Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV: a phase 2 trial
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Abstract
The increased coronavirus disease 2019 (COVID-19) breakthrough cases pose the need of booster vaccination. We conducted a randomised, double-blinded, controlled, phase 2 trial to assess the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated COVID-19 vaccine (BBIBP-CorV) followed by a recombinant protein-based vaccine (NVSI-06-07), using homologous boost with BBIBP-CorV as control. Three groups of healthy adults (600 individuals per group) who had completed two-dose BBIBP-CorV vaccinations 1–3 months, 4–6 months and ≥6 months earlier, respectively, were randomly assigned in a 1:1 ratio to receive either NVSI-06-07 or BBIBP-CorV boost. Immunogenicity assays showed that in NVSI-06-07 groups, neutralizing antibody geometric mean titers (GMTs) against the prototype SARS-CoV-2 increased by 21.01–63.85 folds on day 28 after vaccination, whereas only 4.20–16.78 folds of increases were observed in control groups. For Omicron variant, the neutralizing antibody GMT elicited by homologous boost was 37.91 on day 14, however, a significantly higher neutralizing GMT of 292.53 was induced by heterologous booster. Similar results were obtained for other SARS-CoV-2 variants of concerns (VOCs), including Alpha, Beta and Delta. Both heterologous and homologous boosters have a good safety profile. Local and systemic adverse reactions were absent, mild or moderate in most participants, and the overall safety was quite similar between two booster schemes. Our findings indicated that NVSI-06-07 is safe and immunogenic as a heterologous booster in BBIBP-CorV recipients and was immunogenically superior to the homologous booster against not only SARS-CoV-2 prototype strain but also VOCs, including Omicron.
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SciScore for 10.1101/2021.12.29.21268499: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by Abu Dhabi Health Research and Technology Ethics Committee.
Consent: Written informed consent was provided for all participants prior to inclusion into the trial.Sex as a biological variable Female volunteers were not pregnant or breastfeeding, and appropriate contraceptive measures had been taken within 2 weeks before enrollment. Randomization Trial Design and Participants: This trial was designed as a phase 2, randomised, double-blinded, controlled trial conducted at a single clinical site in UAE. Blinding Participants, investigators and other staffs remained blinded to individual treatment assignment during the trial. Power Analysis Statistical… SciScore for 10.1101/2021.12.29.21268499: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by Abu Dhabi Health Research and Technology Ethics Committee.
Consent: Written informed consent was provided for all participants prior to inclusion into the trial.Sex as a biological variable Female volunteers were not pregnant or breastfeeding, and appropriate contraceptive measures had been taken within 2 weeks before enrollment. Randomization Trial Design and Participants: This trial was designed as a phase 2, randomised, double-blinded, controlled trial conducted at a single clinical site in UAE. Blinding Participants, investigators and other staffs remained blinded to individual treatment assignment during the trial. Power Analysis Statistical analysis: Assuming that a 4-fold rise in neutralizing antibody titers for both heterogeneous and homologous booster groups reached at 85% and the non-inferiority threshold was set to -10%, the sample size was determined to be 208 using Miettinen & Nurminen method to achieve 80% power at one-sided significance level of 2·5%. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:This study has limitations. First, for the volunteers enrolled in the trial, the number of men was much larger than that of women, and thus the data did not well represent the immune effects on women. Second, the proportion of older individuals aged ≥60 years in the participants was small, and the immune response was analyzed without taking into account different age ranges of the participants. Third, data on immune persistence of the booster vaccination is not yet available, and the long-term immunogenicity needs to be further studied. In summary, heterologous booster vaccination with NVSI-06-07 in BBIBP-CorV recipients was well tolerated and immunogenic against not only SARS-CoV-2 prototype strain but also the VOCs including Omicron, which supported the approval of emergency use of this heterologous booster strategy.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT05033847 Recruiting Clinical Trial on Sequential Immunization of Recombinant COV… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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