Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)
NCT ID: NCT05387317
Last Updated: 2024-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-04-30
2025-10-31
Brief Summary
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Both fractional and standard doses of Pfizer-BioNTech, AstraZeneca and Moderna will be tested.
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Detailed Description
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The study will be conducted at 3 clinics in Bandung. Participants will have previously received primary doses of Coronavac or Astranzeneca, with the second dose administered at least 6 months previously.
Participants will be followed for 12 months following the booster vaccine adminstration, with blood samples drawn at baseline, 28 days, 6 months and 12 months following booster vaccine administration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Pfizer-BioNTech Standard dose after CoronaVac priming
Pfizer-BioNTech (BNT162b2, or Comirnaty®) Dose: 30ug in 0.3ml
The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Pfizer-BioNTech Standard dose
Standard Dose - (30ug in 0.3ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
Pfizer-BioNTech Fractional dose after CoronaVac priming
Pfizer-BioNTech (BNT162b2, or Comirnaty®) Dose: 15ug in 0.15ml
The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Pfizer-BioNTech Fractional dose
Fractional Dose - (15ug in 0.15ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
AstraZeneca Standard dose after CoronaVac priming
AstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.5ml
The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
AstraZeneca Standard dose
Standard Dose (5xE10vp in 0.5ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
AstraZeneca Fractional dose after CoronaVac priming
AstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml
The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
AstraZeneca Fractional dose
Fractional Dose (2.5E10vp in 0.25ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
Moderna Standard Dose after CoronaVac priming
Moderna (mRNA-1273 or Spikevax®) Dose: 50ug in 0.25ml
The 100 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Moderna Standard dose
Standard dose (50ug in 0.25ml)
Moderna Fractional Dose after CoronaVac priming
Moderna (mRNA-1273 or Spikevax®) Dose: 20ug in 0.1ml
The 100 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Moderna Fractional dose
Fractional dose (20ug in 0.1ml)
Pfizer-BioNTech Standard dose after AstraZeneca priming
Pfizer-BioNTech (BNT162b2, or Comirnaty®) Dose: 30ug in 0.3ml
The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Pfizer-BioNTech Standard dose
Standard Dose - (30ug in 0.3ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
Pfizer-BioNTech Fractional dose after AstraZeneca priming
Pfizer-BioNTech (BNT162b2, or Comirnaty®) Dose: 15ug in 0.15ml
The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Pfizer-BioNTech Fractional dose
Fractional Dose - (15ug in 0.15ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
AstraZeneca Standard dose after AstraZeneca priming
AstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.5ml
The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
AstraZeneca Standard dose
Standard Dose (5xE10vp in 0.5ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
AstraZeneca Fractional dose after AstraZeneca priming
AstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml
The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
AstraZeneca Fractional dose
Fractional Dose (2.5E10vp in 0.25ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
Moderna Standard Dose after AstraZeneca priming
Moderna (mRNA-1273 or Spikevax®) Dose: 50ug in 0.25ml
The 100 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Moderna Standard dose
Standard dose (50ug in 0.25ml)
Moderna Fractional Dose afterAstraZeneca priming
Moderna (mRNA-1273 or Spikevax®) Dose: 20ug in 0.1
The 100 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Moderna Fractional dose
Fractional dose (20ug in 0.1ml)
Interventions
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Pfizer-BioNTech Standard dose
Standard Dose - (30ug in 0.3ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
AstraZeneca Standard dose
Standard Dose (5xE10vp in 0.5ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
Pfizer-BioNTech Fractional dose
Fractional Dose - (15ug in 0.15ml)
The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, encodes a P2 mutant spike protein and is formulated as an RNA-lipid nanoparticle (LNP) of nucleoside-modified mRNA (modRNA).
AstraZeneca Fractional dose
Fractional Dose (2.5E10vp in 0.25ml)
ChAdOx1 nCoV-19 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein
Moderna Standard dose
Standard dose (50ug in 0.25ml)
Moderna Fractional dose
Fractional dose (20ug in 0.1ml)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed written informed consent form and willing to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria
2. Concomitantly enrolled or scheduled to be enrolled in another trial.
3. Those with fever (temperature ˃ 37.5℃, measured with infrared thermometer/thermal gun), upper respiratory tract infection symptoms such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills and shortness of breath within 72 hours before enrolment.
4. Blood pressure ˃ 180/110 mmHg.
5. History of confirmed COVID-19 within one month prior to study enrolment.
6. History of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnoea, and angioneurotic oedema.
7. Those with uncontrolled autoimmune disease such as systemic lupus erythematosis.
8. History of uncontrolled coagulopathy or blood disorders, immune deficiency.
9. History of having received blood derived product/transfusion within 3 months prior to enrolment.
10. Those who received immunosuppressant therapy such as high-dose corticosteroid or cancer chemotherapy
11. Those with uncontrolled chronic disease, such as severe heart disease, asthma exacerbation
12. Those who have history of uncontrolled epilepsy (within the last 2 years) or other progressive neurological disorders, such as Guillain-Barre Syndrome
13. Those who have receive any vaccination within 2 weeks before study vaccine administration for this protocol, or intended to receive any vaccination within 2 weeks after study vaccine administration.
14. Pregnant woman
15. Those aged ≥60 years old with difficulty in climbing 10 steps of stairs, frequently experiencing fatigue, difficulty in walking 100-200 m, or having at least 5 comorbidities (hypertension, diabetes, cancer, chronic lung disease, heart attack, congestive heart failure, chest pain, asthma, joint pain, stroke, and kidney disease).
16. Those who are study staff working on the study or the immediate family of study investigators
18 Years
ALL
Yes
Sponsors
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Universitas Padjadjaran
OTHER
Health Development Policy Agency, Ministry of Health Republic of Indonesia
UNKNOWN
Coalition for Epidemic Preparedness Innovations
OTHER
The Peter Doherty Institute for Infection and Immunity
OTHER
Indonesia University
OTHER
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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Eddy Fadlyana, Dr
Role: PRINCIPAL_INVESTIGATOR
Universitas Padjadjaran, Indonesia
Locations
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Puskesmas Ciumbuleuit
Bandung, West Java, Indonesia
Puskesmas Dago
Bandung, West Java, Indonesia
Puskesmas Garuda
Bandung, West Java, Indonesia
Countries
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Other Identifiers
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RCH HREC Ref 81803
Identifier Type: -
Identifier Source: org_study_id
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