Effectiveness and B-memory Cell Response to QHPV Vaccine 9-years Post-vaccination Among HIV-infected Boys and Girls

NCT04920526 | Unknown FDA Drug

• 1 other identifier: MISP 60583
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

In 2013, the Investigators enrolled a cohort of 180 HIV-1 infected adolescent girls and boys ages 9-14 years and administered three doses of the QHPV vaccine (NCT04711265). For this study, the Investigators shall evaluate vaccine effectiveness 9 years post first vaccination. Participants will be evaluated for HPV type specific antibody, genital HPV infection, genital warts and a subset of 30 participants will be evaluated for memory B and T cell responses.

Conditions

HPV-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• Changes in persistent Genital HPV infection

  Type specific HPV serotype: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes 31,33,35,39,45,51,52,56,58,59,66, 68,73 as per International Agency for Research on Cancer (IARC) monographs.

  The changes will be measured at baseline (enrolment), month 6 and 12

• Changes in geometric titers for HPV-specific Antibodies

  Vaccine type specific HPV antibody Geometric Mean Titers: HPV- 6, 11, 16 \& 18

  This outcome will be measured at Month 12

• B-memory cell elicitation in the participants given a booster vaccine

  Elicited from Peripheral Blood Mononuclear Cell (PBMC)

  This will be measured at 12 months after receiving a booster vaccine

Study Arms (1)

QHPV Vaccine

all participants have received QHPV

Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine

Interventions

Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine DRUG

No intervention will be administered

Also known as: Gardasil

QHPV Vaccine

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to enroll 135 HIV-1 infected boys and girls, who previously received three doses of quadrivalent HPV vaccine in the safety and immunogenicity study (MISP 38406)

You may qualify if:

• received three doses of the quadrivalent HPV vaccine and enrolled in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
• participant consent or parental/guardian consent and participant assent for participants still \<18 years of age
• participants and guardians who consented to be contacted for further evaluation and participation in research and
• are willing to continue longer-term follow up.

You may not qualify if:

• Did not participate in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
• Not willing or able to provide written informed consent/assent to participate in the study

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• University of Washington: collaborator

Related Publications (14)

• MacIntyre CR, Shaw P, Mackie FE, Boros C, Marshall H, Barnes M, Seale H, Kennedy SE, Moa A, Hayen A, Chughtai AA, O'Loughlin EV, Stormon M. Immunogenicity and persistence of immunity of a quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2016 Aug 5;34(36):4343-50. doi: 10.1016/j.vaccine.2016.06.049. Epub 2016 Jul 9.

  PMID: 27406936 RESULT

• Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Harjula K, Kuortti M, Natunen K, Palmroth J, Petaja T, Pukkala E, Siitari-Mattila M, Struyf F, Nieminen P, Paavonen J, Dubin G, Dillner J. Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials. BMJ Open. 2017 Aug 18;7(8):e015867. doi: 10.1136/bmjopen-2017-015867.

  PMID: 28821519 RESULT

• Moscicki AB, Karalius B, Tassiopoulos K, Yao TJ, Jacobson DL, Patel K, Purswani M, Seage GR; Pediatric HIV/AIDS Cohort Study. Human Papillomavirus Antibody Levels and Quadrivalent Vaccine Clinical Effectiveness in Perinatally Human Immunodeficiency Virus-infected and Exposed, Uninfected Youth. Clin Infect Dis. 2019 Sep 13;69(7):1183-1191. doi: 10.1093/cid/ciy1040.

  PMID: 30927547 RESULT

• MacIntyre CR, Shaw PJ, Mackie FE, Boros C, Marshall H, Seale H, Kennedy SE, Moa A, Chughtai AA, Trent M, O'Loughlin EV, Stormon M. Long term follow up of persistence of immunity following quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2019 Sep 3;37(37):5630-5636. doi: 10.1016/j.vaccine.2019.07.072. Epub 2019 Aug 8.

  PMID: 31402238 RESULT

• Weinberg A, Huang S, Moscicki AB, Saah A, Levin MJ; IMPAACT P1085 Protocol Team. Persistence of memory B-cell and T-cell responses to the quadrivalent HPV vaccine in HIV-infected children. AIDS. 2018 Apr 24;32(7):851-860. doi: 10.1097/QAD.0000000000001773.

  PMID: 29424778 RESULT

• Einstein MH, Levin MJ, Chatterjee A, Chakhtoura N, Takacs P, Catteau G, Dessy FJ, Moris P, Lin L, Struyf F, Dubin G; HPV-010 Study Group. Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: follow-up through Month 48 in a Phase III randomized study. Hum Vaccin Immunother. 2014;10(12):3455-65. doi: 10.4161/hv.36117.

  PMID: 25483700 RESULT

• Banatvala J, Van Damme P, Van Hattum J. Boosters for hepatitis B. European Consensus Group on Hepatitis B Immunity. Lancet. 2000 Jul 22;356(9226):337-8. doi: 10.1016/s0140-6736(05)73618-7. No abstract available.

  PMID: 11071210 RESULT

• Mugo NR, Eckert L, Magaret AS, Cheng A, Mwaniki L, Ngure K, Celum C, Baeten JM, Galloway DA, Wamalwa D, Wald A. Quadrivalent HPV vaccine in HIV-1-infected early adolescent girls and boys in Kenya: Month 7 and 12 post vaccine immunogenicity and correlation with immune status. Vaccine. 2018 Nov 12;36(46):7025-7032. doi: 10.1016/j.vaccine.2018.09.059. Epub 2018 Oct 5.

  PMID: 30297124 RESULT

• Pinto LA, Dillner J, Beddows S, Unger ER. Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development. Vaccine. 2018 Aug 6;36(32 Pt A):4792-4799. doi: 10.1016/j.vaccine.2017.11.089. Epub 2018 Feb 1.

  PMID: 29361344 RESULT

• Levin MJ, Huang S, Moscicki AB, Song LY, Read JS, Meyer WA, Saah AJ, Richardson K, Weinberg A; IMPAACT P1085 Protocol Team. Four-year persistence of type-specific immunity after quadrivalent human papillomavirus vaccination in HIV-infected children: Effect of a fourth dose of vaccine. Vaccine. 2017 Mar 23;35(13):1712-1720. doi: 10.1016/j.vaccine.2017.02.021. Epub 2017 Feb 24.

  PMID: 28238631 RESULT

• Pathak N, Dodds J, Zamora J, Khan K. Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. BMJ. 2014 Sep 16;349:g5264. doi: 10.1136/bmj.g5264.

  PMID: 25232064 RESULT

• Van Keer S, Tjalma WAA, Pattyn J, Biesmans S, Pieters Z, Van Ostade X, Ieven M, Van Damme P, Vorsters A. Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples. Eur J Clin Microbiol Infect Dis. 2018 May;37(5):859-869. doi: 10.1007/s10096-017-3179-1. Epub 2018 Feb 7.

  PMID: 29417310 RESULT

• Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. doi: 10.1016/j.vaccine.2007.03.049. Epub 2007 Apr 20.

  PMID: 17499406 RESULT

• Smith JS, Lindsay L, Hoots B, Keys J, Franceschi S, Winer R, Clifford GM. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int J Cancer. 2007 Aug 1;121(3):621-32. doi: 10.1002/ijc.22527.

  PMID: 17405118 RESULT

Related Links

• Gardasil product information

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Nelly R. Mugo, MMed Obs Gyn

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelly Mugo, MD

CONTACT

254733629665; rwamba@uw.edu

Peter Mogere

CONTACT

+254707177811; patandi@pipsthika.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 10, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 10, 2021

Record last verified: 2021-06