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Completed

NCT Number: NCT01924754

Gardasil Immunogenicity With Needle-Free Injection

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.

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Key information

Conditions

HPV Seroconversion Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–26 year

Sex eligibility

Female

Study type

Observational

Primary location

Thai Red Cross AIDS Research Centre, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not satisfy all of the inclusion criteria

Treatment and study plan

Primary outcomes

  1. Number of Participants With Geometric Mean Antibody Concentrations by HPV Type

    Time frame: Baseline, up to 1 day

    Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type

  2. Percentage of Participants With a Demonstrated Seroconversion for HPV 6

    Time frame: 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.

  3. Percentage of Participants With a Demonstrated Seroconversion for HPV 11

    Time frame: 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.

  4. Percentage of Participants With a Demonstrated Seroconversion for HPV 16

    Time frame: 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.

  5. Percentage of Participants With a Demonstrated Seroconversion for HPV 18

    Time frame: 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.

  6. Median Concentration for HPV 6 Over Time

    Time frame: Up to 7 months

    The median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated

  7. Median Concentration for HPV 11 Over Time

    Time frame: Up to 7 months

    The median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated

  8. Median Concentration for HPV 16 Over Time

    Time frame: Up to 7 months

    The median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated

  9. Median Concentration for HPV 18 Over Time

    Time frame: Up to 7 months

    The median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated

  10. Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

GINI: Gardasil Immunogenicity With Needle-free Injection-Safety and Immunogenicity of Gardasil Using IM and ID Needle-free Injection Delivery

Acronym: GINI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2013
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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