Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Booster, fractional and standard doses, Pfizer, Astrazeneca, Moderna, COVID-19 vaccination, mRNA vaccine
Eligibility Criteria
Inclusion Criteria:
- Clinically healthy adults aged 18 years and above who had completed the primary series of COVID-19 vaccine with CoronaVac or AstraZeneca more than 6 months prior to enrolment to the study.
- Signed written informed consent form and willing to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
- Those who have already received a third dose of SARS-CoV-2 vaccine
- Concomitantly enrolled or scheduled to be enrolled in another trial.
- 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.
- Blood pressure ˃ 180/110 mmHg.
- History of confirmed COVID-19 within one month prior to study enrolment.
- History of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnoea, and angioneurotic oedema.
- Those with uncontrolled autoimmune disease such as systemic lupus erythematosis.
- History of uncontrolled coagulopathy or blood disorders, immune deficiency.
- History of having received blood derived product/transfusion within 3 months prior to enrolment.
- Those who received immunosuppressant therapy such as high-dose corticosteroid or cancer chemotherapy
- Those with uncontrolled chronic disease, such as severe heart disease, asthma exacerbation
- Those who have history of uncontrolled epilepsy (within the last 2 years) or other progressive neurological disorders, such as Guillain-Barre Syndrome
- 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.
- Pregnant woman
- 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).
- Those who are study staff working on the study or the immediate family of study investigators
Sites / Locations
- Puskesmas Ciumbuleuit
- Puskesmas Dago
- Puskesmas Garuda
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Pfizer-BioNTech Standard dose after CoronaVac priming
Pfizer-BioNTech Fractional dose after CoronaVac priming
AstraZeneca Standard dose after CoronaVac priming
AstraZeneca Fractional dose after CoronaVac priming
Moderna Standard Dose after CoronaVac priming
Moderna Fractional Dose after CoronaVac priming
Pfizer-BioNTech Standard dose after AstraZeneca priming
Pfizer-BioNTech Fractional dose after AstraZeneca priming
AstraZeneca Standard dose after AstraZeneca priming
AstraZeneca Fractional dose after AstraZeneca priming
Moderna Standard Dose after AstraZeneca priming
Moderna Fractional Dose afterAstraZeneca 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 (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.
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 (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
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 (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.
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 (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.
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 (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
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 (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.