intramuscular injection the same vaccine as their prime dose AZD1222
* Heterologous group: Medigen COVID-19 vaccine MVC-COV1901. The treatment phase of this study will be conducted in a single-blind fashion such that the subject will not know the identity of the subjects' study treatment assignment. After receiving the treatment, the participants will remain on study for 168 days following the boost vaccination.

For the study primary objective, immunogenicity will be assessed during the duration of the study, including serologic neutralizing antibody titer against SARS-CoV-2, serological quantification of binding antibody to SARS-CoV-2 antigen, SARS-CoV-2 antigen specific B cell and T cell frequencies and cytokine levels.

And Safety will be assessed during the duration of the study as follows:

* Solicited adverse events (AEs; local and systemic) will be assessed for 7 days following each vaccination (Day 0 through Day 7 for the boost vaccination).
* Unsolicited AEs will be recorded for 28 days following the boost vaccination.
* Serious adverse events (SAEs) will be recorded from signing of the informed consent form through Day 168.
* Adverse events of special interest (AESIs) will be recorded from the boost vaccination through Day 168.

This study is going to be conducted in a single medical center in Taiwan. An appropriate number of participants will be screened to achieve approximately 44 evaluable participants for each group. Participants in each group will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.

Conditions

  • Covid-19
  • Vaccine
  • Immunogenicity
  • Reactogenicity
  • Healthy

Interventions

BIOLOGICAL

Heterologous prime-boost schedule with AZD1222 and MVC-COV1901

Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.

BIOLOGICAL

Homologous prime-boost schedule with two doses of AZD1222

Participants will be divided into two subgroups according to the intervals, 28-42 days and 56-70 days, between the prime and booster doses.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05054621 on ClinicalTrials.gov