{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T13:26:12Z","timestamp":1794317172052,"version":"4.9.0"},"reference-count":47,"publisher":"American Academy of Pediatrics (AAP)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND AND OBJECTIVES<\/jats:title>\n                    <jats:p>PHH-1V, a protein-based, non-mRNA, bivalent, adjuvanted COVID-19 vaccine, has demonstrated strong immunogenicity and favorable safety as a booster in adults. This study evaluated PHH-1V as a heterologous booster in adolescents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>HIPRA-HH-3 was a phase IIb, open-label, multicenter, noninferiority trial assessing the immunogenicity and safety of PHH-1V in 240 healthy adolescents (\u2265\u200912 to &amp;lt;\u200918 years) primed with BNT162b2. Immunogenicity (N\u2009=\u200990) was assessed by measuring neutralizing antibodies against SARS-CoV-2 variants and total binding antibodies in adolescent participants vs young adults (\u2265\u200918 to \u2264 25 years) (N\u2009=\u200981) from a previous trial, who had also been boosted with PHH-1V. T-cell responses at day 14 post booster were also evaluated. Antibody durability and adverse events (AEs) were assessed through day 336.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Neutralizing titers\u2014against Omicron BA.1 (primary endpoint), WH1, Beta, and Delta variants\u2014and total binding antibodies were significantly higher in adolescents than in young adults (P\u2009&amp;lt;\u2009.001), demonstrating noninferiority (margin\u00a0&amp;lt;\u00a01.5). T-cell responses against BA.1 and Beta also increased significantly (P\u2009&amp;lt;\u2009.001). Cross-variant antibody titers remained above baseline (day 0) through day 336. AEs were mostly mild\/moderate, primarily injection-site pain and headache within 28 days. No related serious AEs were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>As a heterologous booster in adolescents, PHH-1V is safe and elicits cellular and sustained humoral responses with cross-variant immune recognition, which support the use of PHH-1V in adolescent vaccination strategies. Data in younger and specific risk groups are still needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1542\/peds.2026-076225","type":"journal-article","created":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T00:03:07Z","timestamp":1792713787000},"source":"Crossref","is-referenced-by-count":0,"title":["Immunogenicity and Safety of PHH-1V COVID-19 Vaccine as a Heterologous Booster in Adolescents"],"prefix":"10.1542","volume":"158","author":[{"given":"Ignasi","family":"Esteban Riera","sequence":"first","affiliation":[{"name":"1Institut d\u2019Investigacions Biom\u00e8diques August Pi i Sunyer (IDIBAPS), Hospital Cl\u00ednic, University of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ra\u00fal","family":"P\u00e9rez-Caballero","sequence":"additional","affiliation":[{"name":"2IrsiCaixa, Badalona, Barcelona, Spain"},{"name":"3Germans Trias i Pujol Research Institute (IGTP), Badalona, 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