Two cohorts of vaccinated NHPs received a booster immunization after randomizing each group within a cohort based on their baseline characteristics (Fig.
In the mRNA-primed cohort, six adult male and six adult female Mauritius cynomolgus macaques (Macaca fascicularis) aged 4–10 years, selected based on their responses to the primary vaccination, were randomly allocated to three groups of four animals according to their baseline characteristics.
In the subunit-primed cohort, 15 adult male Indian rhesus macaques (Macaca mulatta) aged 4–7 years were randomly allocated to three groups of five animals. In the priming phase, animals received two immunizations of either Sanofi’s mRNA COVID (ancestral D614) experimental candidate vaccines or CoV2 preS dTM-AS03 (ancestral D614) vaccine through the intramuscular route in the deltoid at day 0 and day 21. Seven months after the primary immunization, both cohorts were immunized with CoV2 preS dTM (ancestral)–AS03, CoV2 preS dTM (Beta)–AS03, and a bivalent CoV2 preS dTM (ancestral + Beta)–AS03. All groups received a total dose of 5 µg of CoV2 preS dTM antigen. All immunologic analyses were performed blinded on serum collected at 7, 14, 21, 28, 56, 84 days, and 6 months post-boost injection for D614G and Beta seroneutralizations; on D14, 56, 84, and 6 months for Delta; on D14 and 6 months for Omicron (BA.1), Omicron BA.4/5, and SARS-CoV1. Animal studies were conducted in compliance with all relevant local, state, and federal regulations, and were approved by the New Iberia Research Center.