Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial
2024

Safety and Effectiveness of COVIVAC Vaccine Against COVID-19

Sample size: 374 publication 10 minutes Evidence: moderate

Author Information

Author(s): Thiem Vu Dinh, Anh Dang Duc, Ha Vu Hai, Van Thom Nguyen, Thang Tran Cong, Mateus Jose, Carreño Juan Manuel, Raghunandan Rama, Huong Nguyen Mai, Mercer Laina D., Flores Jorge, Escarrega E. Alexandar, Raskin Ariel, Thai Duong Huu, Van Be Le, Sette Alessandro, Innis Bruce L., Krammer Florian, Weiskopf Daniela

Primary Institution: National Institute of Hygiene and Epidemiology

Hypothesis

Does the COVIVAC vaccine induce a superior neutralising antibody response compared to the VAXZEVRIA vaccine?

Conclusion

The COVIVAC vaccine is safe and induces a strong immune response, potentially matching or exceeding that of the VAXZEVRIA vaccine.

Supporting Evidence

  • Participants receiving COVIVAC had higher neutralising antibody titers compared to those receiving VAXZEVRIA.
  • Both doses of COVIVAC were well tolerated with mild side effects.
  • Immunogenicity was assessed through neutralising antibody titers at multiple time points.

Takeaway

The COVIVAC vaccine helps your body fight COVID-19 and works just as well, if not better, than another vaccine called VAXZEVRIA.

Methodology

This was a phase 2, randomized, observer-blind trial comparing two doses of COVIVAC to VAXZEVRIA, with participants receiving injections 28 days apart.

Potential Biases

Potential bias due to the unblinded pharmacist and unmasked vaccinators.

Limitations

The study was limited in size and did not evaluate clinical endpoints or the vaccine's effectiveness against variants.

Participant Demographics

Participants included healthy males and non-pregnant females aged 18 and older, with a mean age of 49 years.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI 124.2–189.15 for COVIVAC 3 μg

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1016/j.vaccine.2024.126542

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