ClinicalTrials.Veeva

Menu

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

M

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Withdrawn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

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

Trial contacts and locations

3

Loading...

Central trial contact

Emma Watts; Kim Mulholland, MD/Prof

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems