Covid19 VaccinePhase 4NCT05079633
A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults
A Phase 4 study testing Homologous boost schedule and Heterologous boost schedule in people with Covid19 Vaccine, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and… Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19 Vaccine
- What is being tested?
- Homologous boost schedule and Heterologous boost schedule
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2021to 10 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participant aged ≥20 to <70 years at randomization.
- Has received one dose of the mRNA-1273 8 to 12 weeks before randomization.
- Female participant 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 last administration of study intervention. Acceptable forms include:
- 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 or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Who cannot join
- Pregnant or breast feeding or have plan to become pregnant within 30 days after the administration of study intervention.
- Currently receiving or received any investigational intervention within 30 days prior to the study intervention.
- Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the study intervention.
- Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the study intervention.
- Currently receiving or anticipate 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 study intervention.
- Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the study intervention.
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- Major surgery or any radiation therapy within 12 weeks prior to the study intervention.
- Has received any investigational or licensed COVID-19 vaccine other than mRNA-1273, or ≥ two doses of mRNA-1273.
- 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 IM injection or phlebotomy.
- Known SARS-CoV-2 infection in the recent 3 months prior to the study intervention.
- A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
- A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the 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 study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Group, Prospective, Randomized, Double-blind, Two-arm, Single-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of mRNA-1273 in Heterologous Prime-Boost With MVC-COV1901 in Adult Volunteers of 20 to 70 Years
The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin, the immunogenicity against the VoCs, the antigen specific cellular immune response, as well as the potential efficacy of study intervention in preventing COVID-19.
Read the detailed description
This is a parallel group, prospective, randomized, double-blind, two-arm, single-center study to be conducted in approximately 220 healthy participants aged 20 to 70 years who are generally healthy or with stable pre-existing health condition.
The participants should previously have their first dose of mRNA-1273. The participants, investigators, and the site personnel will be blinded to the study intervention assignment until all the participants complete their Day 29. Preparation and administration of study intervention will be performed by authorized unblinded site personnel who do not participate in the evaluation of the participants.
Eligible participants will be randomized to receive either mRNA-1273 or MVC-COV1901 vaccine at a 1:1 ratio. Randomization of participants will be stratified by the interval apart from their first dose of mRNA-1273 (< 10 weeks or ≥ 10 weeks).
The study consists of 6 on-site visits:
Day -28 to Day 1, Visit 1 (Screening) Day 1, Visit 2 (study intervention) Day 15 ± 3 days, Visit 3 Day 29 ± 3 days, Visit 4 Day 91 ± 14 days, Visit 5 Day 181 ± 14 days, Visit 6 Unscheduled visit(s) may be arranged when deemed necessary by the investigator.
- Conditions
- Covid19 Vaccine
- Being tested
- Homologous boost schedule, Heterologous boost schedule
- Keywords
- Covid19 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homologous boost scheduleBiological
1st dose mRNA 1273 , 2nd dose mRNA 1273
Heterologous boost scheduleBiological
1st dose mRNA 1273 , 2nd dose MVC COV1901
| Study group | Role | What they receive |
|---|---|---|
| Moderna COVID-19 vaccine (mRNA 1273) | Active comparator | 110 participants will be randomly assigned to Moderna COVID 19 Receives: Biological: Homologous boost schedule |
| Medigen COVID-19 vaccine (MVC COV1901) | Experimental | 110 participants will be randomly assigned to Medigen COVID 19 vaccine Receives: Biological: Heterologous boost schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Immunogenicity-GMT
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention
-Geometric mean titer (GMT)
Measured: Day 1 to Day 15
Primary Immunogenicity-SCR
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention
-Seroconversion rate (SCR)
Measured: Day 1 to Day 15
Primary Immunogenicity-GMR
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention
-GMT ratio
Measured: Day 1 to Day 15
Primary Safety
To evaluate the safety and tolerability of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273) from Day 1 to Day 29
The number and percentage of participants with the occurrence of:
- Solicited local adverse events (AEs)
- Solicited systemic AEs
- Unsolicited AEs
Measured: Day 1 to Day 29
Secondary outcomes (4)
Secondary Immunogenicity-GMT
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention
-Geometric mean titer (GMT)
Measured: Day 29 to Day 181
Secondary Immunogenicity-SCR
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention
-Seroconversion rate (SCR)
Measured: Day 29 to Day 181
Secondary Immunogenicity-GMR
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention
-GMT ratio
Measured: Day 29 to Day 181
Secondary Safety
To evaluate the safety of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) throughout the study
The number and percentage of participants with the occurrence of:
- Medically Attended Adverse Events (MAAEs)
- Adverse Event of Special Interest (AESIs)
- Vaccine-Associated Enhanced Disease (VAED)
- Serious Adverse Events(SAEs)
Measured: Day 1 to Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start30 Sep 2021
- Primary completion8 Oct 2021
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19 VaccineStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Min Hsieh, MD.Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079633
- Sponsor's protocol ID
- 202108058MINB
- Status last verified
- Jan 2023
- First submitted
- 23 Sep 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang ST, Huang YS, Liu WD, Pan SC, Sun HY, Lien CE, Chen C, Hsieh SM. Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. J Formos Med Assoc. 2023 Nov;122(11):1165-1173. doi: 10.1016/j.jfma.2023.05.030. Epub 2023 Jun 14.
PubMed 37321955
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group, Prospective, Randomized, Double-blind, Two-arm, Single-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of mRNA-1273 in Heterologous Prime-Boost With MVC-COV1901 in Adult Volunteers of 20 to 70 Years
- ClinicalTrials.gov ID
- NCT05079633
- Acronym / sponsor ID
- 202108058MINB
- Conditions
- Covid19 Vaccine
- Keywords
- Covid19 vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin, the immunogenicity against the VoCs, the antigen specific cellular immune response, as well as the potential efficacy of study intervention in preventing COVID-19.
Detailed description
This is a parallel group, prospective, randomized, double-blind, two-arm, single-center study to be conducted in approximately 220 healthy participants aged 20 to 70 years who are generally healthy or with stable pre-existing health condition.
The participants should previously have their first dose of mRNA-1273. The participants, investigators, and the site personnel will be blinded to the study intervention assignment until all the participants complete their Day 29. Preparation and administration of study intervention will be performed by authorized unblinded site personnel who do not participate in the evaluation of the participants.
Eligible participants will be randomized to receive either mRNA-1273 or MVC-COV1901 vaccine at a 1:1 ratio. Randomization of participants will be stratified by the interval apart from their first dose of mRNA-1273 (< 10 weeks or ≥ 10 weeks).
The study consists of 6 on-site visits:
Day -28 to Day 1, Visit 1 (Screening) Day 1, Visit 2 (study intervention) Day 15 ± 3 days, Visit 3 Day 29 ± 3 days, Visit 4 Day 91 ± 14 days, Visit 5 Day 181 ± 14 days, Visit 6 Unscheduled visit(s) may be arranged when deemed necessary by the investigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderna COVID-19 vaccine (mRNA 1273) | Active comparator | Biological: Homologous boost schedule110 participants will be randomly assigned to Moderna COVID 19 |
| Medigen COVID-19 vaccine (MVC COV1901) | Experimental | Biological: Heterologous boost schedule110 participants will be randomly assigned to Medigen COVID 19 vaccine |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participant aged ≥20 to <70 years at randomization.
- Has received one dose of the mRNA-1273 8 to 12 weeks before randomization.
- Female participant must:
- Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
- Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Key exclusion criteria (16 listed)
- Pregnant or breast feeding or have plan to become pregnant within 30 days after the administration of study intervention.
- Currently receiving or received any investigational intervention within 30 days prior to the study intervention.
- Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the study intervention.
- Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the study intervention.
- Currently receiving or anticipate 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 study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homologous boost schedule1st dose mRNA 1273 , 2nd dose mRNA 1273 | Biological | Moderna COVID-19 vaccine (mRNA 1273) |
| Heterologous boost schedule1st dose mRNA 1273 , 2nd dose MVC COV1901 | Biological | Medigen COVID-19 vaccine (MVC COV1901) |
Primary outcome
Primary Immunogenicity-GMT
Time frame: Day 1 to Day 15
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Geometric mean titer (GMT)
Primary Immunogenicity-SCR
Time frame: Day 1 to Day 15
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Seroconversion rate (SCR)
Primary Immunogenicity-GMR
Time frame: Day 1 to Day 15
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -GMT ratio
Primary Safety
Time frame: Day 1 to Day 29
To evaluate the safety and tolerability of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273) from Day 1 to Day 29 The number and percentage of participants with the occurrence of: * Solicited local adverse events (AEs) * Solicited systemic AEs * Unsolicited AEs
4 secondary outcomes
Secondary Immunogenicity-GMT
Time frame: Day 29 to Day 181
Secondary Immunogenicity-SCR
Time frame: Day 29 to Day 181
Secondary Immunogenicity-GMR
Time frame: Day 29 to Day 181
Secondary Safety
Time frame: Day 1 to Day 181
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 37321955Huang ST, Huang YS, Liu WD, Pan SC, Sun HY, Lien CE, Chen C, Hsieh SM. Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. J Formos Med Assoc. 2023 Nov;122(11):1165-1173. doi: 10.1016/j.jfma.2023.05.030. Epub 2023 Jun 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Min Hsieh, MD.Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Homologous boost schedule and Heterologous boost schedule in people with Covid19 Vaccine, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Immunogenicity-GMT (time frame: Day 1 to Day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.