A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    960
  • sponsor
    Medigen Vaccine Biologics Corp.
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Updated on 27 April 2022
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Accepts healthy volunteers

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:

  • The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up).
  • The treatment will include 1 booster dose only.
  • The visit frequency will be 6 on-site visits and 1 phone visit.

Description

This is a Phase II, prospective, randomized, observer-blinded, multi-center study, to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with AZD1222, mRNA-1273, or MVC-COV1901 vaccine. Approximately 960 participants aged 18 ~ < 80 years, who received homologous two doses of vaccines 150 ~ 365 days ago, will be enrolled and divided into three groups. Each group will consist of 320 eligible subjects, and for each group the randomization will be stratified according to study site and age to four treatments (AZD1222, half dose of mRNA-1273, full dose or half dose of MVC-COV1901 in 1:1:1:1 ratio). Therefore, within a group, for either age stratum, there will be at least 30 participants for each treatment.

Details
Condition COVID-19 Vaccine
Treatment AZD1222, Half dose of MVC-COV1901, Full dose of MVC-COV1901, Half dose of mRNA-1273
Clinical Study IdentifierNCT05197153
SponsorMedigen Vaccine Biologics Corp.
Last Modified on27 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female participants aged ≥ 18 years at randomization
Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study
Documented to have received two homologous doses of AZD1222, mRNA-1273, or MVC-COV1901 vaccine, with the latest dose between 150 and 365 days prior to randomization, with an interval between the two homologous doses of ≥ 4 weeks to ≤ 12 weeks, and did not receive any other investigational or approved COVID-19 vaccines
Female participants must
Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal
Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the injection of study intervention. Acceptable forms include
i.Implanted hormonal methods of contraception or placement of an intrauterine device
or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch
or ring) combined with barrier methods of contraception: condom or occlusive cap
(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
c.Have a negative pregnancy test
Participant is willing and able to comply with all required study visits and follow-up
required by this protocol
Participant, and the participant's legal representative if applicable, must understand
the procedures of the study and provide written informed consent

Exclusion Criteria

Pregnant or breast feeding or have plan to become pregnant in 30 days after the
administration of study intervention
Employees at the investigator's site, of the Sponsor or delegate (e.g., contract
research organization) who are directly involved in the conduct of the study
Currently receiving or received any investigational intervention within 30 days prior
to the vaccination of study intervention
Administered any licensed live-attenuated vaccines within 28 days or other licensed
non-live-attenuated vaccines within 7 days prior to vaccination of study intervention
Administered any blood product or intravenous immunoglobulin administration within 12
weeks prior to the vaccination of study intervention
Currently receiving or anticipated to receive concomitant immunosuppressive or
immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
less than 20 mg or equivalent) within 12 weeks prior to the vaccination of study
intervention
Currently receiving or anticipated to receive treatment with tumor necrosis factor
(TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
the vaccination of study intervention
Major surgery or any radiation therapy within 12 weeks prior to the vaccination of
study intervention
Immunosuppressive illness or immunodeficient state, including hematologic malignancy
history of solid organ, bone marrow transplantation, or asplenia
A history of malignancy with potential risk for recurrence after curative treatment
or current diagnosis of or treatment for cancer (exceptions are squamous and basal
cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
discretion of the investigator)
Bleeding disorder considered a contraindication to intramuscular injection or
phlebotomy
A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia
thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, capillary
leak syndrome, myocarditis, or pericarditis
Participant with ongoing acute diseases or serious medical conditions which will
interfere with adherence to study requirements, or the evaluation of any study
endpoint
Acute diseases or serious medical conditions include cardiovascular, pulmonary
hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug
abuse, anorexia or severe depression), current severe infections, autoimmune disease
medical history, physical findings, or laboratory abnormality that in the
investigators' opinion are not in stable condition and participating in the study
could adversely affect the safety of the participant
Documented SARS-CoV1 or 2 infection prior to the study intervention
Participant with a history of hypersensitivity to any vaccine or a history of allergic
disease or reactions likely to be exacerbated by any component of the AZD1222
mRNA-1273 or MVC-COV1901
Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor
illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
of the investigator) within 2 days before the vaccination of study intervention
Any condition that is a contraindication to study intervention based on the judgement
of the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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