COVID-19Phase 1/2NCT05132855
The Immune Response of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine
A Phase 1/2 study testing BNT162b2, mRNA-1273 and MVC-COV1901 in people with COVID-19 and Breakthrough Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Breakthrough Infection
- What is being tested?
- BNT162b2, mRNA-1273 and MVC-COV1901
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2021to Apr 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing to give written informed consent for participation in the trial.
- Participants should receive 2 doses of the AZD1222. Evidence of this will be gathered from medical history and/or medical records including the COVID-19 vaccine registration yellow card.
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- Fever or evidence of upper respiratory tract infections
- Confirmed COVID-19 cases (PCR-confirmed infection or detectable anti-nucleocapsid protein IgG)
- History of anaphylaxis, severe allergic disease, or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine).
- Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrollment.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
Show all 10Show fewer
- Has received vaccines other than COVID-19 vaccine within one month
- Pregnancy or willingness/intention to become pregnant within 3 months post booster vaccine
- Aged < 20 years or unable to sign the informed consent
- Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data or insufficient level of language to undertake all study requirements in the opinion of the Investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Reactogenicity, and Immunogenicity of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine: a Single-blind and Randomized Study
The severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breach of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.
Read the detailed description
Safety concerns of COVID-19 ChAdOx1 nCoV-19 vaccine have led to a recommendation of heterologous boost with mRNA vaccine in several countries. Initial safety data of heterologous prime-boost with ChAdOx1 nCoV-19 and BNT162b2 vaccines showed well-tolerated. No major differences in reactogenicity were observed between homologous and heterologous vaccination. Immunogenicity of heterologous ChAdOx1 nCoV-19 and BNT162b2 vaccination is better compared with homologous ChAdOx1 nCoV-19 vaccination. Despite the scarcity of safety and immunogenicity of heterologous ChAdOx1 nCoV-19 and mRNA 1273 vaccination, the preliminary reports revealed similar findings. Although both T and B memory cells contribute to the protection, there is evidence that neutralizing serum antibody levels have high correlates of protection for symptomatic SARS-COV-2 infection. The SARS-COV-2 specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. In the real world, the ChAdOx1 nCoV-19 vaccine appeared less effective than the BNT162b2 and mRNA1273 vaccine in preventing SARS-COV-2 infection. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The S protein of the widespread SARS-COV-2 delta variant reduced the binding of neutralizing antibodies. Breakthrough infections are increasing worldwide. Vaccine effectiveness decreased significantly after the emergence of the SARS-COV-2 delta variant. Waning immunity is another potential cause of breakthrough infection. Centers for Disease Control of the United States has advocated 3rd booster dose of mRNA vaccine for people at risk of COVID-19 and those who work in high-risk settings including healthcare workers. Israel expanded its 3rd COVID-19 vaccine boost to those aged over 12 years old. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breaches of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.
With waning vaccine induced immunity and emergence of potent immune evasion SARS-CoV-2 omicron variant, previous virus and vaccine-induced immunity have failed to prevent transmission. Build-up of herd immunity through vaccination is no longer achievable so far. On the other hand, SARS- CoV-2 omicron induced immunity has been shown low cross-protective against other variants. Omicron breakthrough infection can boost existing immunity induced by vaccination. The neutralizing titer elicited by omicron breakthrough infection are much higher than that induced by 3 doses of mRNA vaccines. Hybrid immunity by vaccination and omicron breakthrough infection can elicit effective cross-neutralizing antibodies against most variants.
More than 10% of population in Taiwan have infected with omicron variant. Second booster vaccination is being advocated for health care workers. The study of dynamics of immunogenicity induced by third dose heterologous booster vaccination needs to be revised. Immunogenicity including SARS-CoV-2 anti- spike IgG, the 50% neutralizing antibody titer and IFN-secreting T cells specific to whole spike protein will be performed at 180 days after booster vaccination as schedule. Additional memory T cell epitopes and memory B cell epitopes will be studied. Some participants have been infected with the omicron variant. We will compare differences of memory T cell epitopes and memory B cell epitopes between uninfected participants and omicron breakthrough infected participants. Besides, second booster vaccination is planning to be administered in health care workers. We will compare differences of memory T cell epitopes and memory B cell epitopes between 2 boosters vaccinated participants and SARS-CoV-2 breakthrough infected participants. Immunogenicity study will be conducted 28 days after the second booster vaccination and 28 days after SARS-CoV-2 breakthrough infection. Immunogenicity study, including SARS-CoV-2 anti- spike IgG, the 50% neutralizing antibody titer (NT50) and IFN-secreting T cells specific to whole spike protein, will be compared between participants with 2 booster vaccination and SARS-CoV-2 breakthrough infection.
- Conditions
- COVID-19, Breakthrough Infection
- Being tested
- BNT162b2, mRNA-1273, MVC-COV1901
- Keywords
- COVID-19, Breakthrough infection, Heterologous vaccine booster, mRNA vaccine, Protein subunit vaccine
- Medical subject headings
- COVID-19, Breakthrough Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2Biological
BNT162b2 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA.
mRNA-1273Biological
mRNA-1273 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA.
MVC-COV1901Biological
MCV COVID-19 vaccine is a protein subunit vaccine containing S2P S-protein which passes the EUA by Taiwan FDA.
| Study group | Role | What they receive |
|---|---|---|
| Booster group 1 (BNT162b2 30ug) | Experimental | The participants in this group will receive BNT162b2 30ug as the booster dose. Receives: Biological: BNT162b2 |
| Booster group 2 (mRNA-1273 50ug) | Experimental | The participants in this group will receive mRNA-1273 50ug as the booster dose. Receives: Biological: mRNA-1273 |
| Booster group 3 (mRNA-1273 100ug) | Experimental | The participants in this group will receive mRNA-1273 100ug as the booster dose. Receives: Biological: mRNA-1273 |
| Booster group 4 (MVC-COV1901 15ug) | Experimental | The participants in this group will receive MCV COVID-19 vaccine 15ug as the booster dose. Receives: Biological: MVC-COV1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50) and IFN - secreting T cells specific to whole spike protein.
Measured: Day 28 after third dose boost
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
Measured: Day 180 after third dose boost
The immune response after heterologous boost fourth dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
Measured: Day 28 after second booster vaccination.
The immune response of breakthrough infection after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
Measured: Day 28 after breakthrough infection (after receiving third doses of any COVID-19 vaccine)
Secondary outcomes (1)
The safety of heterologous boost third dose of COVID-19 vaccines
Evaluation of the safety profile included Solicited local adverse events (AEs), solicited systemic AEs, AE of special interest (AESI), and serious adverse events (SAEs)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start30 Nov 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medigen Vaccine Biologics Corp.
- Responsible party
- Sponsor
- Investigators
- Cheng-Hsun Chiu, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132855
- Sponsor's protocol ID
- 202101767A3
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hillus D, Schwarz T, Tober-Lau P, Vanshylla K, Hastor H, Thibeault C, Jentzsch S, Helbig ET, Lippert LJ, Tscheak P, Schmidt ML, Riege J, Solarek A, von Kalle C, Dang-Heine C, Gruell H, Kopankiewicz P, Suttorp N, Drosten C, Bias H, Seybold J; EICOV/COVIM Study Group; Klein F, Kurth F, Corman VM, Sander LE. Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study. Lancet Respir Med. 2021 Nov;9(11):1255-1265. doi: 10.1016/S2213-2600(21)00357-X. Epub 2021 Aug 13.
PubMed 34391547Liu X, Shaw RH, Stuart ASV, Greenland M, Aley PK, Andrews NJ, Cameron JC, Charlton S, Clutterbuck EA, Collins AM, Dinesh T, England A, Faust SN, Ferreira DM, Finn A, Green CA, Hallis B, Heath PT, Hill H, Lambe T, Lazarus R, Libri V, Long F, Mujadidi YF, Plested EL, Provstgaard-Morys S, Ramasamy MN, Ramsay M, Read RC, Robinson H, Singh N, Turner DPJ, Turner PJ, Walker LL, White R, Nguyen-Van-Tam JS, Snape MD; Com-COV Study Group. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial. Lancet. 2021 Sep 4;398(10303):856-869. doi: 10.1016/S0140-6736(21)01694-9. Epub 2021 Aug 6.
PubMed 34370971Normark J, Vikstrom L, Gwon YD, Persson IL, Edin A, Bjorsell T, Dernstedt A, Christ W, Tevell S, Evander M, Klingstrom J, Ahlm C, Forsell M. Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination. N Engl J Med. 2021 Sep 9;385(11):1049-1051. doi: 10.1056/NEJMc2110716. Epub 2021 Jul 14. No abstract available.
PubMed 34260850Chuang CH, Huang CG, Huang CT, Chen YC, Kung YA, Chen CJ, Chuang TC, Liu CC, Huang PW, Yang SL, Gu PW, Shih SR, Chiu CH. Titers and breadth of neutralizing antibodies against SARS-CoV-2 variants after heterologous booster vaccination in health care workers primed with two doses of ChAdOx1 nCov-19: A single-blinded, randomized clinical trial. J Clin Virol. 2022 Dec;157:105328. doi: 10.1016/j.jcv.2022.105328. Epub 2022 Nov 12.
PubMed 36399969
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Reactogenicity, and Immunogenicity of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine: a Single-blind and Randomized Study
- ClinicalTrials.gov ID
- NCT05132855
- Acronym / sponsor ID
- 202101767A3
- Conditions
- COVID-19, Breakthrough Infection
- Keywords
- COVID-19, Breakthrough infection, Heterologous vaccine booster, mRNA vaccine, Protein subunit vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Medigen Vaccine Biologics Corp.
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 24 Nov 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 severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breach of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.
Detailed description
Safety concerns of COVID-19 ChAdOx1 nCoV-19 vaccine have led to a recommendation of heterologous boost with mRNA vaccine in several countries. Initial safety data of heterologous prime-boost with ChAdOx1 nCoV-19 and BNT162b2 vaccines showed well-tolerated. No major differences in reactogenicity were observed between homologous and heterologous vaccination. Immunogenicity of heterologous ChAdOx1 nCoV-19 and BNT162b2 vaccination is better compared with homologous ChAdOx1 nCoV-19 vaccination. Despite the scarcity of safety and immunogenicity of heterologous ChAdOx1 nCoV-19 and mRNA 1273 vaccination, the preliminary reports revealed similar findings. Although both T and B memory cells contribute to the protection, there is evidence that neutralizing serum antibody levels have high correlates of protection for symptomatic SARS-COV-2 infection. The SARS-COV-2 specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. In the real world, the ChAdOx1 nCoV-19 vaccine appeared less effective than the BNT162b2 and mRNA1273 vaccine in preventing SARS-COV-2 infection. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The S protein of the widespread SARS-COV-2 delta variant reduced the binding of neutralizing antibodies. Breakthrough infections are increasing worldwide. Vaccine effectiveness decreased significantly after the emergence of the SARS-COV-2 delta variant. Waning immunity is another potential cause of breakthrough infection. Centers for Disease Control of the United States has advocated 3rd booster dose of mRNA vaccine for people at risk of COVID-19 and those who work in high-risk settings including healthcare workers. Israel expanded its 3rd COVID-19 vaccine boost to those aged over 12 years old. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breaches of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.
With waning vaccine induced immunity and emergence of potent immune evasion SARS-CoV-2 omicron variant, previous virus and vaccine-induced immunity have failed to prevent transmission. Build-up of herd immunity through vaccination is no longer achievable so far. On the other hand, SARS- CoV-2 omicron induced immunity has been shown low cross-protective against other variants. Omicron breakthrough infection can boost existing immunity induced by vaccination. The neutralizing titer elicited by omicron breakthrough infection are much higher than that induced by 3 doses of mRNA vaccines. Hybrid immunity by vaccination and omicron breakthrough infection can elicit effective cross-neutralizing antibodies against most variants.
More than 10% of population in Taiwan have infected with omicron variant. Second booster vaccination is being advocated for health care workers. The study of dynamics of immunogenicity induced by third dose heterologous booster vaccination needs to be revised. Immunogenicity including SARS-CoV-2 anti- spike IgG, the 50% neutralizing antibody titer and IFN-secreting T cells specific to whole spike protein will be performed at 180 days after booster vaccination as schedule. Additional memory T cell epitopes and memory B cell epitopes will be studied. Some participants have been infected with the omicron variant. We will compare differences of memory T cell epitopes and memory B cell epitopes between uninfected participants and omicron breakthrough infected participants. Besides, second booster vaccination is planning to be administered in health care workers. We will compare differences of memory T cell epitopes and memory B cell epitopes between 2 boosters vaccinated participants and SARS-CoV-2 breakthrough infected participants. Immunogenicity study will be conducted 28 days after the second booster vaccination and 28 days after SARS-CoV-2 breakthrough infection. Immunogenicity study, including SARS-CoV-2 anti- spike IgG, the 50% neutralizing antibody titer (NT50) and IFN-secreting T cells specific to whole spike protein, will be compared between participants with 2 booster vaccination and SARS-CoV-2 breakthrough infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Booster group 1 (BNT162b2 30ug) | Experimental | Biological: BNT162b2The participants in this group will receive BNT162b2 30ug as the booster dose. |
| Booster group 2 (mRNA-1273 50ug) | Experimental | Biological: mRNA-1273The participants in this group will receive mRNA-1273 50ug as the booster dose. |
| Booster group 3 (mRNA-1273 100ug) | Experimental | Biological: mRNA-1273The participants in this group will receive mRNA-1273 100ug as the booster dose. |
| Booster group 4 (MVC-COV1901 15ug) | Experimental | Biological: MVC-COV1901The participants in this group will receive MCV COVID-19 vaccine 15ug as the booster dose. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant is willing to give written informed consent for participation in the trial.
- Participants should receive 2 doses of the AZD1222. Evidence of this will be gathered from medical history and/or medical records including the COVID-19 vaccine registration yellow card.
Key exclusion criteria (10 listed)
- Fever or evidence of upper respiratory tract infections
- Confirmed COVID-19 cases (PCR-confirmed infection or detectable anti-nucleocapsid protein IgG)
- History of anaphylaxis, severe allergic disease, or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the listed ingredients of any study vaccine).
- Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/hematological malignancy within the 6 months prior to enrollment.
- Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
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 |
|---|---|---|
| BNT162b2BNT162b2 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA. | Biological | Booster group 1 (BNT162b2 30ug) |
| mRNA-1273mRNA-1273 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA. | Biological | Booster group 2 (mRNA-1273 50ug), Booster group 3 (mRNA-1273 100ug) |
| MVC-COV1901MCV COVID-19 vaccine is a protein subunit vaccine containing S2P S-protein which passes the EUA by Taiwan FDA. | Biological | Booster group 4 (MVC-COV1901 15ug) |
Primary outcome
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Time frame: Day 28 after third dose boost
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50) and IFN - secreting T cells specific to whole spike protein.
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Time frame: Day 180 after third dose boost
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
The immune response after heterologous boost fourth dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Time frame: Day 28 after second booster vaccination.
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
The immune response of breakthrough infection after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination
Time frame: Day 28 after breakthrough infection (after receiving third doses of any COVID-19 vaccine)
Immunogenicity studies include SARS-CoV-2 anti-spike IgG, the 50% neutralizing antibody titer (NT50), IFN - secreting T cells specific to whole spike protein, and Memory T cell epitopes and memory B cell epitopes by flow cytometry.
1 secondary outcome
The safety of heterologous boost third dose of COVID-19 vaccines
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Background: PubMed 34391547Hillus D, Schwarz T, Tober-Lau P, Vanshylla K, Hastor H, Thibeault C, Jentzsch S, Helbig ET, Lippert LJ, Tscheak P, Schmidt ML, Riege J, Solarek A, von Kalle C, Dang-Heine C, Gruell H, Kopankiewicz P, Suttorp N, Drosten C, Bias H, Seybold J; EICOV/COVIM Study Group; Klein F, Kurth F, Corman VM, Sander LE. Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study. Lancet Respir Med. 2021 Nov;9(11):1255-1265. doi: 10.1016/S2213-2600(21)00357-X. Epub 2021 Aug 13.
- Background: PubMed 34370971Liu X, Shaw RH, Stuart ASV, Greenland M, Aley PK, Andrews NJ, Cameron JC, Charlton S, Clutterbuck EA, Collins AM, Dinesh T, England A, Faust SN, Ferreira DM, Finn A, Green CA, Hallis B, Heath PT, Hill H, Lambe T, Lazarus R, Libri V, Long F, Mujadidi YF, Plested EL, Provstgaard-Morys S, Ramasamy MN, Ramsay M, Read RC, Robinson H, Singh N, Turner DPJ, Turner PJ, Walker LL, White R, Nguyen-Van-Tam JS, Snape MD; Com-COV Study Group. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial. Lancet. 2021 Sep 4;398(10303):856-869. doi: 10.1016/S0140-6736(21)01694-9. Epub 2021 Aug 6.
- Background: PubMed 34260850Normark J, Vikstrom L, Gwon YD, Persson IL, Edin A, Bjorsell T, Dernstedt A, Christ W, Tevell S, Evander M, Klingstrom J, Ahlm C, Forsell M. Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination. N Engl J Med. 2021 Sep 9;385(11):1049-1051. doi: 10.1056/NEJMc2110716. Epub 2021 Jul 14. No abstract available.
- Derived from this study: PubMed 36399969Chuang CH, Huang CG, Huang CT, Chen YC, Kung YA, Chen CJ, Chuang TC, Liu CC, Huang PW, Yang SL, Gu PW, Shih SR, Chiu CH. Titers and breadth of neutralizing antibodies against SARS-CoV-2 variants after heterologous booster vaccination in health care workers primed with two doses of ChAdOx1 nCov-19: A single-blinded, randomized clinical trial. J Clin Virol. 2022 Dec;157:105328. doi: 10.1016/j.jcv.2022.105328. Epub 2022 Nov 12.
- 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.
Cheng-Hsun Chiu, MD, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNT162b2, mRNA-1273 and MVC-COV1901 in people with COVID-19 and Breakthrough Infection, run by Chang Gung Memorial 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Jul 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The immune response after heterologous boost third dose of COVID-19 vaccines after homologous prime-boost AZD1222 vaccination (time frame: Day 28 after third dose boost). 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 NCT05132855, which also lists 4 linked publications.
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 25 Jul 2022.