A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine
Condition: Human Papilloma Virus Infection
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Phase 2

Summary: 
      This trail is to evaluate the safety profile of Recombinant Nonavalent (Types
      6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy
      Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the
      investigational vaccine. Besides, the trail is also to demonstrate that the levels of
      neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the
      investigational vaccine with the chosen optimal antigen ratio are superior to those induced
      by Gardasil.
    

Detailed description: 
      This is a single-center, blinded, randomized and Gardasil-controlled (quadrivalent HPV
      vaccine GARDASIL®) Phase II clinical trial.

      The trial will recruit a total of approximately 780 Chinese women 20-45 years of age with
      permanent residence. Healthy women ages 20-45 eligible for the trial will be stratified at a
      1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each
      subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational
      vaccine, high-dosage investigational vaccine or the positive control (quadrivalent HPV
      vaccine GARDASIL®), respectively.

      Each subject will be administered 0.5 ml of the investigational vaccine or control in
      accordance with a 3-dose regimen at months 0, 2 and 6.

      Peripheral blood samples of each subject will be collected at Day 0 (prior to dose 1), Month
      7 (1 month post dose 3) to determine the levels of neutralizing antibodies and IgG antibodies
      to HPV types 6/11/16/18/31/33/45/52/58 in the sera. Optimal ratio of the antigens included in
      the investigational vaccine will be decided based on the immunogenicity and safety data from
      this trail.
    

Intervention name(s): Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli); Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)
Intervention type(s): Biological; Biological
Intervention description(s): For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6.
For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.; A 3-dose regimen administered at months 0, 2 and 6.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy women ages 20-45 eligible for the trial will be stratified at a 1: 1 ratio into 2 age subgroups (20-30 years of age and 31-45 years of age), and each subgroup will be randomized at a 1: 1: 1 ratio to receive the mid-dosage investigational vaccine, high-dosage investigational vaccine or the positive control, respectively.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: CIN; VIN; VaIN; AIN; Cervical cancer; Vulvar cancer; Anal cancer; Genital warts