In a recent study published on the medRxiv * prepress server, the researchers compared the immunogenicity and safety of the protein-based heterodimer vaccine (PHH-1V) and the 2019 BNT162b2 coronavirus disease vaccines (COVID-19).
Study: Safety and immunogenicity of protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicenter, randomized, double-blind, non-inferiority phase IIb trial . Image credit: davide bonaldo / Shutterstock
Fund
A coronavirus 2 (SARS-CoV-2) vaccine of severe acute respiratory syndrome called PHH-1V has been shown to be well tolerated and safe among young and healthy adults. More research is needed to understand the efficacy of PHH-1V against COVID-19.
About the study
In the present study, the researchers reported the immunogenicity and safety of a heterologous COVID-19 PHH-1V booster compared to a homologous booster BNT162b2 at 14 and 98 days after COVID-19 vaccination.
This phase IIb non-inferiority, double-blind trial evaluated the safety and immunogenicity of PHH-1V and was performed in 10 centers located in Spain. People eligible for the study were 18 years of age or older and had a history of two doses of the BNV162b2 COVID-19 vaccine between 182 and 365 days after the second dose of the vaccine. Eligible participants also had a body mass index (BMI) of 18 to 40 kg / m2, were negative for the polymerase chain reaction (PCR) for SARS-CoV-2 at the time of enrollment in the ‘study and were willing to avoid vaccinations with other vaccines four weeks before or after vaccination against COVID-19.
The team randomly assigned participants in a 2: 1 ratio to administer a third dose of vaccine with the BNT162b2 vaccine or the PHH-1V vaccine. Participants were also assigned for treatment with interactive response technology (IRT). The team categorized the allocation sequence according to the age group of the participants, with 90% of the subjects in the cohort aged 18 to 64 years and 10% in the cohort aged 65 and over.
Study visits were established on days zero, 14, 28, and at three, six, and 12 months for eligible vaccinated participants on the day zero visit. Participants were vaccinated with BNT162b2 and PHH-1V. The team observed the first 30 individuals for 60 minutes, followed by telephone surveillance for the next 72 hours. The rest of the participants were monitored for 30 minutes, followed by telephone contact on the 7th.
Antibody neutralization (NAb) titers were tested by inhibitory concentration 50 (IC50) using a pseudovirion-based neutralization assay (PBNA). In addition, immunogenicity against viral ear glycoprotein was analyzed by anti-SARS-CoV-2 immunoassay. An SARS-CoV-2 (VNA) infectious neutralization test was also used to evaluate the estimated NAb titers as inhibitory dilution 50 (ID50). In addition, the increase in geometric mean fold (GMFR) and geometric mean titer (GMT) was estimated for each parameter.
Results
A total of 862 people were examined, among whom 522 adults received PHH-1V and 260 received a dose of BNT162b2 booster vaccine. In addition, the modified treatment intention cohort (mITT) included 504 PHH-1V and 248 BNT162b2, and the safety protocol (SP) cohort had 513 PHH-1V and 252 BNT162b2, and the immunogenicity population (PGI). ) had 503 immunogenicity. 1V and 246 participants BNT162b2.
The team noted that for the Wuhan SARS-CoV-2 strain, the GMT on the 14th was 3357.50 for the BNT162b2 group and 1998.95 for the PPH-1V group and had a GMT ratio of 1.68. On the other hand, the GMT ratio on day 98 was 0.87, indicating the non-inferiority of the vaccine response corresponding to PHH-1V to BNT162b2. In addition, the GMT for the SARS-CoV-2 Beta variant from day 14 was 2658.04 for the BNT162b2 group and 4328.93 for the PPH-1V group and had a GMT ratio of 0.61, which which suggested a superiority of PHH-1V over BNT162b2. On day 98 for the Beta variant, 0.57 was the GMT ratio, confirming the superiority of PHH-1V for Beta.
The team also observed that the GMT for the SARS-CoV-2 Delta variant from day 14 was 1487.13 for the BNT162b2 group and 1471.60 for the PPH-1V group and had a GMT ratio of 1.01, suggesting a non-inferiority of PHH-1V. against BNT162b2. On day 98 for the Delta variant, the GMT ratio was 0.52, indicating the superiority of PHH-1V for the Delta variant. The team also found that the GMT for the SARS-CoV-2 Omicron variant from day 14 was 1219.08 for the BNT162b2 group and 2053.73 for the PPH-1V group and had a GMT ratio of 0, 59 indicating the superiority of PHH-1V over BNT162b2 for the Omicron Variant. On day 98 for the Omicron variant, the GMT ratio was 0.56, further confirming the superiority of PHH-1V for Omicron.
The study also showed that 89.3% and 94.4% of participants belonging to the PHH-1V and BNT162b2 groups reported a minimal adverse effect, including mild symptoms in 66.7% of the cohorts. PHH-1V and 57.9% of the BNT162b2 cohorts. The most frequently experienced adverse effects included injection site pain, fatigue, and headache between the PHH-1V and BNT162b2 groups.
Conclusion
Overall, the study’s findings showed that the PHH-1V vaccine was well tolerated and safe for COVID-19 treatment while stimulating a response of solid neutralizing antibodies against the viral variants tested.
* Important news
medRxiv publishes preliminary scientific reports that are not peer-reviewed and therefore should not be considered conclusive, guided by clinical practice or health-related behavior, or treated as established information.