Background: Data from previous studies of the MVC-COV1901 vaccine, a subunit vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on the stable prefusion spike protein (S-2P) adjuvanted with CpG 1018 adjuvant and aluminum hydroxide, suggest that the vaccine is generally safe and elicits a good immune response in healthy adult and adolescents. By comparing with the active control, AZD1222, this study adds to the findings from previous trials and further evaluates the breadth of protection offered by MVC-COV1901.
Methods: In this phase 3, parallel group, randomized, double-blind, active-controlled trial conducted in 2 sites in Paraguay, we assigned adults aged 18 to 91 years in a 1:1 ratio to receive intramuscular doses of MVC-COV1901 or AZD1222 administered as scheduled in the clinical trial. Serum samples were collected on the day of vaccination, Day 1, and 14 days after the second dose (Day 43 after first dose). Primary and secondary safety and immunogenicity endpoints were assessed. In addition, other outcomes investigated were cross-reactive immunity against the Omicron strain and non-neutralizing antibody immune effector mechanisms particularly the induction of IgG subclasses.
Results: A total of 1,030 participants underwent randomization. Safety data was derived from this set while primary immunogenicity data involved a per-protocol immunogenicity (PPI) subset including 225 participants. Among the participants, 58% are seropositive at baseline. The mean age was 32.1 years and approximately 60% were males. An estimated 35.3% of participants had coexisiting medical conditions. When compared against AZD1222, MVC-COV1901 exhibited superiority in terms of neutralizing antibody titers geometric mean titer ratio (GMTR) [GMTR seronegative: 4.8 (95% CI 3.0-7.7); GMTR seropositive: 1.7 (95% CI 1.2-2.2)] and non-inferiority in terms of seroconversion rates. Reactogenicity was generally mild. The incidence of serious adverse events was low in both groups. Both vaccines have a Th1-biased response that is predominated by the production of IgG1 and IgG3 subclasses-with MVC-COV1901 exhibiting a stronger antibody response. In the pseudovirus assay, Omicron-neutralizing titers were 44.5 times lower compared to wildtype-neutralizing titers among seronegative individuals at baseline. This fold-reduction was reduced to 3.0 times among the seropositive.
Conclusion: Safety and immunogenicity data presented here demonstrate the safe and robust immunogenicity from MVC-COV1901. Previous infection coupled with vaccination of this vaccine may offer protection against the Omicron strain though its durability is still unknown.
18Esta Unidad podría dar continuidad a los programas de seguimiento de egresados y de valoración del impacto que tienen los mismos en la salud, la ciencia y la enseñanza de la ciencia médica a nivel local y regional.ABSTRACT Introduction: One way to assess the result and the relevance of a curriculum is through the followup of graduates. This is a fundamental task in the management of a higher education institution. Objective: The objective of the present follow-up report was to know and monitor the labor insertion
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