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COVID-19 Management

RCT Results: Which COVID-19 Vaccines Can be Used for Boosters?

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BACKGROUND AND PURPOSE:

  • Munro et al. (The Lancet, 2021) investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford–AstraZeneca) or BNT162b2 (Pfizer–BioNtech)

METHODS:

  • Multicenter, randomized, controlled phase 2 trial
  • Participants
    • >30 years of age
    • No history of laboratory confirmed SARS-CoV-2 infection
    • Time from primary dosing
      • ≥70 days post two doses of AstraZeneca or
      • ≥84 days post two doses of Pfizer
  • Interventions
    • Three groups (A, B, and C) across 18 sites
    • Within each group, participants were assigned an experimental vaccine as a third dose, or a control
      • Group A
        • NVX-CoV2373 (Novavax) | Subunit protein vaccine
        • Half-dose of Novavax
        • AstraZeneca | Viral vector vaccine
        • Control: quadrivalent meningococcal conjugate vaccine (MenACWY)
      • Group B
        • Pfizer | mRNA vaccine
        • VLA2001 (Valneva) | Inactivated whole virus vaccine
        • Half-dose of Valneva
        • Ad26.COV2.S (Janssen) | Viral vector vaccine
        • Control: MenACWY
      • Group C
        • Moderna | mRNA vaccine
        • CVnCov (CureVac) | mRNA vaccine
        • Half-dose of Pfizer
        • Control MenACWY
  • Study design
    • All participants and investigators were blinded to treatment
    • Primary analysis for immunogenicity was on a modified intention-to-treat basis, and safety and reactogenicity were assessed in the intention-to-treat population
  • Primary outcome
    • Safety
    • Reactogenicity and immunogenicity of anti-spike IgG
  • Secondary outcomes
    • Viral neutralization
    • Cellular responses

RESULTS:

  • 2878 participants
    • AstraZeneca primed patients:
      • Younger age group: Median (IQR) 53 (44 to 61) years
      • Older age group: Median (IQR) 76 (73 to 78) years
      • 46.7% female | 95.4% White
    • Pfizer primed patients
      • Younger age group: Median (IQR) 51 (51 to 59) years
      • Older age group: Median (IQR) 78 (75 to 82) years
      • 53.6% female | 91.9% White

Reactogenicity and immunogenicity

  • Three vaccines series showed overall increased reactogenicity
    • Moderna after AstraZeneca
    • Moderna after Pfizer
    • AstraZeneca and Janssen after Pfizer

AstraZeneca Primed Individuals

  • Range of IgG levels varied between study vaccines and controls
    • Low: Valneva
    • High: Moderna
  • Range in cellular responses
    • Low: AstraZeneca
    • High: Moderna

Pfizer Primed Individuals

  • Range of IgG levels varied by vaccine and controls
    • Low: Valneva
    • High: Moderna
  • Range in cellular responses
    • Low: Half-dose Valneva
    • High: Moderna

Note:

  • The results were similar between those aged 30 to 69 years and ≥70 years
  • Vaccines that produced antibodies against the initial wild-type appear to also neutralize delta effectively in vitro “to a consistent, but slightly lesser degree”

Safety 

  • Most common local and systemic adverse events
    • Fatigue
    • Pain
  • These adverse events were experienced more in people aged 30 to 69 than those ≥70 years
  • Serious adverse events were uncommon
    • Control: 5 events
    • Janssen: 2 events
    • Valneva: 5 events
    • Half-dose Valneva: 1 event
    • Pfizer: 1 event
    • Half-dose Pfizer: 2 events
    • AstraZeneca: 2 events
    • CureVac: 1 event
    • Novavax: 2 events
    • Half-dose Novavax: 2 events
    • Moderna: 1 event

CONCLUSION:

  • All 7 vaccines tested (AstraZeneca, Pfizer, m1273, NVX, Ad26, CVn, and VAL) boosted immunity following AstraZeneca series
  • 6 vaccines (AstraZeneca, Pfizer, m1273, NVX, Ad26, and CVn) boosted immunity following a Pfizer series
  • There were no safety issues
  • The authors state

These data are consistent with early data from other trials of homologous and heterologous third dose boosters

Learn More – Primary Sources:

Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial

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Related ObG Topics:

Effectiveness of the Pfizer mRNA COVID-19 Booster Dose
Breakthrough COVID-19 Following Vaccination: What are the Risk Factors?
AstraZeneca First Dose and mRNA Second Dose: How Does the ‘Mix & Match’ Immune Response Stack Up?

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