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. 2022 Oct 26;10(11):1800.
doi: 10.3390/vaccines10111800.

Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial

Mohammadreza Ahi  1 , Ramin Hamidi Farahani  2 , Pouria Basiri  3 , Ahmad Karimi Rahjerdi  3   4 , Ali Sheidaei  1 , Kimiya Gohari  1 , Zahra Rahimi  1 , Fateme Gholami  1 , Milad Moradi  3 , Farzad Ghafoori Naeeni  3 , Kosar Naderi Saffar  3   4 , Soheil Ghasemi  4 , Babak Barati  4 , Sohrab Moradi  4 , Arina Monazah  4 , Fatemeh Pouranvari  4 , Mohsen Forooghizadeh  4
Affiliations

Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial

Mohammadreza Ahi et al. Vaccines (Basel). .

Abstract

Purpose: This study was completed to assess the immunogenicity and safety of the FAKHRAVAC and BBIBP-CorV vaccines as a booster dose in the population with a history of receiving two doses of BBIBP-CorV vaccine. Methods: In this double-blind, parallel clinical trial, we randomly assigned healthy adults with a history of receiving two doses of the BBIBP-CorV vaccine, who then received either the FAKHRAVAC or BBIBP-CorV vaccine as a booster dose. The trial is registered in the Iranian Registry of Clinical Trial document depository (Code: IRCT20210206050259N4). Results: The outcomes that were monitored in this study were serum neutralizing antibody (Nab) activity, immunoglobulin G (IgG) level, local and systemic adverse reactions, serious adverse events, suspected unexpected serious adverse reactions, and medically attended adverse events. After administering vaccines to 435 participants, the most frequent local and systemic adverse reactions were tenderness and nausea in 23.7% and 1.4% of cases, respectively. All adverse events were mild, occurred at a similar incidence in the two groups, and were resolved within a few days. Conclusions: On the 14th day after the booster dose injection, the seroconversion rate (i.e., four-fold increase) of Nabs for seronegative participants were 87% and 84.6% in the FAKHRAVAC® and BBIBP-CorV groups, respectively. This study shows that the FAKHRAVAC® vaccine, as a booster dose, has a similar function to the BBIBP-CorV vaccine in terms of increasing the titer of virus-neutralizing antibodies, the amount of specific antibodies, and safety.

Keywords: BBIBP-CorV; FAKHRAVAC®; clinical trial; immunogenicity; neutralizing antibody (Nab) and booster-dose injection; safety.

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Conflict of interest statement

The authors declare no conflict of interest. The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1
Figure 1
Percentage of participants with adverse reactions within 14 days of vaccines post-injection. (A,B) represent the percentage of “local” and “systemic” adverse reactions, respectively.
See this image and copyright information in PMC

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