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

Murdoch Childrens Research Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

COVID-19

Interventions

Pfizer-BioNTech Standard doseBIOLOGICAL

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

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

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Puskesmas Ciumbuleuit

Bandung, West Java, Indonesia

Puskesmas Dago

Bandung, West Java, Indonesia

Puskesmas Garuda

Bandung, West Java, Indonesia

Outcomes

Primary Outcomes

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.

Time frame: Assessed at 28 days

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.

Time frame: Assessed for 7 days post-vaccination

Secondary Outcomes

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)

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

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)

Data from ClinicalTrials.gov

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