Cynthia A. Janak
September 20, 2011
HPV studies -- Inclusion and exclusion roulette wheel
By Cynthia A. Janak

Well, I am at it again. I am asking why the 11 year old Hispanic boy was included in the study. I was amazed at what I found as to what is presently available to me in regards to this topic.

I went to http://clinicaltrials.gov to find my answers. This was a real learning experience as to who are excluded but the vaccine is a one size fits all and administered to all even those that would have been excluded from the study.

This article is going to be a little long but the summary at the end will be well worth the wait. Trust me it sure will at least in my opinion.

The trials I am going to reference are on my favorite product Gardasil® by Merck. Here is the first study. The eligibility requirements are a little long.

I want to focus on Gardasil® (V503) but the eligibility for REPEVAX ™ is important also.

A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007 AM1)

This study has been completed
. First Received on February 19, 2010. Last Updated on June 22, 2011

Eligibility

Ages Eligible for Study: 11 Years to 15 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

  • Participant is in good health

  • Participant's parent/legal guardian can read, understand, and complete the vaccination report card

  • Participant is not sexually active and does not plan on becoming sexually active during the study

  • Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

Exclusion Criteria:

  • Participant has a known allergy to any vaccine component of V503 or REPEVAX™

  • Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine

  • Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine

  • Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine

  • Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™

  • Participant has a history of severe allergic reaction that required medical intervention

  • Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections

  • Participant is concurrently enrolled in clinical studies of investigational agents

  • Female participant is pregnant

  • Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study

  • Participant is immunocompromised, immunodeficient, or has an autoimmune condition

  • Participant has had a splenectomy

  • Participant has received immunosuppressive therapies in the prior year

  • Participant has received immune globulin product or blood-derived product in the last 3 months

  • Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination

  • Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial

  • Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years

  • Participant has a fever ≥100°F within 24 hours of vaccination

  • Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate

  • Participant and parent/legal guardian are unable to give assent/consent

  • Participant is unlikely to adhere to the study procedures or is planning to relocate during the study

  • Participant has recent history of illicit drug or alcohol abuse

  • Participant has a history of HPV

Human Papilloma Virus (HPV) Type-Specific Antibody

This study is enrolling participants by invitation only.
First Received on September 20, 2010. Last Updated on September 24, 2010

Eligibility

Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

Study Population

This will be limited to subjects who were enrolled into IMPAACT P1047 and who completed the scheduled vaccine doses for their designated arm.

Criteria

Inclusion Criteria:

  • Previous enrollment in P1047

  • Completion of the P1047 scheduled vaccine doses for their designated arm.

  • Parent or legal guardian able and willing to provide signed informed consent

  • Subjects should be between 1 and 2 years following their last HPV vaccination.

Exclusion Criteria:

  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.

  • Administration of a globulin-containing product within 90 days prior to enrollment.

  • Receipt of an additional dose of Merck HPV vaccine other than that administered for the P1047 study.

  • Receipt of GSK HPV vaccine.

Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

This study is currently recruiting participants.
Verified on February 2011 by University of Pittsburgh First Received on August 11, 2010. Last Updated on February 24, 2011

Eligibility

Ages Eligible for Study: 18 Years to 26 Years
Genders Eligible for Study: Male
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

  • Males age 18-26

Exclusion Criteria:

  • Hospitalization within the past year

  • Previous HPV vaccination

    >/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination

  • History of genital warts

  • Immunosuppression

  • Other vaccines within 8 days of proposed HPV vaccination

  • Hypersensitivity to yeast or HPV vaccine components

  • Known autoimmune disorders

  • Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)

  • Serious Adverse Reaction to HPV vaccine

Mother — Daughter Initiative (MDI) in Cervical Cancer Prevention

This study is currently recruiting participants.
Verified on June 2011 by Jhpiego

First Received on March 23, 2010. Last Updated on June 21, 2011

Further study details as provided by Jhpiego:

Primary Outcome Measures:

  • Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers [ Time Frame: 18 months ] [ Designated as safety issue: No ]

The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period. This corresponds to 4000 girls in Thailand and 4000 in Phillipines. The study will seek to understand if this level of population coverage (50%), can be achieved through encouraging women that receive cervical cancer screening to bring in their daughters or relatives for vaccination.

Secondary Outcome Measures:

  • Assess mothers' acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]

      Data on mother's knowledge of the vaccine, and intention to have their daughters vaccinated will be collected for a period of 1 year (or when the target number of 700 women/guardians is reached, whatever comes first).

      Data will be collected on:

    • Proportion of women with daughters who intend to vaccinate their daughters.

    • Proportion of daughters of screened mothers who return to receive the vaccine.

    • Proportion of girls who receive the first vaccine dose and are brought to the facility by a guardian/mother who did NOT receive cervical cancer screening

  • Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

      Programmatic data will be collected for the duration of the project, including but not limited to:

    • Cost required to implement the program

    • Logistics required to ensure supply and appropriate maintenance of vaccine

    • Human resources required to effectively administer the vaccine as part of routine services.

    • Key communication and outreach messages that effectively educate the community

Eligibility

Ages Eligible for Study: 9 Years to 13 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

  • Age 9-13 at first HPV vaccine dose

  • Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine

  • Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses

Exclusion Criteria:

  • Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine

  • Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose

  • Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.

  • Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems

  • Girls with a bleeding disorder or currently taking anticoagulants

  • Girls that have received any other vaccinations in the past 4 weeks

  • Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.

A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006 AM1)

This study is ongoing, but not recruiting participants.
First Received on January 11, 2010. Last Updated on June 22, 2011

Further study details as provided by Merck:

Primary Outcome Measures:

  • Number of participants who experience serious or non-serious adverse events [ Time Frame: Day 1 to Month 7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Number of participants who are seropositive to each of the HPV types contained in V503 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Eligibility

Ages Eligible for Study: 12 Years to 26 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Participants Age 12 to 15 Years:

  • Participant is in good health

  • Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up

  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1

  • Participant has not received any other HPV vaccine

  • Participant is not yet sexually active

Participants Age 16 to 26 Years:

  • Participant is in good health

  • Participant agrees to provide a primary telephone number for follow-up

  • Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1

  • Participant has not received any other HPV vaccine

  • Participant has never had Pap testing or has only had normal results

  • Participant has a history of 0 to 4 lifetime sexual partners at enrollment

Exclusion Criteria:

All participants:

  • Participant has a history of severe allergic reaction that required medical intervention

  • Participant has any disorder that would contraindicate intramuscular injections

  • Participant is pregnant

  • Participant is immunocompromised or has an autoimmune condition

  • Participant has had a splenectomy

  • Participant has received any immune globulin product or blood-derived product

  • Participant has participated in a HPV vaccine clinical trial

Participants Age 16 to 26 Only:

  • Participant expects to donate eggs during the study

  • Participant has a history of abnormal cervical biopsy result

  • Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer

Sorry it was so long but it was important to have all the details without omission.

First I am going to give you my favorite comments made in the criteria.

Inclusion criteria:

  • Participant is in good health

  • Participant's parent/legal guardian can read, understand, and complete the vaccination report card

  • Mother/legal guardian and daughter are both interested and willing

  • Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses

Exclusion Criteria:

  • Participant has a known allergy to any vaccine component of V503 or REPEVAX™

  • Participant has a history of severe allergic reaction that required medical intervention

  • Participant is immunocompromised, immunodeficient, or has an autoimmune condition

  • Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate

  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.

  • Hypersensitivity to yeast or HPV vaccine components

  • Known autoimmune disorders

  • Serious Adverse Reaction to HPV vaccine

  • Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine

  • Girls with a weakened immune system ... other immune system problems

  • Participant is immunocompromised or has an autoimmune condition

Let me summarize my favorites the way I see them.

To be included in the studies you better be in good health. They do not want you to have anything wrong with you while they are conducting the studies. You may have a "New Medical Condition" later but you need to be healthy now. You and your mother's willingness to participate in this vaccination study are very important also. They really do not want anyone that is not on board 100% now do they.

Even though they will be giving this vaccine to everyone you are excluded because you are allergic to something in the vaccine. That may include sulfonamide. (Ref: article, section: 11-year-old Hispanic male). Also, your allergy to any food or medicine is important so you cannot be allowed to participate for your own good.

For your own protection they do not want you to have any history or current condition that would cause you harm or jeopardize their study outcome but it is all for your protection. It doesn't matter that people with your conditions will probably be given the vaccination anyway. They just do not want to cause you harm except for maybe a "New Medical Condition."

They are going to be testing to see how the immune system reacts so to protect you, you need a strong immune system and no autoimmune disorders. You do not need to concern yourself that the vaccine will be administered to others without consideration for these medical issues.

So to everyone that is going to be receiving and/or administering the vaccine I want to assure you that the vaccine is safe for everyone except if they have a reaction to a yeast product or a previous dose of the HPV vaccine.

On behalf of the vaccine manufactures I want to thank you for your participation in this study. Don't call us. We will call you.

Interests: I am a board member of the Truth About Gardasil and have no other affiliations with any other group.

© Cynthia A. Janak

 

The views expressed by RenewAmerica columnists are their own and do not necessarily reflect the position of RenewAmerica or its affiliates.
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Cynthia A. Janak

Cynthia Janak is a freelance journalist, mother of three, foster mother of one, grandmother of five, business owner, Chamber of Commerce member... (more)

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