Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9–14 years of age: Interim analysis from a phase 3 clinical trial

• Published in: Vaccine Vol. 42; no. 9; pp. 2290 - 2298
• Main Authors: Zaman, Khalequ, Schuind, Anne E, Adjei, Samuel, Antony, Kalpana, Aponte, John J, Buabeng, Patrick BY, Qadri, Firdausi, Kemp, Troy J, Hossain, Lokman, Pinto, Ligia A, Sukraw, Kristen, Bhat, Niranjan, Agbenyega, Tsiri
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 02-04-2024; Elsevier Limited; Elsevier Science
• Subjects: Adverse events; Age; Aluminum; Antigens; Cervical cancer; Clinical trials; Consent; Dosage; Enzyme-linked immunosorbent assay; HPV vaccine; Human papillomavirus; Human papillomavirus (HPV); Immunization; Immunobridging; Immunogenicity; Immunology; Infections; Medical research; Neutralization; One-dose immunogenicity; Pediatrics; Proteins; Safety; Schedules; Serology; Vaccines; Womens health; United States > US; Bangladesh; Ghana; Immunization; Human papillomavirus (HPV); One-dose immunogenicity; HPV vaccine; Immunobridging
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2024.02.077

•Innovax bivalent HPV vaccine (Cecolin), and Gardasil have similar safety profiles.•Two Cecolin doses six months apart are immunologically non-inferior to Gardasil.•Six months after one dose, Cecolin is highly immunogenic.•Cecolin expands the options for HPV vaccination in low- and middle-income countries.
World Health Organization human papillomavirus (HPV) vaccination recommendations include a single- or two-dose schedule in individuals 9–20 years old and advice for generating data on single-dose efficacy or immunobridging. The ongoing Phase 3 trial of Innovax’s bivalent (types 16 and 18) HPV vaccine (Cecolin®) assesses in low- and middle-income countries alternative dosing schedules and generates data following one dose in girls 9–14 years old. Interim data for the 6-month dosing groups are presented.
In Bangladesh and Ghana, 1,025 girls were randomized to receive either two doses of Cecolin at 6-, 12-, or 24-month intervals; one dose of Gardasil® followed by one dose of Cecolin at month 24; or two doses of Gardasil 6 months apart (referent). Serology was measured by enzyme-linked immunosorbent assay (ELISA) and, in a subset, by neutralization assays. Primary objectives include immunological non-inferiority of the Cecolin schedules to referent one month after the second dose. Safety endpoints include reactogenicity and unsolicited adverse events for 7 and 30 days post-vaccination, respectively, as well as serious adverse events throughout the study.
Interim analyses included data from the two groups on a 0, 6-month schedule with 205 participants per group. One month after Dose 2, 100% of participants were seropositive by ELISA and had seroconverted for both antigens. Non-inferiority of Cecolin to Gardasil was demonstrated. Six months following one dose, over 96% of participants were seropositive by ELISA for both HPV antigens, with a trend for higher geometric mean concentration following Cecolin administration. Reactogenicity and safety were comparable between both vaccines.
Cecolin in a 0, 6-month schedule elicits robust immunogenicity. Non-inferiority to Gardasil was demonstrated one month after a 0, 6-month schedule. Immunogenicity following one dose was comparable to Gardasil up to six months. Both vaccines were safe and well tolerated (ClinicalTrials.gov No. 04508309).