Trial NCT05033847
Publication Al Kaabi N, Sig Transduct Target, 2022
Dates: 2021-09-12 to 2021-11-8
Funding: Private (Presence of employees of drug/device manufacturers among the co-authors ; The inactivated vaccine BBIBP-CorV, used as a control in this trial, was provide by Beijing Institute of Biological Products Co., Ltd.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / United Arab Emirates Follow-up duration (months): 6 | |
| 2-dose BBIBP-CorV primary schedule + NVSI-06-07 booster, 1-3 month interval (n = 301) 2-dose BBIBP-CorV primary schedule + NVSI-06-07 booster, 4-6 month interval (n = 300) 2-dose BBIBP-CorV primary schedule + NVSI-06-07 booster, 6+ month interval (n = 298) 2-dose BBIBP-CorV primary schedule + BBIBP-CorV booster, 1-3 month interval (n = 299) 2-dose BBIBP-CorV primary schedule + BBIBP-CorV booster, 4-6 month interval (n = 300) 2-dose BBIBP-CorV primary schedule + BBIBP-CorV booster, 6+ month interval (n = 302) |
|
| Inclusion criteria | Healthy adults; aged ≥18 years old; previously received a full series (two doses) of BBIBP-CorV, a COVID-19 inactivated vaccine; Female volunteers - appropriate contraceptive measures had been taken within 2 weeks before enrollment; written informed consent. |
| Exclusion criteria | History of SARS-CoV-2, SARS or MERS infection; received any COVID-19 vaccine other than BBIBP-CorV; pregnant or breastfeeding. |
| Interventions | |
| Intervention
1 IM dose 20 mcg of NVSI-06-07, 1-3 months after full schedule (2 doses) BBIBP-CorV 1 IM dose 20 mcg of NVSI-06-07, 4-6 months after full schedule (2 doses) BBIBP-CorV 1 IM dose 20 mcg of NVSI-06-07, >6 months after full schedule (2 doses) BBIBP-CorV |
|
| Control
1 IM dose 4 mcg of BBIBP-CorV, 1-3 months after full schedule (2 doses) BBIBP-CorV1 IM dose 4 mcg of BBIBP-CorV, 4-6 months after full schedule (2 doses) BBIBP-CorV1 IM dose 4 mcg of BBIBP-CorV, >6 months after full schedule (2 doses) BBIBP-CorV | |
| Participants | |
| Randomized 1800 participants | |
| Characteristics of participants Type of participants: Adults N=1800 1590 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19.2-65.4 | |
| Description of participants Healthy adults with no history of SARS-CoV-2 infection who had previously received a primary series (two doses) of BBIBP-CorV at a single center in United Arab Emirates | |
| Primary outcome | |
| In the register 1) GMT of anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 14th day after vaccination ]; 2) GMT of anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 28th day after vaccination ]; 3) 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 14th day after vaccination ]; 4) 4-fold rise of anti- SARS-CoV-2 neutralizing antibody [ Time Frame: 28th day after vaccination ] | |
| In the report The comparative assessment of immunogenicity between heterologous and homologous booster vaccinations on 14 and 28 days after the boost. | |
| Variants description | |
Variants
| |
| Description Variant prevalence not reported (Omicron, Alpha, Beta and Delta strains were used in the neutralization assay) | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, Upon trial completion |
| 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 trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article reflect those in the registry. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The trial (n = 1800) achieved its target sample size (n = 1800).
This trial was updated on June 20th, after publication of the study report. |