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SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses.

Authors :: Branche AR
Rouphael NG
Diemert DJ
Falsey AR
Losada C
Baden LR
Frey SE
Whitaker JA
Little SJ
Anderson EJ
Walter EB
Novak RM
Rupp R
Jackson LA
Babu TM
Kottkamp AC
Luetkemeyer AF
Immergluck LC
Presti RM
Bäcker M
Winokur PL
Mahgoub SM
Goepfert PA
Fusco DN
Malkin E
Bethony JM
Walsh EE
Graciaa DS
Samaha H
Sherman AC
Walsh SR
Abate G
Oikonomopoulou Z
El Sahly HM
Martin TCS
Rostad CA
Smith MJ
Ladner BG
Porterfield L
Dunstan M
Wald A
Davis T
Atmar RL
Mulligan MJ
Lyke KE
Posavad CM
Meagher MA
Stephens DS
Neuzil KM
Abebe K
Hill H
Albert J
Lewis TC
Giebeig LA
Eaton A
Netzl A
Wilks SH
Türeli S
Makhene M
Crandon S
Lee M
Nayak SU
Montefiori DC
Makowski M
Smith DJ
Roberts PC
Beigel JH
Source :: MedRxiv : the preprint server for health sciences [medRxiv] 2022 Jul 15. Date of Electronic Publication: 2022 Jul 15.
Publication Year :: 2022
Abstract: Background: Protection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines.<br />Methods: This phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID <subscript>50</subscript> ) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination.<br />Results: From March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907).<br />Conclusions: Higher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines.<br />Clinicaltrialsgov: NCT05289037.