Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial

Remon Abu-Elyazeed, Nicola P. Klein, Leentje Moerman, Michael Povey, Anthony Pruitt, Shelly Senders, Peter Silas, Dan Bi, Armando Acevedo, Rogelio Amisola, Luke Anschutz, Regine Bataille, James Campbell, Matthew Cornish, Joseph Domachowske, John Fling, Earl Franklin, Joshua Fuller, Alvin Gabrielsen, Alan GarscaddenGiancarlo Guido, James Hedrick, David Hurley, Donald Hurley, William Johnston, Aarti Kulshrestha, Michael Leonardi, Martin Levinson, Sean Livingston, Gary Marshall, Paola Pirrotta, Walter Rok, Stephen Russell, Martin Schear, Julie Shepard, Laurent Sigg, Tina Singh, Mary Tipton, Ana Ugarte, Paul Wisman, Edward Zissman

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV previously showed immunogenicity and safety profiles comparable to lyophilized (Lyo) HRV. Methods: This was a phase 3a, randomized, single-blind study (NCT03207750) conducted in the United States. Healthy infants aged 6–12 weeks received 2 doses (0, 2 months) of either Liq PCV-free HRV or Lyo HRV with routine vaccines (0, 2, 4 months): diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus combination vaccine (DTaP-HBV-IPV), monovalent tetanus toxoid-conjugated vaccine against Haemophilus influenzae type b (Hib-TT), and 13-valent pneumococcal conjugate vaccine. Co-primary objectives were: (i) to assess non-inferiority of immune responses to routine vaccine antigens 1 month post-dose 3 following co-administration with Liq PCV-free HRV compared to Lyo HRV; (ii) to rule out a 10% decrease in seroresponse to pertussis antigens after dose 3. Other objectives were to evaluate immunogenicity and safety of HRV vaccines. Results: Of 1272 vaccinated infants, 990 (489 in Liq PCV-free HRV and 501 in Lyo HRV group) were included in the per-protocol set. All statistical criteria were met, thus co-primary objectives were demonstrated. Seroprotection/seropositivity rates in both groups were high: 100% for diphtheria/tetanus, ≥99.3% for HBV, ≥99.8% for polio, ≥99.8% for each pertussis antigen, ≥90.8% for all pneumococcal serotypes except serotype 3 (≥69.1%), and ≥ 97.4% for Hib. Most infants seroconverted for anti-RV antibodies (76.3% of Liq PCV-free HRV and 78.9% of Lyo HRV recipients). Geometric mean concentrations/titers were comparable between groups. Incidences of adverse events and serious adverse events were similar between groups. Conclusion: Routine pediatric vaccines co-administered with Liq PCV-free HRV showed non-inferior immune responses and similar safety profiles to those following co-administration with Lyo HRV.

Original languageEnglish
Pages (from-to)1534-1543
Number of pages10
JournalVaccine
Volume39
Issue number10
DOIs
StatePublished - 5 Mar 2021

Keywords

  • Concomitant administration
  • Human rotavirus vaccine
  • Non-inferiority
  • Porcine virus-free rotavirus vaccine
  • Routine childhood vaccines

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