Immunogenicity and safety of a bivalent, adjuvant system 04-adjuvanted human papillomavirus vaccine in healthy female volunteers aged 15-25: a randomized, double-blind, phase III, noninferiority clinical trial.

OBJECTIVE: Vaccination is proven to significantly reduce the risk of human papillomavirus (HPV)-related complications, especially cervical cancer. This study aimed to assess the immunogenicity and safety of the investigational bivalent HPV vaccine (16/18), named Papilloguard (Noyan Pajouhan Biopharma, Tehran, Iran), in comparison with the reference product (Cervarix, bivalent HPV vaccine (16/18) manufactured by GlaxoSmithKline, Rixensart, Belgium) in a three-dose regimen. METHODS: This trial was a randomized, controlled, double-blind, phase III study of two HPV vaccines in healthy female volunteers aged 15-25. The primary endpoint was to test the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) as measured by the geometric mean titer (GMT) ratios of HPV-16 and HPV-18 7 months after the first vaccination. Secondary endpoints were the proportion of local and systemic solicited and unsolicited events, and the number of females with seroconversion against HPV-16 and HPV-18 7 months after the first vaccination. RESULTS: Out of 504 screened women, 218 were enrolled. Seven months after the first vaccination, GMT ratios of HPV-16 and HPV-18 were 0.59 and 0.93, respectively. The seroconversion rates of both Papilloguard (Noyan Pajouhan Biopharma) and Cervarix (GlaxoSmithKline) were more than 96%. Both vaccinated groups had a generally good profile of solicited and unsolicited adverse events (AEs). The most common AE was discomfort at the injection site, which was well tolerated. CONCLUSION: The result analysis of this study supports the noninferiority of Papilloguard (Noyan Pajouhan Biopharma) to Cervarix (GlaxoSmithKline) in terms of safety and immunogenicity based on the GMT ratio. However, long-term comparative studies to evaluate the sustainability of GMT response and risk of cervical intraepithelial neoplasia grades 2-3 are needed.

Evaluation of the safety and efficacy of a biosimilar abobotulinum toxin type A in treating moderate-to-severe glabellar lines: A non-inferiority double blinded randomized controlled trial.

BACKGROUND: Injection of botulinum toxin for cosmetic purposes is a well-established practice. OBJECTIVES: This study was conducted to compare the safety and efficacy of Dyston® (investigational biosimilar abobotulinumtoxinA) with Dysport® (abobotulinumtoxinA, Ipsen) in the treatment of moderate-to-severe glabellar lines. METHODS: Out of 193 screened subjects, 126 volunteers with moderate-to-severe glabellar lines fulfilling eligibility criteria were randomized in a 1:1 ratio to receive either an intramuscular injection of 40-60 units of Dyston® or Dysport® . The primary objective was to test the non-inferiority of Dyston® compared with Dysport® as measured by the percentage of volunteers who achieved no or mild glabellar lines at maximum frown assessed by the physicians based on the Glabellar Line Severity Score (GLSS) at Day 30. Secondary endpoints included the improvement in the glabellar lines at maximum frown and rest states at Days 14, 60, 90, and 120 as well as the side effects of the treatment. RESULTS: Response rates at maximum frown were 75.44% (43/57) in the Dyston® group and 76.67% (46/60) in the Dysport® group on Day 30 (p value: 0.88, 95% CI: -14.24 to 16.70, diff: 1.23) as per-protocol set, and were 75.81% (47/62) and 76.19 (48/63) (p value: 0.96, 95% CI: -14.59 to 15.35, diff: 0.3) in the Dyston® and the Dysport® groups, respectively, based on modified intention to treat population. Adverse events were similar in both groups and mostly mild and well-tolerated. CONCLUSION: Treatment of moderate-to-severe glabellar lines with Dyston® was effective, tolerable, and non-inferior compared with Dysport® .