Covid-19 Living Data

Trial CTRI/2022/01/039366
Publication Thuluva S, medRxiv, 2023
Dates: 2022-01-01 to 2022-08-30
Funding: Mixed (Biological E.Limited; BIRAC- a division of the Department of Biotechnology, Govt of India )
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / India Follow-up duration (months): 9
	BBV152/Boost BECOV2D = (n=156) BBV152/Boost placebo = (n=52)
Inclusion criteria	Healthy and/or high risk individuals of either gender between 18 to 80 years of age at enrolment Have received two doses of Covishield OR two doses of Covaxin, with the most recent dose at least six or nine months prior to enrolment Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration Subject agrees not to participate in another clinical trial at any time during the total study period Subject agrees to refrain from blood donation during the course of the study Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
Exclusion criteria	Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment Have previously already received one or two doses of any COVID-19 vaccine except Covishield or Covaxin Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period Hospitalized patients, patients who need intensive care and/or require a ventilator to help them breathe Subjects with body temperature of â‰¥100.4Â°F (>38.0Â°C) or symptoms of an acute illness at the time of screening or prior to vaccination Subjects with history of Covid-19 infection after receiving primary vaccination Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: a)Severe psychiatric conditions b)Any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder) c)Allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BEâ€™s CORBEVAX vaccine) Individuals who report any medical condition, or as determined by a clinician, not suitable to receive protein based subunit COVID-19 vaccines, including but not limited to allergies to the active substance or other ingredients of the vaccine Neurological illness, and any other serious chronic illness requiring hospital specialist supervision Use of medication that impairs immune system in the last 6 months, except topical or inhaled steroids or short-term oral steroids (course lasting â‰¤14 days) Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment Current or planned participation in prophylactic drug trials for the duration of the study Individuals who are part of the study team or close family members of individuals conducting the study Any medical condition that in the judgment of the investigator would make study participation unsafe.
Interventions
	Intervention 1 IM dose of BECOV2 at least 6 months after prime vaccination with BBV152
	Control 1 IM dose of Placebo at least 6 months after prime vaccination with BBV152
Participants
	Randomized 208 participants
	Characteristics of participants Type of participants: Adults N=208 0 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Adults including elderly and co-morbidities in 7 centres in India.
Primary outcome
	In the register Proportion of subjects achieving â‰¥2-fold increase in neutralizing antibodies after single booster dose of Corbevax At day 28
	In the report The primary objective of the study was to assess the immunogenicity in terms of virus neutralizing antibodies (VNA) 28 days after single booster dose of CORBEVAXâ„¢ in comparison with placebo.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: Upon request and addressed to the corresponding author Dr. Subhash Thuluva at his email subhash.thuluva@biologicale.com. IPD will not be shared (registry)
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	Low
General comment	In addition to the pre-print, the registry was used in data extraction and risk of bias assessment.The target sample size specified in the registry was achieved (n=208). Results for participants with different prime vaccination were extracted separately. The article presented interim analyses for a study with ongoing follow-up. No extractable comparative data were reported the Omicron immunogenicity outcomes, (results were reported only for the booster arm).There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes.