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

Summary

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.

Conditions

• COVID-19

Interventions

BIOLOGICAL

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).

BIOLOGICAL

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

BIOLOGICAL

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).

BIOLOGICAL

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

BIOLOGICAL

Moderna Standard dose

Standard dose (50ug in 0.25ml)

BIOLOGICAL

Moderna Fractional dose

Fractional dose (20ug in 0.1ml)

Sponsors & Collaborators

• Universitas Padjadjaran

  collaborator OTHER

• Health Development Policy Agency, Ministry of Health Republic of Indonesia

  collaborator UNKNOWN

• Coalition for Epidemic Preparedness Innovations

  collaborator OTHER

• The Peter Doherty Institute for Infection and Immunity

  collaborator OTHER

• Indonesia University

  collaborator OTHER

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Eddy Fadlyana, Dr · Universitas Padjadjaran, Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-30

Primary Completion

2025-01-31

Completion

2025-10-31

FDA Drug

Yes

Countries

• Indonesia

Study Locations