GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a Demonstrated Seroconversion for HPV 11
研究概览
简要总结
Using biospecimens collected in a trial by the Thai Red Cross AIDS Research Center that studied two new human papillomavirus (HPV) vaccine delivery regimens, the investigators at UCSF will be testing the serum for antibodies to measure the strength of their response to the vaccine.
详细描述
Primary Objectives
- Compared rates of seroconversion and geometric mean titers (GMTs) generated following a 3-dose series of vaccine in women given low doses of vaccine by the intradermal (ID) route with the needle-free injector (NFI) (Group III) to those women given standard doses by the intramuscular (IM) route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
- Compared rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 12 months following completion of the vaccination series.
Serum samples were collected on 4 successive occasions: (1) day zero, prior to the first immunization, (2) at visit 4, one month following the third and final immunization, (3) at visit 5 (12 months) and (4) and at visit 6 (24 months after enrollment). Samples were split, stored and transferred in batch for analysis.
Merck received samples for processing and determined the geometric mean titer of antibodies specific to HPV (types 6, 11, 16, and 18) and results were transferred to the principal investigator. The University of California, San Francisco (UCSF) used a portion of the collected blood samples for pseudovirion-based neutralisation assay (PBNA) analysis conducted at UCSF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thai women age 18-26 years
- •No more than 5 lifetime sexual partners
- •HIV-uninfected
- •No history of HPV vaccination
- •Judged able to complete all of the protocol visits
- •No contraindications to vaccination with Gardasil
排除标准
- •Does not satisfy all of the inclusion criteria
结局指标
主要结局
Percentage of Participants With a Demonstrated Seroconversion for HPV 11
时间窗: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 11 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Percentage of Participants With a Demonstrated Seroconversion for HPV 6
时间窗: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 6 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Median Concentration for HPV 11 Over Time
时间窗: Up to 7 months
The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated
Median Concentration for HPV 18 Over Time
时间窗: Up to 7 months
The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated
Percentage of Participants With a Demonstrated Seroconversion for HPV 18
时间窗: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 18 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Median Concentration for HPV 6 Over Time
时间窗: Up to 7 months
The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
时间窗: Baseline, up to 1 day
Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Median Concentration for HPV 16 Over Time
时间窗: Up to 7 months
The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated
Percentage of Participants With a Demonstrated Seroconversion for HPV 16
时间窗: Up to 7 months
The percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 16 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
时间窗: Up to 7 months
The Geometric Mean Concentration Ratio (GMCR) and 95% confidence interval for both NS-IM versus JI-IM and NS-IM versus JI-ID was computed for the intent to treat population. Non-inferiority for arms JI-IM and JI-ID was defined as geometric mean concentration ratio (GMCR) \<1.5 of NS-IM at month 7
次要结局
未报告次要终点