Covid-19 Living Data

Trial NCT05188677
Publication Rao C, medRxiv, 2022

Funding: Private (Clover Biopharmaceuticals)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / Philippines Follow-up duration (months): 2.0
	600 SU CoronaVac (n=216) 30 mcg SCB-2019 (n=214)
Inclusion criteria	Male or female adults (≥ 18 years of age) documented history of two vaccinations with CoronaVac received at least three months previously healthy or having a stable pre-existing medical condition being willing and able to comply with all study requirements and visits, and providing informed written consent to participate.
Exclusion criteria	Any acute illness at the enrollment visit including a laboratory-confirmed SARS-CoV-2 infection initially detected by rapid antigen testing (RAT), an axillary temperature ≥ 37.5°C previous receipt of a COVID-19 vaccine other than CoronaVac (for this part of the study) any history of adverse events associated with vaccination known allergy to any vaccine component receipt of any other investigational product within 30 days of study start.
Interventions
	Intervention 1 IM dose of 30 mcg SCB-2019 at least 3 months (mean 8.82) after completion of CoronaVac primary series
	Control 1 IM dose of 600 SU CoronaVac at least 3 months (mean 8.95) after completion of CoronaVac primary series
Participants
	Randomized 430 participants
	Characteristics of participants Type of participants: Adults who are healthy or have a stable pre-existing medical condition N=430 170 males Children: 0 Mean age: Age range: 18-72
	Description of participants Adults who are healthy or have a stable pre-existing medical condition and SARS-CoV-2 infection-free in multiple centres in the Philippines.
Primary outcome
	In the register 1) GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15 [ Time Frame: Day 15 ] 2) Local and systemic solicited AEs reported within 7 days after study vaccination [ Time Frame: Up to 7 days after each vaccination ] 3) Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29 [ Time Frame: Up to Day 29 ] 4) SAEs, AEs leading to early termination from the study, MAAEs, and AESIs [ Time Frame: Through study completion, an average of 6 Months ]
	In the report 1) Demonstrate non-inferiority of a heterologous SCB-2019 boost compared with a homologous CoronaVac boost, when measured as neutralizing response against prototype Wuhan-Hu-1 SARS-CoV-2. 2) descriptive comparisons of incidence rates of solicited local reactions and systemic AEs through Day 7, unsolicited AEs up to Day 29, and SAEs and AESIs up to Day 60 in the two study groups.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, Once the study is completed the datasets, three months from initial request Data accessibility: Once the study is completed the datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants data supporting the results reported in this article, will be available three months from initial request, to researchers who provide a methodologically sound proposal, at the discretion of the company governing body. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymisation. Corresponding author: Dr. Eric Plennevaux, eric.plennevaux@cloverbiopharma.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 pre-print article, the study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The article presented preliminary 60 day analyses up to August 30, 2022 for a study with ongoing safety follow-up. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The target sample size calculated in the paper (n=424) was achieved (n=430).