mRNA-1273 Vaccine-elicited Neutralization of SARS-CoV-2 Omicron in Adolescents and Children

  1. Bethany Girard
  2. Joanne E Tomassini
  3. Weiping Deng
  4. Maha Maglinao
  5. Honghong Zhou
  6. Amparo Figueroa
  7. Sabine Schnyder Ghamloush
  8. David C Montefiori
  9. Rituparna Das
  10. Rolando Pajon

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Abstract

Background

The highly transmissible severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Omicron variant is a global concern. This study assessed the neutralization activity of two-dose regimens of mRNA-1273 vaccination against Omicron in adults, adolescents and children.

Methods

Neutralizing activity against the Omicron variant was evaluated in serum samples from adults (≥18 years) in the phase 3, Coronavirus Efficacy (COVE) and from adolescents (12-17 years) in the TeenCOVE trials following a two-dose regimen of 100 µg mRNA-1273 and from children (6-<12 years) in the KidCOVE trial administered two doses of 50 µg mRNA-1273. Neutralizing antibody geometric mean ID50 titers (GMT) were measured using a lentivirus-based pseudovirus neutralizing assay at day 1 and 4 weeks (day 57) following the second mRNA-1273 dose, compared with wild-type (D614G).

Results

At 4 weeks following a second dose of mRNA-1273 (100 µg), the GMT was reduced 28.8-fold compared with D614G in adults (≥18 years). In adolescents (12-17 years), the GMT was 11.8-fold lower than D614G, 4 weeks after a second dose of mRNA-1273 (100 µg), and compared with adults, were 1.5- and 3.8-fold higher for D614G and the Omicron variant, respectively. In children (6-<12 years), 4 weeks post-second dose of 50 µg mRNA-1273, Omicron GMTs were reduced 22.1-fold versus D614G and were 2.0-fold higher for D614G and 2.5-fold higher for Omicron compared with adults.

Conclusions

A two-dose regimen of 100 µg mRNA-1273 in adolescents and of 50 µg in children elicited neutralization responses against the Omicron variant that were reduced compared with the wild-type D614G, and numerically higher than those in adults.

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  1. ScreenIT

    SciScore for 10.1101/2022.01.24.22269666: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The central Institutional Review Board/Ethics Committee, Advarra, Inc., 6100 Merriweather Drive, Columbia, MD 21044 approved the protocol and consent forms.
    Consent: All participants provided written informed consent.
    Sex as a biological variablenot detected.
    RandomizationSelection of Clinical Trial Participant Samples: Serum samples for testing in the immunogenicity subset were randomly selected from healthy adult participants (≥18 years) who completed a primary vaccination series of two doses of 100 µg mRNA-1273 in the blinded Part A of the phase 3 COVE5,6 and in adolescents (12-17 years) in the blinded Part A of the phase 2/3 TeenCOVE3 trials, and children 6-<12 years who received 2 doses of 50 µg mRNA in the open-label Part 1 of the KidCOVE trial (Table S1).
    BlindingSelection of Clinical Trial Participant Samples: Serum samples for testing in the immunogenicity subset were randomly selected from healthy adult participants (≥18 years) who completed a primary vaccination series of two doses of 100 µg mRNA-1273 in the blinded Part A of the phase 3 COVE5,6 and in adolescents (12-17 years) in the blinded Part A of the phase 2/3 TeenCOVE3 trials, and children 6-<12 years who received 2 doses of 50 µg mRNA in the open-label Part 1 of the KidCOVE trial (Table S1).
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    293T/ACE2-MF cells were detached from T75 culture flasks using TrypLE Select Enzyme solution, suspended in growth medium (100,000 cells/ml) and immediately added to all wells (10,000 cells in 100 µL of growth medium per well).
    293T/ACE2-MF
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04470427Active, not recruitingA Study to Evaluate Efficacy, Safety, and Immunogenicity of …
    NCT04649151Active, not recruitingA Study to Evaluate the Safety, Reactogenicity, and Effectiv…
    NCT04796896RecruitingA Study to Evaluate Safety and Effectiveness of mRNA-1273 CO…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  2. Version published to 10.1101/2022.01.24.22269666v1 on medRxiv