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.
Primary Objectives 1. 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. 2. 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.
Study Type
OBSERVATIONAL
Enrollment
150
University of California, San Francisco
San Francisco, California, United States
Thai Red Cross AIDS Research Centre
Bangkok, Thailand
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Time frame: Baseline, up to 1 day
Percentage of Participants With a Demonstrated Seroconversion for HPV 6
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.
Time frame: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 11
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.
Time frame: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 16
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.
Time frame: Up to 7 months
Percentage of Participants With a Demonstrated Seroconversion for HPV 18
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.
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Time frame: Up to 7 months
Median Concentration for HPV 6 Over Time
The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated
Time frame: Up to 7 months
Median Concentration for HPV 11 Over Time
The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated
Time frame: Up to 7 months
Median Concentration for HPV 16 Over Time
The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated
Time frame: Up to 7 months
Median Concentration for HPV 18 Over Time
The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated
Time frame: Up to 7 months
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
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
Time frame: Up to 7 months