Covid-19 Living Data

Trial INA-GO0HLGB
Publication Fadlyana E, Lancet Infect Dis, 2023
Dates: 2021-11-26 to 2021-12-16
Funding: Public/non profit (Ministry of Health, Indonesia)
Conflict of interest: no COI

Methods
	RCT
	Location : Multicenter / Indonesia Follow-up duration (months): 1
	CoronaVac + boost 0.5mL ChAdOx1 (n=193) CoronaVac + boost 0.25mL ChAdOx1 (n=192) CoronaVac + boost 30 mcg BNT162b2 (n=193) CoronaVac + boost 15 mcg BNT162b2 (n=190) CoronaVac + boost 0.5mL CoronaVac (n=192)
Inclusion criteria	Clinically healthy adults aged above 18 years completed the primary series of SARS-CoV-2 vaccine with CoronaVac within 3 to <6 months or 6–9 months prior enrolment to the study or with ChAdOx1-S within 6–9 months prior enrolment to the study Signed written informed consent form and willing to commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria	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 enrollment Blood pressure ˃180/110 mmHg History of laboratory 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, dyspnea, and angioneurotic edema Those with uncontrolled autoimmune disease such as lupus History of uncontrolled coagulopathy or blood disorders, immune deficiency, and received blood derived product/transfusion within 3 months prior to enrolment Those who received immunosuppressant therapy such as corticosteroid and cancer chemotherapy Those with uncontrolled chronic disease, such as severe heart disease, asthma exacerbation Subjects who have history of uncontrolled epilepsy (within the last 2 years) or other progressive neurological disorders, such as Guillain-Barre Syndrome Those who receive any vaccination within 1 month before and after booster with study vaccine Pregnant woman with ≤13 weeks of pregnancy or pregnancy with sign of preeclampsia (swollen legs, headache, heartburn, blurred vision, blood pressure > 140/90 mmHg) Those aged ≥60 years old with difficulty in climbing 10 steps of stairs, frequently experiencing fatigue, difficulty in walking 100–200m, 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).
Interventions
	Intervention 1 IM dose of BNT162b2 (30 mcg in 0.3 mL), 6-9 months after CoronaVac primary schedule. 1 IM dose of BNT162b2 (15 mcg in 0.15 mL), 6-9 months after CoronaVac primary schedule. 1 IM dose of ChAdOx1-S (>2·5 × 108 IU in 0.5 mL), 6-9 months after CoronaVac primary schedule. 1 IM dose of ChAdOx1-S (>1·25 × 108 IU in 0.25 mL), 6-9 months after CoronaVac primary schedule.
	Control 1 IM dose of BNT162b2 Coronavac (3 mcg in 0·5 mL), 6-9 months after CoronaVac primary schedule.
Participants
	Randomized 960 participants
	Characteristics of participants Type of participants: Healthy adults N=960 533 males Children: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults without a history of laboratory confirmed COVID-19 within one month prior recruitment in 5 centres in Indonesia
Primary outcome
	In the register To evaluate the antibody titres before and one month (+7 days) after booster dose with full and half booster dose of ChAdOx1-S, Comirnaty®, or CoronaVac®.
	In the report Evaluate the seropositive, seroconversion rate and geometric mean titres of IgG anti-S-RBD and neutralising antibodies 28 days after booster dose vaccination.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, Anonymous participant data that underlie the results reported in this Article will be available on completion of the clinical trial. Data accessibility: Eddy Fadlyana: edfadlyana@yahoo.com
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the study registry, protocol and supplementary appendix were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The article reports results of booster vaccinations in participants who received a CoronaVac primary schedule; recruitment was ongoing for participants who received a ChAdOx1-S primary schedule. The primary outcome in the article reflects that in the registry. The trial (n = 960) did not achieve the target sample size in the report (n = 1000).