Trial NCT 05175625; IRCT20150303021315N26
Publication Tabarsi P, Immunology, 2022
Funding: Private (CinnaGen )
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Iran Follow-up duration (months): 0.5 | |
Booster (after 2 prime doses of either Inactivated whole virus/Viral vector/SpikoGen): 25 mcg SpikoGen (n = 250) Placebo (n = 50) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
1 IM dose of SpikoVax 25 mcg, 4-9 months after primary series. |
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Control
1 IM dose of placebo, 4-9 months after primary series. | |
Participants | |
Randomized 300 participants | |
Characteristics of participants Type of participants: Adults N=300 132 males Children: 0 Pregnant women: 0 Mean age: Age range: NR | |
Description of participants Adults including elderly and stable co-morbidities in a single centre in Iran. | |
Primary outcome | |
In the register Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies [ Time Frame: 14 days after the booster dose ] As measured by ELISA | |
In the report Seroconversion rate of neutralizing antibodies via surrogate virus-neutralizing test (sVNTw) on Day 14 | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
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 published article, the trial registries and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. Unsolicited adverse events were pre-specified in the registry but not reported in the publication. There is no change from the trial registration in the intervention and control treatments. Preliminary analysis of serious adverse events, which are still being followed up until 6 months after booster. The trial (n = 300) its target sample size (n = 300). |