Autologous Vaccine for Use Agains Papilloma

Human Papillomavirus (HPV)

Disease Issues Contraindications and Precautions Vaccine Recommendations Vaccine Safety Scheduling and Administering Vaccines Storage and Handling

Disease Issues

How common is human papillomavirus (HPV) infection?

HPV is the most common sexually transmitted infection in the United States. In the United States, an estimated 79 million persons are infected, and an estimated 14 million new HPV infections occur every year among persons age 15 through 59 years. Approximately half of new infections occur among persons age 15 through 24 years. First HPV infection occurs within a few months to years of becoming sexually active.

How serious is disease caused by HPV?

Most HPV infections are asymptomatic and go away completely on their own within 2 years after infection without causing clinical disease. Some infections are persistent and can lead to precancerous lesions or cancer. HPV infection caused by certain HPV types cause almost all cases of anogenital warts in women and men and recurrent respiratory papillomatosis.

From 2014 through 2018, approximately 46,143 new cases of HPV-associated cancers* occurred each year in the United States (25,719 among women and 20,424 among men). Cervical cancer, the most widely known HPV-associated cancer, caused an average of 12,200 cases in the U.S. each year during that time. HPV is also associated with vulvar, and vaginal cancer in females, penile cancer in males, and anal and oropharyngeal cancer in both females and males. Between 2014 and 2018, oropharyngeal cancers were the most commonly occurring HPV-associated cancers, with an average of 20,236 reported cases each year (16,680 among men and 3,556 among women). See www.cdc.gov/cancer/hpv/statistics/cases.htm for more information on trends in HPV-associated cancer.

*Note: CDC defines HPV-associated cancer as cancers at specific anatomic sites with specific cell types in which HPV DNA is frequently found. These parts of the body include the cervix, vagina, vulva, penis, anus, and oropharynx.

Which types of HPV are most likely to cause disease?

In the United States, approximately 80% of HPV-related cancers are attributable to HPV 16 or 18 which are included in all three HPV vaccines that have been available in the U.S. Approximately 12% are attributable to HPV types 31, 33, 45, 52, and 58 (16% of all HPV-attributable cancers for females; 6% for males; approximately 3,800 cases annually), which are included in the 9-valent HPV vaccine. HPV types 16, 18, 31, 33, 45, 52, or 58 account for about 81% of cervical cancers in the United States. HPV types 6 or 11 cause 90% of anogenital warts (condylomata) and most cases of recurrent respiratory papillomatosis.

Is there a treatment for HPV infection?

There is no treatment for HPV infection. Only HPV-associated lesions including genital warts, recurrent respiratory papillomatosis, precancers, and cancers are treated. Recommended treatments vary depending on the diagnosis, size, and location of the lesion. Local treatment of lesions might not eradicate all HPV containing cells fully; whether available therapies for HPV-associated lesions reduce infectiousness is unclear.

Are healthcare personnel at risk of occupational infection with HPV?

Occupational infection with HPV is possible. Some HPV-associated conditions (including anogenital and oral warts, anogenital intraepithelial neoplasias, and recurrent respiratory papillomatosis) are treated with laser or electrosurgical procedures that could produce airborne particles. These procedures should be performed in an appropriately ventilated room using standard precautions and local exhaust ventilation. Workers in HPV research laboratories who handle wild-type viruses or "quasi virions" might be at risk of acquiring HPV from occupational exposures. In the laboratory setting, proper infection control should be instituted including, at minimum, biosafety level 2. Whether HPV vaccination would be of benefit in these settings is unclear because no data exist on transmission risk or vaccine efficacy in this situation.

Can human papillomavirus (HPV) be transmitted by non-sexual transmission routes, such as clothing, undergarments, sex toys, or surfaces?

Nonsexual HPV transmission is theoretically possible but has not been definitely demonstrated. This is mainly because HPV can't be cultured and DNA detection from the environment is difficult and likely prone to false negative results.

If a person has been infected with a wild-type strain of HPV can they be reinfected with the same strain?

If a person is infected with an HPV strain that does not clear (that is, the person becomes persistently infected) the person cannot be reinfected because they are continuously infected. If a person is infected with an HPV strain that clears, some but not all persons will have a lower chance of reinfection with the same strain. Data suggest that females are more likely than males to develop immunity after clearance of natural infection. Prior infection with an HPV strain does not lessen the chance of infection with a different HPV strain.

Vaccine Recommendations Back to top

Please describe the HPV vaccines available in the United States.

Gardasil 9 (9vHPV, Merck) is the only HPV vaccine being distributed in the United States. Bivalent Cervarix (2vHPV, GlaxoSmithKline) and quadrivalent Gardasil (4vHPV, Merck) are no longer being distributed in the United States.

9vHPV is an inactivated 9-valent vaccine licensed by the Food and Drug Administration (FDA) in 2014. It contains 7 oncogenic (cancer-causing) HPV types (16, 18, 31, 33, 45, 52, and 58) and two HPV types that cause most genital warts (6 and 11). The 9vHPV vaccine is licensed for females and males age 9 through 45 years.

What are the recommendations for use of HPV vaccine in people age 9 through 26 years?

The ACIP recommends that routine HPV vaccination be initiated for all children at age 11 or 12 years. Vaccination can be started as early as age 9 years. Vaccination is also recommended for all people age 13 through 26 years who have not been vaccinated previously or who have not completed the vaccination series.

Are catch-up recommendations for the use of HPV vaccine different for males and females?

No. In June 2019, the Advisory Committee on Immunization Practices (ACIP) voted to recommend routine catch-up HPV vaccination of all previously unvaccinated or incompletely vaccinated males age 22 through 26, the same as the recommendation for females. HPV vaccination recommendations differ by age group. There is one recommendation for people 9 through 26 years of age and another recommendation for people 27 through 45 years of age.

The most current ACIP recommendations for HPV vaccine are available at www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6832a3-H.pdf.

What are the recommendations for use of HPV vaccine in people age 27 through 45 years?

Catch-up HPV vaccination is not recommended for all adults older than 26 years of age. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated.

Ideally, HPV vaccine should be administered before potential exposure to HPV through sexual contact.

Why is shared clinical decision-making (a discussion between the provider and the patient) recommended to determine whether to provide HPV vaccine to an adult age 27 through 45 years?

Although new HPV infections are most commonly acquired in adolescence and young adulthood, at any age, having a new sex partner is a risk factor for acquiring a new HPV infection. In addition, some persons have specific behavioral or medical risk factors for HPV infection or disease, including men who have sex with men, transgender persons, and persons with immunocompromising conditions. HPV vaccine works to prevent infection among persons who have not been exposed to vaccine-type HPV before vaccination. A discussion with your patient is the best way to decide together how much the patient may benefit from HPV vaccination to prevent new HPV infections.

Why is HPV vaccination not routinely recommended for all adults age 27 through 45 years?

Because HPV acquisition generally occurs soon after first sexual activity, vaccine effectiveness will be lower in older age groups as the result of prior infections. In general, exposure to HPV also decreases among individuals in older age groups. Evidence suggests that although HPV vaccination is safe for adults 27 through 45 years, population benefit would be minimal; nevertheless, some adults who are unvaccinated or incompletely vaccinated might be at risk for new HPV infection and might benefit from vaccination in this age range.

Should I screen my patients age 27 through 45 years for previous HPV infection to determine whether to offer them HPV vaccine?

No. No screening laboratory test can determine whether a person is already immune or still susceptible to any given HPV type. Most sexually active adults have been exposed to one or more HPV types, although not necessarily all of the HPV types targeted by vaccination. HPV vaccine works to prevent infection with vaccine types to which a person is still susceptible.

I have a few patients who received their first or second dose of HPV vaccine at age 26 years or younger, but did not complete the series. Should I routinely complete their series after age 26 years, or do I need to use the shared clinical decision-making approach?

Complete the series based on shared clinical decision-making involving the patient�s risk and desire for protection.

What is the routine schedule for HPV vaccine?

ACIP recommends a routine 2-dose HPV vaccine schedule for adolescents who start the vaccination series before the 15th birthday. The two doses should be separated by 6 to 12 months. The minimum interval between doses is 5 calendar months.

A 3-dose schedule is recommended for all people who start the series on or after the 15th birthday and for people with certain immunocompromising conditions (such as cancer, HIV infection, or taking immunosuppressive drugs). The second dose should be given 1 to 2 months after the first dose and the third dose 6 months after the first dose. The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum interval between the second and third doses of vaccine is 12 weeks. The minimum interval between the first and third dose is 5 calendar months. If the vaccination series is interrupted, the series does not need to be restarted.

I read that HPV vaccination rates are still low. What can we do as providers to improve these rates?

Coverage levels for HPV vaccine are improving but are still inadequate. Results from the Centers for Disease Control and Prevention's 2020 National Immunization Survey-Teen (NIS-Teen) indicate that 77.1% of girls age 13 through 17 years had started the series that they should have completed by age 13 years and 61.4% had completed the series. In 2020, 73.1% of boys age 13 through 17 years had received one dose but only 56% had received all recommended doses. A summary of the 2020 NIS-Teen survey is available at www.cdc.gov/mmwr/volumes/70/wr/mm7035a1.htm.

Providers can improve uptake of this life-saving vaccine in two main ways. First, studies have shown that missed opportunities are occurring. Up to 90% (depending on year of birth) of girls unvaccinated for HPV had a healthcare visit where they received another vaccine such as Tdap, but not HPV. If HPV vaccine had been administered at the same visit, vaccination coverage for one or more doses could be 90% instead of 70%. Second, research has shown that not receiving a healthcare provider's recommendation for HPV vaccine was one of the main reasons parents reported for not vaccinating their adolescent children.

CDC urges healthcare providers to increase the consistency and strength of their recommendation of HPV vaccine, especially when patients are age 11 or 12 years. CDC's "Talking to Parents about HPV Vaccine," available at www.cdc.gov/hpv/hcp/for-hcp-tipsheet-hpv.pdf can help providers with these conversations. For more detailed information about HPV vaccination strategies for providers, visit www.cdc.gov/hpv/hcp/index.html.

Some parents resist HPV vaccination of their 11- and 12-year-olds because they are not sexually active. How should I counter this position?

Explain to the parent that vaccination starting at 11 or 12 years will provide the best protection possible long before the start of any kind of sexual activity. It is standard practice to vaccinate people before they are exposed to an infection, as is the case with measles and the other recommended childhood vaccines. Similarly, we want to vaccinate children before they get exposed to HPV. Studies of HPV vaccine indicate that younger adolescents respond better to the vaccine than older adolescents and young adults. Healthy children vaccinated at this age will need only 2 doses of vaccine rather than 3 doses if vaccinated at an older age. Finally, numerous research studies have shown that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age.

We have several males in our college health service whose records indicate that they received doses of Cervarix. Can we count these doses as valid?

No. Cervarix was not approved or recommended for use in males. Doses of Cervarix administered to males should not be counted and need to be repeated using 9vHPV.

Are additional 9vHPV doses recommended for a person who started a 3-dose series with 2vHPV or 4vHPV and completed the series with one or two doses of 9vHPV?

There is no ACIP recommendation for additional doses of 9vHPV for persons who started the 3-dose series with 2vHPV or 4vHPV and completed the series with 9vHPV.

Does ACIP recommend revaccination with 9vHPV for patients who previously received a 3-dose series of 2vHPV or 4vHPV?

ACIP has not recommended routine revaccination with 9vHPV for persons who have completed a 3-dose series of another HPV vaccine. There are data that indicate revaccination with 9vHPV after a 3-dose series of 4vHPV is safe. Clinicians should decide if the benefit of immunity against 5 additional oncogenic strains of HPV (which cause 12% of HPV-attributable cancers) is justified for their patients.

Is use of HPV vaccine covered under the Vaccines For Children (VFC) program?

Yes.

Are Pap smears still necessary for women who receive HPV vaccine?

Yes. Vaccinated women still need to see their healthcare provider for periodic cervical cancer screening. The vaccine does not provide protection against all types of HPV that cause cervical cancer, so even vaccinated women will still be at risk for some cancers from HPV.

Do women and men whose sexual orientation is same-sex need HPV vaccine?

Yes. HPV vaccine is recommended for females and males regardless of their sexual orientation.

Should transgender persons receive HPV vaccine?

Yes. ACIP recommends routine HPV vaccination for transgender persons as for all adolescents and young adults through age 26 years. Clinicians should discuss the risks of HPV disease and benefits of HPV vaccination with unvaccinated or incompletely vaccinated transgender persons age 27 through 45 years.

What immunocompromising conditions are an indication for a 3-dose HPV schedule?

ACIP recommends vaccination with 3 doses of HPV vaccine for females and males age 9 through 26 years with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity. Examples include B lymphocyte antibody deficiency, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy.

Is asplenia considered to be an indication for a 3-dose HPV schedule?

No. The recommendation for a 3-dose HPV schedule also does not apply to children 9 through 14 years with asthma, chronic granulomatous disease, chronic liver disease, chronic renal disease, central nervous system anatomic barrier defects (such as a cochlear implant), complement deficiency, diabetes, heart disease or sickle cell disease unless the person is receiving immunosuppressive therapy for the condition.

If a patient has been sexually active for a number of years, is it still recommended to give HPV vaccine or to complete the HPV vaccine series?

Yes. HPV vaccine should be administered to people who are already sexually active. Ideally, patients should be vaccinated before onset of sexual activity; however, people who have already been infected with one or more HPV types will still be protected from other HPV types in the vaccine that have not been acquired.

I have a patient who was diagnosed with HPV types 16 and 18. The patient received a properly spaced Gardasil series in 2006 when she was 25 years old. Did the HPV vaccine she received in 2006 fail to protect her?

In clinical trials, HPV vaccines were shown to be highly effective (more than 95%) for prevention of HPV vaccine-type infection and disease among persons without prior infection with the HPV types included in the vaccine. The most likely explanation for this situation is that the patient was exposed to at least HPV types 16 and 18 prior to vaccination. The HPV vaccine is not effective in preventing infection from HPV types a person has been exposed to prior to vaccination. The vaccine also cannot prevent progression of HPV infection or HPV-related disease. The 9vHPV vaccine protects against 9 different types of HPV.

Will patients who have already had genital warts benefit from receiving HPV vaccine?

A history of genital warts or clinically evident genital warts indicates previous infection with HPV, most often type 6 or 11 which cause 90% of genital warts. However, people with this history might not have been infected with both HPV 6 and 11 or with the other HPV types included in HPV vaccine. Vaccination will provide protection against infection with HPV serotypes the patient has not already acquired. Providers should advise their patients/clients that the vaccine will not have a therapeutic effect on existing HPV infection or genital warts. It is important, however, that patients receive a full age-appropriate series of HPV vaccine to get full protection from genital warts, in addition to the cancer-causing HPV types in the vaccine.

Scheduling and Administering Vaccines Back to top

What is the recommended schedule for administering HPV vaccine?

ACIP recommends a routine 2-dose HPV vaccine schedule for adolescents who start the vaccination series before the 15th birthday. The two doses should be separated by 6 to 12 months. The minimum interval between doses is 5 calendar months.

A 3-dose schedule is recommended for people who start the series on or after the 15th birthday and for people with certain immunocompromising conditions (such as cancer, HIV infection, or taking immunosuppressive drugs). The second dose should be given 1 to 2 months after the first dose and the third dose 6 months after the first dose. The minimum interval between the first and second doses of vaccine is 4 weeks. The minimum interval between the second and third doses of vaccine is 12 weeks. The minimum interval between the first and third doses is 5 calendar months. If the vaccination series is interrupted, the series does not need to be restarted.

Has ACIP expressed a preference for the 2-dose over the 3-dose schedule for adolescents 9 through 14 years of age?

Yes. ACIP recommends the 2-dose schedule for people starting the HPV vaccination series before the 15th birthday, as long as they are immunocompetent.

If a dose of HPV vaccine is significantly delayed, do I need to start the series over?

No, do not restart the series. You should continue where the patient left off and complete the series.

Can the 4-day "grace period" be applied to the minimum intervals for HPV vaccine?

Yes.

A 16 year old received the third dose of HPV vaccine 12 weeks after the second dose but only 4 months after the first dose. Should the third dose be repeated?

Yes. If an HPV vaccine dose is administered at less than the recommended minimum interval then the dose should be repeated. The repeat third dose should be repeated 5 months after the first dose or 12 weeks after the invalid third dose, whichever is later.

Does the 2-dose HPV vaccine schedule need to be completed with the same vaccine, or can it include different vaccines (such as bivalent or quadrivalent vaccine)?

The 2-dose schedule can be completed with any combination of HPV vaccine brands as long as dose #1 was given before age 15 years. Dose #2 should be administered 6–12 months after dose #1.

If dose #1 of HPV vaccine was given before the 15th birthday and it has been more than a year since that dose was given, would the series be complete with just one additional dose?

Yes. Adolescents and adults who started the HPV vaccine series prior to the 15th birthday and who are not immunocompromised are considered to be adequately vaccinated with just one additional dose of HPV vaccine.

We have adolescents in our practice who have received the first 2 doses of the HPV series 1 or 2 months apart according to the 3-dose schedule. Can we consider their HPV vaccine series to be complete or do we need to give these patients a third dose?

People who have received 2 doses of HPV vaccine separated by less than 5 months should receive a third dose 6�12 months after dose #1 and at least 12 weeks after dose #2.

Is the 2-dose recommendation retroactive for children and teens vaccinated prior to 2016?

Yes. Any person who ever received 2 doses of any combination of HPV vaccines can be considered fully vaccinated if dose #1 was given before the 15th birthday and the 2 doses were separated by at least 5 months.

I work with university students and many of them miss coming in on time for their next dose of HPV vaccine. What's the longest interval allowed before we need to start the series over?

No vaccine series needs to be restarted because of an interval that is longer than recommended (with the exception of oral typhoid vaccine in certain circumstances). You should continue the series where it was interrupted.

I have read that HPV vaccine should not be administered during pregnancy. Do we need to perform a pregnancy test prior to administering this vaccine to our patients? Currently, we ask about pregnancy prior to providing the vaccine.

HPV vaccine is not recommended for use during pregnancy. HPV vaccines have not been associated causally with adverse outcomes of pregnancy or adverse events in the developing fetus. However, if a person is found to be pregnant after initiating the vaccination series, the remainder of the series should be delayed until completion of pregnancy. Pregnancy testing is not needed before vaccination.

If a vaccine dose has been administered during pregnancy, no intervention is needed.

We inadvertently gave HPV vaccine to a woman who didn't know she was pregnant at the time. How should we complete the schedule?

You should withhold further HPV vaccine until she is no longer pregnant. After the pregnancy is completed, administer the remaining doses of the series using the usual 2- or 3-dose schedule (depending on the age at initiation of the series).

Can HPV vaccine be administered at the same time as other vaccines?

Yes, administration of a different inactivated or live vaccine, either at the same visit or at any time before or after HPV vaccine, is acceptable because HPV is not a live vaccine.

If HPV vaccine is given subcutaneously instead of intramuscularly, does the dose need to be repeated?

Yes. No data exist on the efficacy or safety of HPV vaccine given by the subcutaneous route. All data on efficacy and duration of protection are based on a vaccine series administered by the intramuscular route. In the absence of data on subcutaneous administration, CDC and the manufacturer recommend that a dose of HPV vaccine given by any route other than intramuscular should be repeated. There is no minimum interval between the invalid (subcutaneous) dose and the repeat dose.

Contraindications and Precautions Back to top

What are the contraindications and precautions to HPV vaccine?

Contraindications are the following: HPV vaccine is contraindicated for persons with a history of immediate hypersensitivity to any vaccine component, including yeast. The precaution to HPV vaccine is a moderate or severe acute illness with or without fever. Vaccination should be deferred until the condition improves. HPV vaccines are not recommended for use during pregnancy. If a person is found to be pregnant after starting the vaccination series, the remainder of the 2 or 3-dose series (depending on the age of first HPV vaccination) should be delayed until completion of pregnancy. Pregnancy testing is not needed before vaccination. If a vaccine dose has been administered during pregnancy, no intervention is needed. You can find more information about HPV vaccine and pregnancy in the ACIP recommendations at: www.cdc.gov/mmwr/preview/mmwrhtml/rr6305a1.htm.

If a woman has had HPV infection detected in cervical cancer screening, can she still be vaccinated?

Yes. A woman with evidence of present or past HPV infection identified through cervical screening may be vaccinated. Recipients of HPV vaccinations should be counseled that the vaccine will not have a therapeutic effect on any existing HPV infections or cervical lesions.

Can a woman who is breastfeeding receive HPV vaccine?

Yes.

Is the history of an abnormal Pap test a contraindication to the HPV vaccine series?

No. Even a woman found to be infected with a strain of HPV that is present in the vaccine could receive protection from the other strains in the vaccine.

Vaccine Safety Back to top

What adverse events can be expected following HPV vaccine?

In clinical trials of 9vHPV involving more than 15,000 subjects, the most common adverse event was injection site pain, which was reported in about 90% of recipients. Other local reactions, such as redness and/or swelling, were reported in about 40% of recipients. Fever was less common, reported by about 6% of recipients. The rates and severity of adverse reactions following each dose of 9vHPV were similar between boys and girls.

We've heard stories in the media about severe reactions to the HPV vaccine. Is there any substance to these stories?

No. Since 2006, more than 120 million doses of HPV vaccine have been distributed in the United States. Among all reports to the Vaccine Adverse Event Reporting System (VAERS) following HPV vaccines, the most frequently reported symptoms overall were dizziness; fainting; headache; nausea; fever; and pain, redness, and swelling in the arm where the shot was given. Of the reports to VAERS, 6% were classified as "serious." About 22% of the VAERS reports were not related to health problems, but were reported for reasons such as improper vaccine storage or the vaccine being given to someone for whom it was not recommended. Although deaths have been reported among vaccine recipients none has been conclusively shown to have been caused by the vaccine. Occurrences of rare conditions, such as Guillain-Barré Syndrome (GBS) have also been reported among vaccine recipients but there is no evidence that HPV vaccine increased the rate of GBS above what is expected in the population.

CDC, working with the FDA and other immunization partners, will continue to monitor the safety of HPV vaccines. You can find complete information on this and other vaccine safety issues at www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html.

Do HPV vaccines cause fainting?

Nearly all vaccines have been reported to be associated with fainting (syncope). Post-vaccination syncope has been most frequently reported after three vaccines commonly given to adolescents (HPV, MenACWY, and Tdap). However, it is not known whether the vaccines are responsible for post-vaccination syncope or if the association with these vaccines simply reflects the fact that adolescents are generally more likely to experience syncope.

Syncope can cause serious injury. Falls that occur due to syncope after vaccination can be prevented by having the vaccinated person seated or lying down. The person should be observed for 15 minutes following vaccination.

How should HPV vaccine be stored?

HPV vaccine should be stored at refrigerator temperature between 2°C and 8°C (36°F and 46°F). The vaccine must not be frozen and must not be used if it has been frozen. Protect the vaccine from light. Administer as soon as possible after being removed from refrigeration. The manufacturer package insert contains additional information and can be found at www.immunize.org/packageinserts. For complete information on vaccine storage and handling best practices and recommendations please refer to CDC's Vaccine Storage and Handling Toolkit at www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf.

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Source: https://www.immunize.org/askexperts/experts_hpv.asp

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