Study Purpose
The purpose of this research is to determine if the immune response to Gardasil 9, the HPV vaccine available in the US, is the same in 4−8-year-old children as it is in children 9 years and older. We also want to determine whether the vaccine is as safe for 4−8 year old as it is for children 9 years and older. The information obtained from this study will help medical providers understand what the best vaccination regimen is to prevent HPV-related cancers. It is your decision whether or not to agree for your daughter or son to join the study.
Participants receive 2 doses of the HPV vaccine, the first dose at enrollment and the second at 12 months.
Participants undergo 4 blood tests, at 13 months, month 30, month 42, and month 60. This is to measure immunity against HPV.
Eligibility
- Your child is 4 to 8 years of age
- Your child is a current BMC patient
Note: This is a 5-year study. Please only contact us if you are planning to stay in the area.
Compensation
Parents of qualifying participants will receive $400 in study cards (can be used like credit cards) over the course of the study.
How to Participate
Please call 617.851.1537 or email HPV@bmc.org if you are interested in allowing your child to participate.
Frequently Asked Questions
What is HPV?
HPV = Human Papilloma Virus
HPV is a different virus than HIV and HSV (herpes)
The human papillomavirus, abbreviated as HPV, is a group of DNA viruses with more than 200 known types. Most HPV viruses cause skin warts, which are considered low-risk HPV types since they are not cancer-causing.
HPV vaccine types 6 and 11 can cause abnormalities in cells of the cervix, anogenital warts, and respiratory papillomas.
Although most HPV viruses are considered low-risk, the high-risk types are associated with many types of cancers including cervical cancer. High-risk HPV virus types 16 and 18 cause two-thirds of known cervical cancers. Types 31, 33, 45, 52, and 58 are also considered high-risk since they can cause cancer. All high-risk types stated above are protected against in the Gardasil 9vHPV vaccine.
Contracting HPV is extremely common. Almost everyone will get infected in their lifetime.
Over 42 million Americans currently are infected with disease-causing HPV
Approximately 13 million Americans get HPV each year
HPV is transmitted by intimate skin-to-skin contact with someone who already is infected with HPV.
HPV may remain dormant, or inactive, in the body for years after contracting the virus, so it might be difficult to know when and where the virus was contracted. In fact, most people with HPV do not even know that they have contracted it if they do not have symptoms. The immune system will normally get rid of the virus over the course of two years.
How an HPV Infection Can Lead to Cancer
If the immune system cannot rid itself of HPV infection, high-risk HPV types over time may cause normal cells to turn into cancerous cells.
Cancers Associated with HPV
Every year in the United States, HPV causes about 36,000 cases of cancer in men and women.
The most common HPV-associated cancer is cervical cancer in women. The cervix is located in the reproductive tract in the lowest part of the uterus. Other cancers linked to HPV are cancers of the vulva and vagina for women and cancers of the penis for men. Additionally, HPV can cause cancers of the anus and back of the throat.
Early protection works best. Early HPV vaccination is recommended to protect your child before they are at risk of contracting the virus. https://www.cdc.gov/cancer/hpv/basic_info/cancers.htm
HPV Vaccine
HPV vaccination significantly reduces your chances of getting HPV. The 9-valent (9vHPV) vaccine protects against 6, 11, 16, and 18, the types targeted by the quadrivalent HPV vaccine (4vHPV), as well as HPV types 31, 33, 45, 52, and 58.
Centers for Disease Control (CDC) recommends HPV vaccination at age 11 or 12 but can start at age 9 and for everyone through age 26 years. Vaccination is not recommended for everyone older than age 26 years
HPV Vaccine Side Effects
The HPV vaccine lowers the chances of contracting HPV. Gardasil-9 (9vHPV) protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
HPV vaccine 9vHPV (Gardasil) works to protect against the HPV types that are associated with cancer as well as the HPV types that cause most genital warts.
The HPV vaccine can be given to anyone aged 9 to 26. The Center for Disease Control (CDC) recommends that the HPV vaccine be given at age 11 or 12.
Adults aged 27 through 45 may be eligible to receive the HPV vaccine after speaking with their doctor.
Children 14 and younger are only required to receive 2 doses of the vaccine. In individuals 15 and older, three doses are needed.
Most common side effects include:
- Pain, redness, or swelling in the arm where the shot was given
- Fever
- Dizziness or fainting (fainting after any vaccine, including the HPV vaccine, is more common among adolescents)
- Nausea
- Headache or feeling tired
- Muscle or joint pain
HPV vaccine does not cause HPV infection or cancer. HPV vaccine is made from one protein from the virus and is not infectious, meaning that it cannot cause HPV infection or cancer. There is no evidence to suggest that the HPV vaccine causes fertility problems. Not getting HPV vaccine leaves people vulnerable to HPV cancers and pre-cancers (abnormal cells that can lead to cancer).
HPV vaccine is cancer prevention. Ask about it for your child.
Investigator
Principal Investigator: Natalie Pierre-Joseph MD, MPH
Phone: 781.879.4841
Email: natalie.pierrejoseph@bmc.org
Sponsored in part by a research grant from Investigator-initiated Studies Program of Merck Sharp & Dohme Corp. The opinions expressed in this promotion are those of the authors and do not necessarily reflect those of Merck Sharp & Dohme Corp.