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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intramuscular injection (NS-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe (NS-IM) | ||
| PharmaJet needle-free Stratis device (JI-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device (JI-IM) | ||
| PharmaJet needle-free Tropis device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device (JI-ID) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | Up to 7 months |
| Percentage of Participants With a Demonstrated Seroconversion for HPV 18 |
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Inclusion Criteria:
Exclusion Criteria:
- Does not satisfy all of the inclusion criteria
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The study was for women and focused on the safety and immunogenicity of the HPV vaccine. Separate studies will be done in men if the dosing regimens in Groups II or III are shown to be non-inferior to the standard regimen
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| Name | Affiliation | Role |
|---|---|---|
| Joel Palefsky, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94062 | United States | ||
| Thai Red Cross AIDS Research Centre |
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161 women visiting the Thai Red Cross Anonymous Clinic between February 2014 and April 2014 were invited to participate in the study and were screened after providing informed consent. Eleven women were determined to be ineligible
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Intramuscular Injection (NS-IM) | Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe |
| FG001 | PharmaJet Needle-free Stratis Device (JI-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device |
| FG002 | PharmaJet Needle-free Tropis Device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Intramuscular Injection (NS-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe |
| BG001 | PharmaJet Needle-free Stratis Device (JI-IM) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Baseline, up to 1 day |
|
Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Intramuscular Injection (NS-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joel Palefsky, MD | University of California, San Francisco | (415) 476-8885 | Joel.Palefsy@ucsf.edu |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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.
| 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 | 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 | 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 | 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 | 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 | Up to 7 months |
| Bangkok |
| Thailand |
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
| BG002 | PharmaJet Needle-free Tropis Device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Positive cervical HPV DNA at Baseline | A larger proportion of cases of cervical cancer are caused by infection with HPV types 16 or 18 . HPV types 6 and 11 are low-risk types and cause a majority of anogenital warts in women and men | Count of Participants | Participants |
|
| Number of HPV genotypes detected at Baseline | Persons can be infected with more than one HPV genotype | Count of Participants | Participants |
|
| OG002 | PharmaJet Needle-free Tropis Device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device |
|
|
| Primary | 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. | Posted | Number | percentage of participants | Up to 7 months |
|
|
|
| Primary | 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. | Posted | Number | percentage of participants | Up to 7 months |
|
|
|
| Primary | 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. | Posted | Number | percentage of participants | Up to 7 months |
|
|
|
| Primary | 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. | Posted | Number | percentage of participants | Up to 7 months |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mMU/mL | Up to 7 months |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mMU/mL | Up to 7 months |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mMU/mL | Up to 7 months |
|
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | mMU/mL | Up to 7 months |
|
|
|
| Primary | 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 | Posted | Number | 95% Confidence Interval | ratio | Up to 7 months |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| 45 |
| 50 |
| EG001 | PharmaJet Needle-free Stratis Device (JI-IM) | HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device | 0 | 50 | 3 | 50 | 46 | 50 |
| EG002 | PharmaJet Needle-free Tropis Device (JI-ID) | HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device | 0 | 50 | 2 | 50 | 36 | 50 |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Swelling | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Arm movement limitation | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Erythema | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Induration | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
|
|
|
| HPV-16 |
|
| HPV-18 |
|