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COVID-19Phase 3NCT05387317

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

A Phase 3 study testing Pfizer-BioNTech Standard dose, AstraZeneca Standard dose and Pfizer-BioNTech Fractional dose in people with COVID-19, run by Murdoch Childrens Research Institute at 3 sites in Indonesia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Pfizer-BioNTech Standard dose, AstraZeneca Standard dose and Pfizer-BioNTech Fractional dose
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesIndonesia
Study dates
Apr 2024to Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

3 sites in 1 country.

Indonesia3 sites

  • Puskesmas Ciumbuleuit

    Bandung, West Java

  • Puskesmas Dago

    Bandung, West Java

  • Puskesmas Garuda

    Bandung, West Java

Other trials in Indonesia

About this study

Official title: A Randomised Controlled Trial to Assess the Immunogenicity, Safety & Reactogenicity of Standard Dose Versus Fractional Doses of COVID-19 Vaccines (Pfizer-BioNTech, AstraZeneca or Moderna) Given as a Booster Dose After Priming With Coronavac or AstraZeneca in Healthy Adults in Indonesia

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.

Read the detailed 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.

Conditions
COVID-19
Being tested
Pfizer-BioNTech Standard dose, AstraZeneca Standard dose, Pfizer-BioNTech Fractional dose, AstraZeneca Fractional dose, Moderna Standard dose
Keywords
Booster, fractional and standard doses, Pfizer, Astrazeneca, Moderna, COVID-19 vaccination, mRNA vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pfizer-BioNTech Standard doseBiological

    Also called BNT162b2, Comirnaty

    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 doseBiological

    Also called ChAdOx1-S, Vaxzevria

    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 doseBiological

    Also called BNT162b2, Comirnaty

    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 doseBiological

    Also called ChAdOx1-S, Vaxzevria

    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 doseBiological

    Also called mRNA-1273, Spikevax®

    Standard dose (50ug in 0.25ml)

  • Moderna Fractional doseBiological

    Also called mRNA-1273, Spikevax®

    Fractional dose (20ug in 0.1ml)

Study groups in NCT05387317
Study groupRoleWhat they receive
Pfizer-BioNTech Standard dose after CoronaVac primingExperimentalPfizer-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.
Receives: Biological: Pfizer-BioNTech Standard dose
Pfizer-BioNTech Fractional dose after CoronaVac primingExperimentalPfizer-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.
Receives: Biological: Pfizer-BioNTech Fractional dose
AstraZeneca Standard dose after CoronaVac primingExperimentalAstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.5ml The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Receives: Biological: AstraZeneca Standard dose
AstraZeneca Fractional dose after CoronaVac primingExperimentalAstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml The 50 participants in this arm received second CoronaVac priming dose at least 6 months prior to randomisation.
Receives: Biological: AstraZeneca Fractional dose
Moderna Standard Dose after CoronaVac primingExperimentalModerna (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.
Receives: Biological: Moderna Standard dose
Moderna Fractional Dose after CoronaVac primingExperimentalModerna (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.
Receives: Biological: Moderna Fractional dose
Pfizer-BioNTech Standard dose after AstraZeneca primingExperimentalPfizer-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.
Receives: Biological: Pfizer-BioNTech Standard dose
Pfizer-BioNTech Fractional dose after AstraZeneca primingExperimentalPfizer-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.
Receives: Biological: Pfizer-BioNTech Fractional dose
AstraZeneca Standard dose after AstraZeneca primingExperimentalAstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.5ml The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Receives: Biological: AstraZeneca Standard dose
AstraZeneca Fractional dose after AstraZeneca primingExperimentalAstraZeneca (ChAdOx1-S, Vaxzevria®). Dose: 0.25ml The 50 participants in this arm received second AstraZeneca priming dose at least 6 months prior to randomisation.
Receives: Biological: AstraZeneca Fractional dose
Moderna Standard Dose after AstraZeneca primingExperimentalModerna (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.
Receives: Biological: Moderna Standard dose
Moderna Fractional Dose afterAstraZeneca primingExperimentalModerna (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.
Receives: Biological: Moderna Fractional dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination

    Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG CMIA. The primary endpoint is the seroresponse rate at the Day-28 visit. The Seroresponse rate at the individual level is defined as either a ≥4-fold rise in binding antibodies at the Day-28 visit compared to baseline (pre-vaccination) with a titre of <200 BAU/ml, a ≥2-fold rise among participants with a baseline (pre-vaccination) titre of >≥200 BAU/ml, or ≥4 times the lower limit of detection if baseline levels are lower than the limit of detection.

    Measured: Assessed at 28 days

  2. Incidence of solicited systemic and local reactions (reactogenicity)

    Questionnaire to document solicited reactions is developed specifically for this study. Data will be reported as the proportion of participants who report grade 3 or 4 reactions by each intervention arm. Solicited reactions such as pain, tenderness, erythema/redness, induration, swelling, fever, nausea, vomiting, headache, fatigue/malaise, myalgia, arthralgia, diarrhea, enlarged lymph nodes will be collected from the participants 7 days post-vaccination.

    Measured: Assessed for 7 days post-vaccination

Secondary outcomes (11)

  1. SARS-CoV-2 specific IgG antibodies at baseline (pre booster), 6- and 12-months post booster vaccination.

    Serum samples collected at baseline (pre booster), 28 days, and 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using IgG CMIA. Data will be reported as binding antibody units (BAU)/mL and presented as geometric mean concentration (GMC) and 95% confidence intervals (CI)

    Measured: Assessed at time-points: baseline, 28 days, 6 months, and 12 months).

  2. SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination measured by surrogate virus neutralization test (sVNT)

    Serum samples collected at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific neutralising antibodies using the GenScript® cPass surrogate virus neutralization test (sVNT) for both wild-type and Omicron variant. Neutralising antibody response will be reported as percentage (%) inhibition of receptor binding domain-angiotensin-converting enzyme 2 (RBD-ACE2) binding relative to a positive control.

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  3. SARS-CoV-2 specific neutralising antibodies at baseline (pre booster), 28 days-, 6- and 12-months post booster vaccination measured by SARS-CoV-2 microneutralisation assay

    A subset of samples from all four timepoints will be assessed using a SARS-CoV-2 microneutralisation assay to both the wild type (vaccine) strain and for two SARS-CoV-2 Variants of concern. Neutralizing antibody will be reported as endpoint titre.

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  4. Interferon gamma (IFNγ) concentrations in International Units (IU)/mL

    Applicable to the subset participants with additional blood collection. Interferon gamma (IFNγ) concentrations as a measurement of cellular immunity will be assessed on a subset of the participants from each group. QuantiFERON Human IFN-γ SARS-CoV-2 (Qiagen) will be used to stimulate IFN-γ production in peripheral blood mononuclear cells (PBMCs) and then IFN-γ production will be measured using ELISA (enzyme-linked immunosorbent assay). Data will be presented as geometric mean concentration (GMC) and 95% confidence intervals (CI).

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  5. Number of IFNγ producing cells/million PBMCs

    Applicable to the subset participants with additional blood collection. IFNγ producing cells as a measurement of cellular immunity will be assessed on a subset of the participants from each group. IFN-γ Enzyme-Linked ImmunoSpot (Elispot) assay will be performed on isolated peripheral blood mononuclear cells (PBMCs). Data will be reported as number of IFNγ producing cells/million and presented using means and 95% confidence intervals.

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  6. Frequency of cytokine-expressing T cells

    Applicable to the subset participants with additional blood collection. Frequency of cytokine-expressing T cells will be assessed on a subset of participants using Flow cytometry (intracellular staining) on PBMCs samples. Data will be reported as frequency (%) of cytokine-expressing T cells presented as means and 95% CI.

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  7. Cytokine concentrations following PBMCs stimulation

    Applicable to the subset participants with additional blood collection. Cytokine concentrations following PBMCs stimulation will be assessed on a subset (40%) of participants using multiplex cytokine assays.Data will be reported as cytokine concentrations in pg/ml and presented as GMC and 95% CI.IFN-γ Elispot, intracellular cytokine assays (flow cytometry) and multiplex cytokine assays will be performed on isolated peripheral blood mononuclear cells (PBMCs)

    Measured: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).

  8. Incidence of unsolicited adverse events (AE)

    All unsolicited AE will be collected for 28 days post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE.

    Measured: 28 days post booster vaccination for all AE

  9. Incidence of medically attended adverse events

    Participants with medically attended AE will be collected for 3 months post booster vaccination. Data will be presented as proportion of participants who report unsolicited AE

    Measured: 3 months post booster vaccination for medically attended AE

  10. Incidence of serious adverse events (SAE)

    SAE will be collected throughout the follow up period of 12 months. Data will be presented as a proportion of participants who report SAE.

    Measured: 12 months post booster vaccination for SAE

  11. Incidence of confirmed COVID-19 infection

    Confirmed (Polymerase Chain Reaction [PCR] or rapid antigen test) COVID-19 infections will be documented throughout the follow-up period, by clinical severity

    Measured: Throughout the follow up period of 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study startApr 2024 (estimated)
  3. Primary completionJan 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Why it stopped: Trial cancelled prior to commencement due to lack of funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387317
Sponsor's protocol ID
RCH HREC Ref 81803
Status last verified
Mar 2024
First submitted
19 May 2022
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We will share data to ethically approved studies in cases where participants have indicated on consent form that they consent to this use of their data and where consistent with terms of collaboration agreement/s

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pfizer-BioNTech Standard dose, AstraZeneca Standard dose and Pfizer-BioNTech Fractional dose in people with COVID-19, run by Murdoch Childrens Research Institute at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination (time frame: Assessed at 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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