An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen over 6 months Among Women Aged 16 to 45 years old, An Exploratory Immunogenicity Study
ClinicalTrials.gov number: NCT04206813
Protocol Version Number: 6
Protocol Version Date: 2/16/2021
Funding Mechanism Sponsor: Merck grant MISP #59402
Principal Investigator: Dr. Natalie Pierre Joseph
Phone: (781) 879-4841
E-mail: [email protected]
Evaluating the dosing schedule of the 9vHPV Vaccine in women ages 16-45. The HPV Vaccine is Cancer Prevention.
Natalie Pierre-Joseph, MD, MPH of Boston Medical Center’s Department of Pediatrics and Adolescent Medicine is conducting an exploratory immunogenicity study. This open-label clinical trial aims to evaluate the immune response produced by the Gardasil 9vHPV Vaccine over 6 months among women aged 16 to 45 years old.
The study will comprise two groups, an intervention group and a standard/control group. Both groups will receive 3 doses of the vaccine, a $750 savings for women who have aged out of the vaccine recommendation group. The intervention group will receive each dose at 0, 6, and 12 months while the standard group receives each dose at 0, 2, and 6 months. This will allow us to compare immune response from a 2-dose schedule to a 3-dose schedule at month 7. Immunogenicity will be assessed by comparing the geometric mean titers (GMTs) (HPV titers) by HPV type from the 2 groups at month 7.
Since 2006 HPV vaccine ( quadrivalent) has won green lights for use in the U.S. in girls and young women aged 9-26 and boys 9-15 years old. In 2018, Gardasil 9 vaccine was approved for the older age range. In 2019, the Centers for Disease Control and Prevention (CDC) recommended vaccination with Gardasil 9 (9v HPV vaccine) for adults through the age of 45 who had not been properly vaccinated as adolescents. Nine strains of the HPV virus can be prevented by the Gardasil 9 vaccine, including two strains believed to cause 70% of cervical cancers.
The 9vHPV Vaccine(Gardasil 9) prevents cervical cancer in women as well as other forms of HPV-related cancers and adverse outcomes like genital warts in both men and women. As an exploratory study, the results of this study may guide a future efficacy study that could impact clinical recommendations and policy, potentially making a 2-dose regimen licensed for women ages 16 to 45 years. Generally, fewer doses results in higher compliance and great financial savings in a population. Higher compliance with 9vHPV vaccination would have beneficial effects for the entire population by reducing the potential risk for certain HPV-related cancers and diseases because the HPV vaccine is cancer prevention.