Clinical trial NCT05387317: Evaluation of COVID-19 Vaccines Given as a Booster in Healthy Adults in Indonesia (MIACoV Indonesia)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Keywords: Booster
fractional and standard doses
Pfizer
Astrazeneca
Moderna
COVID-19 vaccination
mRNA vaccine
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Universitas Padjadjaran
name: Health Development Policy Agency, Ministry of Health Republic of Indonesia
name: Coalition for Epidemic Preparedness Innovations
name: The Peter Doherty Institute for Infection and Immunity
name: Indonesia University
First posted: 2022-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SARS-CoV-2 specific Immunoglobulin (Ig)G antibodies at 28-days post booster vaccination
timeFrame: Assessed at 28 days
measure: Incidence of solicited systemic and local reactions (reactogenicity)
timeFrame: Assessed for 7 days post-vaccination
Secondary outcomes:
measure: SARS-CoV-2 specific IgG antibodies at baseline (pre booster), 6- and 12-months post booster vaccination.
timeFrame: Assessed at time-points: baseline, 28 days, 6 months, and 12 months).
measure: 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)
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: 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
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: Interferon gamma (IFNγ) concentrations in International Units (IU)/mL
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: Number of IFNγ producing cells/million PBMCs
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: Frequency of cytokine-expressing T cells
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: Cytokine concentrations following PBMCs stimulation
timeFrame: Assessed at 4 time-points (baseline, 28 days, 6 months, and 12 months).
measure: Incidence of unsolicited adverse events (AE)
timeFrame: 28 days post booster vaccination for all AE
measure: Incidence of medically attended adverse events
timeFrame: 3 months post booster vaccination for medically attended AE
measure: Incidence of serious adverse events (SAE)
timeFrame: 12 months post booster vaccination for SAE
measure: Incidence of confirmed COVID-19 infection
timeFrame: Throughout the follow up period of 12 months.
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Puskesmas Ciumbuleuit
state: West Java
city: Bandung
country: Indonesia
facility: Puskesmas Dago
state: West Java
city: Bandung
country: Indonesia
facility: Puskesmas Garuda
state: West Java
Study officials:
affiliation: Universitas Padjadjaran, Indonesia
name: Eddy Fadlyana, Dr
role: PRINCIPAL_INVESTIGATOR
References: