Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)

Murdoch Childrens Research Institute

Status and phase: Withdrawn; Phase 3

Conditions: COVID-19

Treatments: Biological: AstraZeneca Standard dose; Biological: Pfizer-BioNTech Standard dose; Biological: AstraZeneca Fractional dose; Biological: Moderna Fractional dose; Biological: Moderna Standard dose; Biological: Pfizer-BioNTech Fractional dose

Study type: Interventional

Funder types: Other

Identifiers

NCT05387317

RCH HREC Ref 81803

Details and patient eligibility

About

This is a randomised controlled clinical trial to determine the reactogenicity and immunogenicity of booster doses of SARS-CoV-2 vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) in adults who have previously received either AstraZeneca or Coronavac as their primary doses.

Both fractional and standard doses of Pfizer-BioNTech, AstraZeneca and Moderna will be tested.

Full description

There will be a total of 800 participants in the study, to be randomised and administered booster doses in this study.

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Signed written informed consent form and willing to comply with the instructions of the investigator and the schedule of the trial.

Exclusion criteria

1. Those who have already received a third dose of SARS-CoV-2 vaccine
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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 12 patient groups

Pfizer-BioNTech Standard dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: Pfizer-BioNTech Standard dose

Pfizer-BioNTech Fractional dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: Pfizer-BioNTech Fractional dose

AstraZeneca Standard dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: AstraZeneca Standard dose

AstraZeneca Fractional dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: AstraZeneca Fractional dose

Moderna Standard Dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: Moderna Standard dose

Moderna Fractional Dose after CoronaVac priming

Experimental group

Description:

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.

Treatment:

Biological: Moderna Fractional dose

Pfizer-BioNTech Standard dose after AstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: Pfizer-BioNTech Standard dose

Pfizer-BioNTech Fractional dose after AstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: Pfizer-BioNTech Fractional dose

AstraZeneca Standard dose after AstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: AstraZeneca Standard dose

AstraZeneca Fractional dose after AstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: AstraZeneca Fractional dose

Moderna Standard Dose after AstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: Moderna Standard dose

Moderna Fractional Dose afterAstraZeneca priming

Experimental group

Description:

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.

Treatment:

Biological: Moderna Fractional dose